Document Center List of Standards on Implants For Surgery, Prosthetics And Orthotics Including Pacemakers Ophthalmic Implants, See 11.040.70
ICS Code 11.040.40
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-E1505 - Standard Guide for Determining SIMS Relative Sensitivity Factors from Ion Implanted External Standards (Withdrawn 2010)
- ASTM-E3087 - Standard Test Method for Measuring Capture Efficiency of Domestic Range Hoods
- ASTM-F1027 - Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
- ASTM-F1058 - Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
- ASTM-F1088 - Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
- ASTM-F1091 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
- ASTM-F1108 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
- ASTM-F1109 - Specification for Porous Composites of Polytetrafluoroethylene and Carbon for Surgical Implant Applications (Withdrawn 1993)
- ASTM-F117 - Test Method for Driving Torque of Medical Bone Screws (Withdrawn 2001)
- ASTM-F1185 - Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
- ASTM-F1223 - Standard Test Method for Determination of Total Knee Replacement Constraint
- ASTM-F1235 - Standard Consumer Safety Specification for Portable Hook-On Chairs
- ASTM-F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices
- ASTM-F1295 - Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
- ASTM-F1314 - Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
- ASTM-F1341 - Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications (Withdrawn 2006)
- ASTM-F1350 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
- ASTM-F1357 - Standard Specification for Articulating Total Wrist Implants
- ASTM-F136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
- ASTM-F1377 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
- ASTM-F1378 - Standard Specification for Shoulder Prostheses
- ASTM-F138 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM-F139 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
- ASTM-F1408 - Standard Practice for Subcutaneous Screening Test for Implant Materials
- ASTM-F1439 - Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
- ASTM-F1440 - Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion (Withdrawn 2012)
- ASTM-F1472 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
- ASTM-F1537 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
- ASTM-F1538 - Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation
- ASTM-F1539 - Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples (Withdrawn 2000)
- ASTM-F1540 - Test Method for Pull-Out Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
- ASTM-F1541 - Standard Specification and Test Methods for External Skeletal Fixation Devices
- ASTM-F1542 - Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)
- ASTM-F1579 - Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)
- ASTM-F1580 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
- ASTM-F1581 - Standard Specification for Composition of Anorganic Bone for Surgical Implants
- ASTM-F1582 - Standard Terminology Relating to Spinal Implants
- ASTM-F1586 - Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
- ASTM-F1609 - Standard Specification for Calcium Phosphate Coatings for Implantable Materials
- ASTM-F1610 - Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples (Withdrawn 2000)
- ASTM-F1612 - Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion (Withdrawn 2011)
- ASTM-F1622 - Test Method for Measuring the Torsional Properties of Metallic Bone Screws (Withdrawn 2001)
- ASTM-F1634 - Standard Practice for
In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices (Withdrawn 2017) - ASTM-F1635 - Standard Test Method for
in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants - ASTM-F1636 - Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)
- ASTM-F1660 - Test Method for Elastic Static Bending of Metallic Bone Staples (Withdrawn 2000)
- ASTM-F1672 - Standard Specification for Resurfacing Patellar Prosthesis
- ASTM-F1691 - Test Method for Determining Axial Pull-Out Strength of Medical Bone Screws (Withdrawn 2001)
- ASTM-F1713 - Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
- ASTM-F1714 - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
- ASTM-F1715 - Standard Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices (Withdrawn 2006)
- ASTM-F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM-F1781 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
- ASTM-F1798 - Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM-F1800 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
- ASTM-F1801 - Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
- ASTM-F1814 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
- ASTM-F1820 - Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
- ASTM-F1828 - Standard Specification for Ureteral Stents
- ASTM-F1829 - Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- ASTM-F1831 - Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
- ASTM-F1854 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024)
- ASTM-F1873 - Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)
- ASTM-F1875 - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ASTM-F1876 - Standard Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications (Withdrawn 2012)
- ASTM-F1903 - Standard Practice for Testing for Cellular Responses to Particles
in vitro - ASTM-F1904 - Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products
in vivo - ASTM-F1925 - Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
- ASTM-F1926 - Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
- ASTM-F1983 - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
- ASTM-F2009 - Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- ASTM-F2025 - Standard Practice for Gravimetric Measurement of Polymeric Components for Wear Assessment
- ASTM-F2027 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
- ASTM-F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
- ASTM-F2033 - Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
- ASTM-F2038 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
- ASTM-F2042 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
- ASTM-F2051 - Standard Specification for Implantable Saline Filled Breast Prosthesis
- ASTM-F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM-F2064 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
- ASTM-F2065 - Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
- ASTM-F2068 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
- ASTM-F2083 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
- ASTM-F2091 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
- ASTM-F2102 - Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
- ASTM-F2119 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM-F2129 - Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- ASTM-F2146 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
- ASTM-F2180 - Standard Specification for Metallic Implantable Strands and Cables
- ASTM-F2181 - Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
- ASTM-F2182 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
- ASTM-F2183 - Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
- ASTM-F2193 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- ASTM-F2212 - Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
- ASTM-F2224 - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
- ASTM-F2229 - Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
- ASTM-F2256 - Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
- ASTM-F2257 - Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
- ASTM-F2258 - Standard Test Method for Strength Properties of Tissue Adhesives in Tension
- ASTM-F2267 - Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM-F2313 - Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
- ASTM-F2345 - Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- ASTM-F2346 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
- ASTM-F2381 - Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
- ASTM-F2385 - Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
- ASTM-F2392 - Standard Test Method for Burst Strength of Surgical Sealants
- ASTM-F2393 - Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
- ASTM-F2401 - Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
- ASTM-F2423 - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
- ASTM-F2428 - Standard Guide for Selection and Use for Pelvic Ring Circumferential Compression Stabilization Devices (PRCCSD) (Withdrawn 2020)
- ASTM-F2451 - Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
- ASTM-F2502 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- ASTM-F2514 - Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
- ASTM-F2527 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
- ASTM-F2565 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- ASTM-F2579 - Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
- ASTM-F2580 - Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses
- ASTM-F2581 - Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
- ASTM-F2582 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
- ASTM-F2603 - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
- ASTM-F2606 - Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
- ASTM-F2624 - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
- ASTM-F2694 - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
- ASTM-F2695 - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
- ASTM-F2706 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
- ASTM-F2722 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
- ASTM-F2723 - Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
- ASTM-F2724 - Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
- ASTM-F2743 - Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
- ASTM-F2759 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
- ASTM-F2777 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
- ASTM-F2789 - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
- ASTM-F2790 - Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
- ASTM-F2847 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
- ASTM-F2885 - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
- ASTM-F2886 - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
- ASTM-F2895 - Standard Practice for Digital Radiography of Cast Metallic Implants
- ASTM-F2902 - Standard Guide for Assessment of Absorbable Polymeric Implants
- ASTM-F2914 - Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
- ASTM-F2942 - Standard Guide for
in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents - ASTM-F2943 - Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
- ASTM-F2977 - Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
- ASTM-F2978 - Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
- ASTM-F2979 - Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
- ASTM-F2989 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
- ASTM-F2996 - Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- ASTM-F3018 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
- ASTM-F3036 - Standard Guide for Testing Absorbable Stents
- ASTM-F3037 - Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
- ASTM-F3044 - Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- ASTM-F3047M - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
- ASTM-F3067 - Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
- ASTM-F3087 - Standard Specification for Acrylic Molding Resins for Medical Implant Applications
- ASTM-F3106 - Standard Guide for
in vitro Osteoblast Differentiation Assays - ASTM-F3129 - Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
- ASTM-F3140 - Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
- ASTM-F3141 - Standard Guide for Total Knee Replacement Loading Profiles
- ASTM-F3160 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
- ASTM-F3161 - Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
- ASTM-F3172 - Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
- ASTM-F3207 - Standard Guide for
in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model - ASTM-F3211 - Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
- ASTM-F3223 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
- ASTM-F3225 - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
- ASTM-F3273 - Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
- ASTM-F3306 - Standard Test Method for Ion Release Evaluation of Medical Implants
- ASTM-F337 - Recommended Practice for Dimensions and Tolerances for Bone Plates (Withdrawn 1982)
- ASTM-F343 - Counterlocking Screws (Mclaughlin Type), Specification For
- ASTM-F367 - Specification for Holes and Slots for Inch Cortical Bone Screws (Withdrawn 1997)
- ASTM-F370 - Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
- ASTM-F382 - Standard Specification and Test Method for Metallic Bone Plates
- ASTM-F384 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- ASTM-F451 - Standard Specification for Acrylic Bone Cement
- ASTM-F452 - Standard Specification for Preformed Cranioplasty Plates
- ASTM-F453 - Specification for Hooked Intramedullary Pins (Withdrawn 1994)
- ASTM-F454 - Specification for Intramedullary Pins (Withdrawn 1994)
- ASTM-F455 - Specification for Solid Cross-Section Intramedullary Nails (Withdrawn 1994)
- ASTM-F500 - Specification for Self-Curing Acrylic Resins Used in Neurosurgery (Withdrawn 1993)
- ASTM-F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM-F544 - Reference Chart for Pictorial Cortical Bone Screw Classification (Withdrawn 1998)
- ASTM-F55 - Specification for Stainless Steel Bar and Wire for Surgical Implants (Withdrawn 1989)
- ASTM-F56 - Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)
- ASTM-F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
- ASTM-F561 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
- ASTM-F562 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
- ASTM-F563 - Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
- ASTM-F565 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ASTM-F601 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
- ASTM-F602 - Standard Criteria for Implantable Thermoset Epoxy Plastics (Withdrawn 2024)
- ASTM-F603 - Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
- ASTM-F620 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
- ASTM-F621 - Standard Specification for Stainless Steel Forgings for Surgical Implants
- ASTM-F622 - Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
- ASTM-F629 - Standard Practice for Radiography of Cast Metallic Surgical Implants
- ASTM-F641 - Standard Specification for Implantable Epoxy Electronic Encapsulants
- ASTM-F643 - Specification for Wrought Cobalt-Chromium Alloy Flexible Wire for Surgical Fixations for Soft Tissue (Withdrawn 1993)
- ASTM-F644 - Specification for Wrought Cobalt-Chromium Alloy Flexible Wire for Surgical Fixations for Bone (Withdrawn 1993)
- ASTM-F647 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
- ASTM-F648 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ASTM-F665 - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
- ASTM-F666 - Specification for Stainless Steel Flexible Wire for Surgical Fixation of Bone (Withdrawn 1993)
- ASTM-F67 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
- ASTM-F688 - Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
- ASTM-F701 - Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)
- ASTM-F703 - Standard Specification for Implantable Breast Prostheses
- ASTM-F732 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
- ASTM-F745 - Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
- ASTM-F746 - Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
- ASTM-F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
- ASTM-F754 - Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
- ASTM-F755 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
- ASTM-F763 - Standard Practice for Short-Term Screening of Implant Materials
- ASTM-F799 - Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
- ASTM-F86 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
- ASTM-F881 - Standard Specification for Silicone Elastomer Facial Implants
- ASTM-F897 - Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
- ASTM-F898 - Practice for Permanent Marking of Orthopedic Implant Components (Withdrawn 1990)
- ASTM-F90 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
- ASTM-F961 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
- ASTM-F981 - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
- ASTM-F982 - Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
- ASTM-F983 - Standard Practice for Permanent Marking of Orthopaedic Implant Components
- ASTM-PS5 - Test Method for Static and Dynamic Test Method for Spinal Implants Assembly in a Corpectomy Model (Withdrawn 1997)
BSI:
- BS-2574-1 - Lower limb orthoses
- BS-2574-2 - Lower limb orthoses
- BS-3531-11 - Implants for osteosynthesis
- BS-3531-14.1 - Specification for the Dimensions of Nails of Clover Leaf & V-Shaped Cross Section & Di
- BS-3531-14.2 - Implants for osteosynthesis. Intramedullary nailing systems
- BS-3531-15 - Implants for osteosynthesis
- BS-3531-16 - Surgical implants
- BS-3531-2 - Surgical implants
- BS-3531-22 - Surgical implants
- BS-3531-23.1 - Implants for osteosynthesis. Bone plates
- BS-3531-23.2 - Implants for osteosynthesis. Bone plates
- BS-3531-23.3 - Implants for osteosynthesis. Bone plates
- BS-3531-3 - Surgical implants
- BS-3531-5 - Surgical implants
- BS-3531-5.1 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.2 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.3 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.4 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.5 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.6 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-5.7 - Implants for osteosynthesis. Bone screws and auxiliary equipment
- BS-3531-6 - Surgical implants
- BS-3531-6.1 - Implants for osteosynthesis. Skeletal pins and wires
- BS-3531-6.2 - Implants for osteosynthesis. Skeletal pins and wires
- BS-3531-6.3 - Implants for osteosynthesis. Skeletal pins and wires
- BS-6324-1 - Terms relating to surgical implants
- BS-6324-2 - Terms relating to surgical implants
- BS-6324-3 - Terms relating to surgical implants
- BS-6324-4 - Terms relating to surgical implants
- BS-6902-1-S-1 - Cardiac pacemakers. Specification for implantable cardiac pacemakers. Electromagnetic compatibility
- BS-6902-2 - Cardiac pacemakers. Method for reporting the clinical performance of populations of pulse generators
- BS-7251-10 - Orthopaedic joint prostheses
- BS-7251-13 - Orthopaedic joint prostheses. Method for determination of resistance to torque of head fixation of stemmed femoral components
- BS-7251-14 - Orthopaedic joint prostheses
- BS-7251-5 - Orthopaedic joint prostheses. Method for determination of endurance properties of stemmed femoral components of hip joint prostheses with application of torsion
- BS-7252-1 - Metallic materials for surgical implants. Specification for wrought stainless steel
- BS-7252-10 - Metallic materials for surgical implants
- BS-7252-11 - Metallic materials for surgical implants
- BS-7252-2 - Metallic materials for surgical implants. Specification for unalloyed titanium
- BS-7252-3 - Metallic materials for surgical implants. Specification for wrought titanium 6-aluminium 4-vanadium alloy
- BS-7252-4 - Metallic materials for surgical implants
- BS-7252-6 - Metallic materials for surgical implants
- BS-7252-7 - Metallic materials for surgical implants
- BS-7252-8 - Metallic materials for surgical implants
- BS-7253-2 - Non-metallic materials for surgical implants. Specification for ceramic materials based on high purity alumina
- BS-7253-3 - Non-metallic materials for surgical implants. Specification for surgical implants made of heat-vulcanized silicone elastomer
- BS-7253-6 - Non-metallic materials for surgical implants
- BS-7254-2 - Orthopaedic implants
- BS-7254-3 - Orthopaedic implants
- BS-7254-4 - Orthopaedic implants
- BS-7254-6.2 - Orthopaedic implants. Forgings
- BS-7297-1 - Haemodialysers and related equipment. Specification for haemodialysers, haemofilters and haemoconcentrators
- BS-7297-2 - Haemodialysers and related equipment. Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators
- BS-8432 - Spinal orthoses. Guide to design
- BS-EN-12006-1 - Part 1: Heart Valve Substitutes, Non-Active Surgical Implants - Particular Requirements Fo
- BS-EN-12006-2 - Non active surgical implants. Particular requirements for cardiac and vascular implants. Vascular prostheses including cardiac valve conduits
- BS-EN-12006-3 - Non active surgical implants. Particular requirements for cardiac and vascular implants. Endovascular devices
- BS-EN-12010 - Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements
- BS-EN-12180 - Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants
- BS-EN-12523 - External Limb Prostheses & External Orthoses. Requirements & Test Methods
- BS-EN-12563 - Non-Active Surgical Implants - Joint Replacement Implants -Specific Requirements for Hip J
- BS-EN-12564 - Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants
- BS-EN-14299 - Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents
- BS-EN-45502-1 - Implants for surgery. Active implantable medical devices
- BS-EN-45502-1-TC - Tracked Changes. Implants for surgery. Active implantable medical devices
- BS-EN-45502-2-1 - Active implantable medical devices
- BS-EN-45502-2-2 - Active implantable medical devices
- BS-EN-45502-2-3 - Active implantable medical devices
- BS-EN-50527-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-50527-1-TC - Tracked Changes. Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-50527-2-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-50527-2-1-TC - Tracked Changes. Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-50527-2-2 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-50527-2-3 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices
- BS-EN-60601-2-31 - Medical electrical equipment
- BS-EN-IEC-60601-2-31 - Medical electrical equipment
- BS-EN-ISO-10328 - Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
- BS-EN-ISO-10328-TC - Tracked Changes. Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
- BS-EN-ISO-12417-1 - Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
- BS-EN-ISO-13356 - Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- BS-EN-ISO-13356-TC - Tracked Changes. Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- BS-EN-ISO-13958 - Concentrates for haemodialysis and related therapies
- BS-EN-ISO-13959 - Water for haemodialysis and related therapies
- BS-EN-ISO-14602 - Non-active surgical implants. Implants for osteosynthesis. Particular requirements
- BS-EN-ISO-14607 - Non-active surgical implants. Mammary implants. Particular requirements
- BS-EN-ISO-14630 - Non-active surgical implants. General requirements
- BS-EN-ISO-14708-2 - Implants for surgery. Active implantable medical devices
- BS-EN-ISO-14708-3 - Implants for surgery. Active implantable medical devices
- BS-EN-ISO-14708-4 - Implants for surgery. Active implantable medical devices.
- BS-EN-ISO-14708-5 - Implants for surgery. Active implantable medical devices
- BS-EN-ISO-14708-6 - Implants for surgery. Active implantable medical devices
- BS-EN-ISO-14708-7 - Implants for surgery. Active implantable medical devices
- BS-EN-ISO-16054 - Implants for surgery. Minimum data sets for surgical implants
- BS-EN-ISO-16061 - Instruments for use in association with non-active surgical implants. General requirements
- BS-EN-ISO-16061-TC - Tracked Changes. Instruments for use in association with non-active surgical implants. General requirements
- BS-EN-ISO-21534 - Non-active surgical implants. Joint replacement implants. Particular requirements
- BS-EN-ISO-21535 - Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
- BS-EN-ISO-21535-TC - Tracked Changes. Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
- BS-EN-ISO-21536 - Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
- BS-EN-ISO-21536-TC - Tracked Changes. Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
- BS-EN-ISO-22523 - External limb prostheses and external orthoses. Requirements and test methods
- BS-EN-ISO-22675 - Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
- BS-EN-ISO-22675-TC - Tracked Changes. Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
- BS-EN-ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-1-TC - Tracked Changes. Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-2 - Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-2-TC - Tracked Changes. Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-3 - Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-3-TC - Tracked Changes. Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-4 - Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-5 - Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-23500-5-TC - Tracked Changes. Preparation and quality management of fluids for haemodialysis and related therapies
- BS-EN-ISO-25539-1 - Cardiovascular implants. Endovascular devices
- BS-EN-ISO-25539-2 - Cardiovascular implants. Endovascular devices
- BS-EN-ISO-25539-3 - Cardiovascular implants. Endovascular devices
- BS-EN-ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies
- BS-EN-ISO-5832-1-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-EN-ISO-5832-2 - Implants for surgery. Metallic materials
- BS-EN-ISO-5832-2-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-EN-ISO-5832-3 - Implants for surgery. Metallic materials
- BS-EN-ISO-5832-3-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-EN-ISO-5832-6 - Implants for surgery. Metallic materials
- BS-EN-ISO-5832-7 - Implants for surgery. Metallic materials
- BS-EN-ISO-5832-7-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-EN-ISO-5840 - Cardiovascular implants. Cardiac valve prostheses
- BS-EN-ISO-5840-1 - Cardiovascular implants. Cardiac valve prostheses
- BS-EN-ISO-5840-2 - Cardiovascular implants. Cardiac valve prostheses
- BS-EN-ISO-5840-2-TC - Tracked Changes. Cardiovascular implants. Cardiac valve prostheses
- BS-EN-ISO-5840-3 - Cardiovascular implants. Cardiac valve prostheses
- BS-EN-ISO-7197 - Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
- BS-EN-ISO-7198 - Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
- BS-EN-ISO-7199 - Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
- BS-EN-ISO-7199-TC - Tracked Changes. Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
- BS-EN-ISO-8637 - Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- BS-EN-ISO-8637-1 - Extracorporeal systems for blood purification
- BS-EN-ISO-8637-2 - Extracorporeal systems for blood purification
- BS-EN-ISO-8637-2-TC - Tracked Changes. Extracorporeal systems for blood purification
- BS-EN-ISO-8638 - Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- BS-EN-ISO-9713 - Neurosurgical implants. Self-closing intracranial aneurysm clips
- BS-EN-ISO-9713-TC - Tracked Changes. Neurosurgical implants. Self-closing intracranial aneurysm clips
- BS-ISO-10328-1 - Prosthetics. Structural testing of lower-limb prostheses
- BS-ISO-10328-2 - Prosthetics. Structural testing of lower-limb prostheses
- BS-ISO-10328-3 - Principal Structural Tests
- BS-ISO-11318 - Cardiac defibrillators. Connector assembly DF-1 for implantable defibrillators. Dimensions and test requirements
- BS-ISO-11491 - Implants for surgery. Determination of impact resistance of ceramic femoral heads for hip joint prostheses
- BS-ISO-11658 - Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems
- BS-ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies
- BS-ISO-12891-1 - Retrieval and analysis of surgical implants
- BS-ISO-12891-1-TC - Tracked Changes. Retrieval and analysis of surgical implants
- BS-ISO-13175-3 - Implants for surgery. Calcium phosphates
- BS-ISO-13179-1 - Implants for surgery. Coatings on metallic surgical implants
- BS-ISO-13179-1-TC - Tracked Changes. Implants for surgery. Coatings on metallic surgical implants
- BS-ISO-13356 - Implants for Surgery, Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia
- BS-ISO-13404 - Prosthetics and orthotics. Categorization and description of external orthoses and orthotic components
- BS-ISO-13405-1 - Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13405-1-TC - Tracked Changes. Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13405-2 - Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13405-2-TC - Tracked Changes. Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13405-3 - Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13405-3-TC - Tracked Changes. Prosthetics and orthotics. Classification and description of prosthetic components
- BS-ISO-13779-1 - Implants for surgery. Hydroxyapatite
- BS-ISO-13779-2 - Implants for surgery. Hydroxyapatite
- BS-ISO-13779-2-TC - Tracked Changes. Implants for surgery. Hydroxyapatite
- BS-ISO-13779-3 - Implants for surgery. Hydroxyapatite
- BS-ISO-13779-3-TC - Tracked Changes. Implants for surgery. Hydroxyapatite
- BS-ISO-13779-4 - Implants for surgery. Hydroxyapatite
- BS-ISO-13779-4-TC - Tracked Changes. Implants for surgery. Hydroxyapatite
- BS-ISO-13781 - Implants for surgery. Homopolymers, copolymers and blends on poly(lactide). In vitro degradation testing
- BS-ISO-13782 - Implants for surgery. Metallic materials. Unalloyed tantalum for surgical implant applications
- BS-ISO-13959 - Water for haemodialysis and related therapies
- BS-ISO-14117 - Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- BS-ISO-14242-1 - Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14242-2 - Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14242-2-TC - Tracked Changes. Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14242-3 - Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14242-3-TC - Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14242-4 - Implants for surgery. Wear of total hip-joint prostheses
- BS-ISO-14243-1 - Implants for surgery. Wear of total knee-joint prostheses
- BS-ISO-14243-2 - Implants for surgery. Wear of total knee-joint prostheses
- BS-ISO-14243-2-TC - Tracked Changes. Implants for surgery. Wear of total knee-joint prostheses
- BS-ISO-14243-3 - Implants for surgery. Wear of total knee-joint prostheses
- BS-ISO-14243-5 - Implants for surgery. Wear of total knee prostheses
- BS-ISO-14879-1 - Implants for surgery. Total kneejoint prostheses
- BS-ISO-14949 - Implants for surgery. Two-part addition-cure silicone elastomers
- BS-ISO-15032 - Prostheses. Structural testing of hip joints
- BS-ISO-15309 - Implants for surgery. Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
- BS-ISO-15674 - Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
- BS-ISO-15675 - Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
- BS-ISO-15676 - Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
- BS-ISO-16087 - Implants for surgery. Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
- BS-ISO-16428 - Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
- BS-ISO-17327-1 - Non-active surgical implants. Implant coating
- BS-ISO-17853 - Wear of implant materials. Polymer and metal wear particles. Isolation and characterization
- BS-ISO-18192-1 - Implants for surgery. Wear of total intervertebral spinal disc prostheses
- BS-ISO-18192-2 - Implants for surgery. Wear of total intervertebral spinal disc prostheses
- BS-ISO-18192-3 - Implants for surgery. Wear of total intervertebral spinal disc prostheses
- BS-ISO-18193 - Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation
- BS-ISO-18241 - Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps
- BS-ISO-18242 - Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps
- BS-ISO-19090 - Tissue-engineered medical products. Bioactive ceramics. Method to measure cell migration in porous materials
- BS-ISO-19213 - Implants for surgery. Test methods of material for use as a cortical bone model
- BS-ISO-19227 - Implants for surgery. Cleanliness of orthopedic implants. General requirements
- BS-ISO-19233-1 - Implants for surgery. Orthopaedic joint prosthesis
- BS-ISO-20069 - Guidance for assessment and evaluation of changes to drug delivery systems
- BS-ISO-21063 - Prosthetics and orthotics. Soft orthoses. Uses, functions, classification and description
- BS-ISO-21064 - Prosthetics and orthotics. Foot orthotics. Uses, functions classification and description
- BS-ISO-21065 - Prosthetics and orthotics. Terms relating to the treatment and rehabilitation of persons having a lower limb amputation
- BS-ISO-212063 - Prosthetics and orthotics. Soft orthoses. Uses, functions, classification and description
- BS-ISO-21917 - Anaesthetic and respiratory equipment. Voice prostheses
- BS-ISO-22622 - Implants for surgery. Wear of total ankle-joint prostheses. Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
- BS-ISO-22679 - Cardiovascular implants. Transcatheter cardiac occluders
- BS-ISO-22926 - Implants for surgery. Specification and verification of synthetic anatomical bone models for testing
- BS-ISO-23317 - Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials
- BS-ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
- BS-ISO-25539-4 - Cardiovascular implants. Endovascular devices
- BS-ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies
- BS-ISO-27185 - Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements
- BS-ISO-27186 - Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
- BS-ISO-29781 - Prostheses and orthoses. Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth
- BS-ISO-29782 - Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
- BS-ISO-29782-TC - Tracked Changes. Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
- BS-ISO-29783-1 - Prosthetics and orthotics. Vocabulary
- BS-ISO-29783-2 - Prosthetics and orthotics. Vocabulary
- BS-ISO-29783-3 - Prosthetics and orthotics. Vocabulary
- BS-ISO-5832-1 - Implants for surgery. Metallic materials
- BS-ISO-5832-11 - Implants for surgery. Metallic materials
- BS-ISO-5832-11-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-ISO-5832-12 - Implants for surgery. Metallic materials
- BS-ISO-5832-14 - Implants for surgery. Metallic materials
- BS-ISO-5832-2 - Part 2: Unalloyed Titanium
- BS-ISO-5832-4 - Implants for surgery. Metallic materials
- BS-ISO-5832-4-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-ISO-5832-5 - Implants for surgery. Metallic materials
- BS-ISO-5832-5-TC - Tracked Changes. Implants for surgery. Metallic materials
- BS-ISO-5832-7 - Implants for surgery. Metallic materials
- BS-ISO-5832-9 - Implants for surgery. Metallic materials
- BS-ISO-5833 - Implants for surgery. Acrylic resin cements
- BS-ISO-5834-1 - Implants for surgery. Ultra-high-molecular-weight polyethylene
- BS-ISO-5834-2 - Implants for surgery. Ultra-high-molecular-weight polyethylene
- BS-ISO-5834-3 - Implants for surgery. Ultra-high-molecular-weight polyethylene
- BS-ISO-5834-4 - Implants for surgery. Ultra-high-molecular-weight polyethylene
- BS-ISO-5834-5 - Implants for surgery. Ultra-high-molecular-weight polyethylene
- BS-ISO-5838-1 - Implants for surgery. Metallic skeletal pins and wires
- BS-ISO-5841-2 - Implants for surgery. Cardiac pacemakers
- BS-ISO-5910 - Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices
- BS-ISO-6474-1 - Implants for surgery. Ceramic materials
- BS-ISO-6474-2 - Implants for surgery. Ceramic materials
- BS-ISO-7198 - Cardiovascular implants. Tubular vascular prostheses
- BS-ISO-7199 - Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
- BS-ISO-7206-1 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7206-10-TC - Tracked Changes. Implants for surgery. Partial and total hip-joint prostheses
- BS-ISO-7206-12 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7206-13 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7206-2 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7206-4 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7206-6 - Implants for surgery. Partial and total hip joint prostheses
- BS-ISO-7207-1 - Implants for surgery. Components for partial and total knee joint prostheses
- BS-ISO-7207-2 - Implants for surgery. Components for partial and total knee joint prostheses
- BS-ISO-8548-2 - Prosthetics and orthotics. Limb deficiencies
- BS-ISO-8548-4 - Prosthetics and orthotics. Limb deficiencies
- BS-ISO-8548-5 - Prosthetics and orthotics. Limb deficiencies
- BS-ISO-8549-1 - Prosthetics and orthotics. Vocabulary
- BS-ISO-8549-2 - Prosthetics and orthotics. Vocabulary
- BS-ISO-8549-2-TC - Tracked Changes. Prosthetics and orthotics. Vocabulary
- BS-ISO-8549-3 - Prosthetics and orthotics. Vocabulary
- BS-ISO-8549-4 - Prosthetics and orthotics. Vocabulary
- BS-ISO-8551 - Prosthetics and orthotics. Functional deficiencies. Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis
- BS-ISO-8637-3 - Extracorporeal systems for blood purification
- BS-ISO-8637-3-TC - Tracked Changes. Extracorporeal systems for blood purification
- BS-ISO-8828 - Implants for surgery. Guidance on care and handling of orthopaedic implants
- BS-ISO-9584 - Implants for surgery. Non-destructive testing. Radiographic examination of cast metallic surgical implants
- BS-ISO-9584-TC - Tracked Changes. Implants for surgery. Non-destructive testing. Radiographic examination of cast metallic surgical implants
- BS-ISO-9714-1 - Orthopaedic drilling instruments
- DD-ISO-12417 - Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
- PD-ISO-10974 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
- PD-ISO-10974-TC - Tracked Changes. Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
- PD-ISO-12417-2 - Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
- PD-ISO-16379 - Tissue-engineered medical products. Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging
- PD-ISO-16955 - Prosthetics. Quantification of physical parameters of ankle foot devices and foot units
- PD-ISO-17137 - Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
- PD-ISO-17137-TC - Tracked Changes. Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
- PD-ISO-17327-2 - Non-active surgical implants. Implant coating
- PD-ISO-19024 - Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
- PD-ISO-20721 - Implants for surgery. General guidelines and requirements for assessment of absorbable metallic implants
- PD-ISO-21560 - General requirements of tissue-engineered medical products
- PD-ISO-21900 - Guidance for uncertainty analysis regarding the application of ISO/TS 10974
- PD-ISO-24560-1 - Tissue-engineered medical products. MRI evaluation of cartilage
- PD-ISO-37137 - Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
- PD-ISO-37137-1 - Biological evaluation of absorbable medical devices
- PD-ISO-4549 - Orthotics. Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses
- PD-ISO/PAS-7020 - Sizing parameters of surgical valve prostheses. Requirements regarding the application of ISO 5840-2
ISO:
- ISO-10310 - Neurosurgical implants -- Marking and packaging of implantable neural stimulators
- ISO-10328 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
- ISO-10328-1 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 1: Test configurations
- ISO-10328-2 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 2: Test samples
- ISO-10328-3 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 3: Principal structural tests
- ISO-10328-4 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 4: Loading parameters of principal structural tests
- ISO-10328-5 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 5: Supplementary structural tests
- ISO-10328-6 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 6: Loading parameters of supplementary structural tests
- ISO-10328-7 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 7: Test submission document
- ISO-10328-8 - Prosthetics -- Structural testing of lower-limb prostheses -- Part 8: Test report
- ISO-10334 - Implants for surgery -- Malleable wires for use as sutures and other surgical applications
- ISO-10974 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
- ISO-11318 - Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements
- ISO-11318-1 - Amendment 1, Cardiac Defibrillators - Connector Assembly Forimplantable Defibrillators -
- ISO-11491 - Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
- ISO-11658 - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
- ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies
- ISO-12189 - Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support
- ISO-12417 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
- ISO-12417-1 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
- ISO-12417-2 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information
- ISO-12891-1 - Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
- ISO-12891-2 - Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants
- ISO-12891-3 - Retrieval and analysis of surgical implants - Part 3: Analysis of retrieved polymeric surgical implants
- ISO-12891-4 - Retrieval and analysis of surgical implants -- Part 4: Analysis of retrieved ceramic surgical implants
- ISO-13019 - Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
- ISO-13175-3 - Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
- ISO-13179-1 - Implants for surgery - Coatings on metallic surgical implants - Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
- ISO-13356 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
- ISO-13404 - Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
- ISO-13404-1 - Prosthetics and orthotics - External orthoses and orthotic components - Part 1: Uses, functions, classification and description of lower limb orthoses
- ISO-13405-1 - Prosthetics and orthotics - Classification and description of prosthetic components - Part 1: Classification of prosthetic components
- ISO-13405-2 - Prosthetics and orthotics - Classification and description of prosthetic components - Part 2: Description of lower limb prosthetic components
- ISO-13405-3 - Prosthetics and orthotics - Classification and description of prosthetic components - Part 3: Description of upper limb prosthetic components
- ISO-13779-1 - Implants for surgery - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
- ISO-13779-2 - Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
- ISO-13779-3 - Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
- ISO-13779-3-AM1 - - Amendment 1
- ISO-13779-4 - Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
- ISO-13779-6 - Implants for surgery - Hydroxyapatite - Part 6: Powders
- ISO-13781 - Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
- ISO-13782 - Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
- ISO-13958 - Concentrates for haemodialysis and related therapies
- ISO-13959 - Water for haemodialysis and related therapies
- ISO-13960 - Cardiovascular implants and extracorporeal systems - Plasmafilters
- ISO-14117 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- ISO-14242-1 - Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
- ISO-14242-1-AM1 - - Amendment 1
- ISO-14242-2 - Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
- ISO-14242-3 - Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
- ISO-14242-3-AM1 - - Amendment 1
- ISO-14242-4 - Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
- ISO-14243-1 - Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
- ISO-14243-1-AM1 - - Amendment 1
- ISO-14243-2 - Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
- ISO-14243-3 - Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
- ISO-14243-3-AM1 - - Amendment 1
- ISO-14243-5 - Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
- ISO-14283 - Implants for surgery - Essential principles of safety and performance
- ISO-14602 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements
- ISO-14607 - Non-active surgical implants - Mammary implants - Specific requirements
- ISO-14630 - Non-active surgical implants - General requirements
- ISO-14708-1 - Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
- ISO-14708-2 - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
- ISO-14708-3 - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
- ISO-14708-4 - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems
- ISO-14708-5 - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
- ISO-14708-6 - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- ISO-14708-7 - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
- ISO-14879-1 - Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
- ISO-14949 - Implants for surgery - Two-part addition-cure silicone elastomers
- ISO-15032 - Prostheses -- Structural testing of hip units
- ISO-15142-1 - Implants for surgery -- Metal intramedullary nailing systems -- Part 1: Intramedullary nails
- ISO-15142-2 - Implants for surgery -- Metal intramedullary nailing systems -- Part 2: Locking components
- ISO-15142-3 - Implants for surgery -- Metal intramedullary nailing systems -- Part 3: Connection devices and reamer diameter measurements
- ISO-15309 - Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
- ISO-15374 - Implants for surgery -- Requirements for production of forgings
- ISO-15539 - Cardiovascular implants -- Endovascular prostheses
- ISO-15674 - Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
- ISO-15674-AM1 - - Amendment 1: Connectors
- ISO-15675 - Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
- ISO-15676 - Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
- ISO-15814 - Implants for surgery -- Copolymers and blends based on polylactide -- In vitro degradation testing
- ISO-16054 - Implants for surgery - Minimum data sets for surgical implants
- ISO-16061 - Instruments for use in association with non-active surgical implants - General requirements
- ISO-16061-RL - Instrumentation for use in association with non-active surgical implants - General requirements (includes Redline Version)
- ISO-16087 - Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
- ISO-16379 - Tissue-engineered medical products - Evaluation of anisotropic structure of articular cartilage using DT (Diffusion Tensor)-MR Imaging
- ISO-16402 - Implants for surgery - Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics
- ISO-16428 - Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
- ISO-16429 - Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
- ISO-16955 - Prosthetics - Quantification of physical parameters of ankle foot devices and foot units
- ISO-17137 - Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
- ISO-17327-1 - Non-active surgical implants - Implant coating - Part 1: General requirements
- ISO-17327-2 - Non-active surgical implants - Implant coating - Part 2: Reference standards related to coatings
- ISO-17853 - Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
- ISO-18192-1 - Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
- ISO-18192-1-AM1 - - Amendment 1
- ISO-18192-2 - Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
- ISO-18192-3 - Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
- ISO-18193 - Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
- ISO-18241 - Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
- ISO-18241-AM1 - - Amendment 1: Connectors
- ISO-18242 - Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
- ISO-18242-AM1 - - Amendment 1: Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps - Amendment 1: Worst-case conditions for testing
- ISO-19024 - Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
- ISO-19090 - Tissue-engineered medical products - Bioactive ceramics - Method to measure cell migration in porous materials
- ISO-19213 - Implants for surgery - Test methods of material for use as a cortical bone model
- ISO-19227 - Implants for surgery - Cleanliness of orthopedic implants - General requirements
- ISO-19233-1 - Implants for surgery - Orthopaedic joint prosthesis - Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
- ISO-20160 - Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars
- ISO-20721 - Implants for surgery - General guidelines and requirements for assessment of absorbable metallic implants
- ISO-21063 - Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description
- ISO-21064 - Prosthetics and orthotics - Foot orthotics - Uses, functions classification and description
- ISO-21065 - Prosthetics and orthotics - Terms relating to the treatment and rehabilitation of persons having a lower limb amputation
- ISO-21534 - Non-active surgical implants - Joint replacement implants - Particular requirements
- ISO-21535 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
- ISO-21535-AM1 - - Amendment 1
- ISO-21536 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
- ISO-21536-AM1 - - Amendment 1
- ISO-21560 - General requirements of tissue-engineered medical products
- ISO-21900 - Guidance for uncertainty analysis regarding the application of ISO/TS 10974
- ISO-21917 - Anaesthetic and respiratory equipment - Voice prostheses
- ISO-22523 - External limb prostheses and external orthoses - Requirements and test methods
- ISO-22622 - Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
- ISO-22675 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
- ISO-22676 - Prosthetics - Testing of ankle-foot devices and foot units - Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
- ISO-22679 - Cardiovascular implants - Transcatheter cardiac occluders
- ISO-22926 - Implants for surgery - Specification and verification of synthetic anatomical bone models for testing
- ISO-23089-2 - Implants for surgery - Pre-clinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
- ISO-23317 - Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials
- ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
- ISO-23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements
- ISO-23500-2 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
- ISO-23500-3 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
- ISO-23500-4 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
- ISO-23500-5 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
- ISO-23810 - Cardiovascular implants and artificial organs - Checklists for use of extracorporeal circulation equipment
- ISO-24560-1 - Tissue-engineered medical products - MRI evaluation of cartilage - Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
- ISO-24562 - Prosthetics - Geometrical aspects of lower limb prosthetic adapters
- ISO-25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
- ISO-25539-1-1 - Amendment 1: Test methods
- ISO-25539-2 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
- ISO-25539-3 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
- ISO-25539-4 - Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
- ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies
- ISO-27185 - Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
- ISO-27186 - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
- ISO-29781 - Prostheses and orthoses - Factors to be included when describing physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth
- ISO-29782 - Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation
- ISO-29783-1 - Prosthetics and orthotics - Vocabulary - Part 1: Normal gait
- ISO-29783-2 - Prosthetics and orthotics - Vocabulary - Part 2: Prosthetic gait
- ISO-29783-3 - Prosthetics and orthotics - Vocabulary - Part 3: Pathological gait (excluding prosthetic gait)
- ISO-37137 - Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
- ISO-37137-1 - Biological evaluation of absorbable medical devices - Part 1: General requirements
- ISO-4549 - Orthotics - Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses
- ISO-5832-1 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
- ISO-5832-10 - Part 10: Wrought Titanium 5-Aluminium 2,5-Iron Alloy, Implants for Surgery - Metallic Mate
- ISO-5832-11 - Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- ISO-5832-12 - Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
- ISO-5832-14 - Implants for surgery - Metallic materials - Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
- ISO-5832-2 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
- ISO-5832-3 - Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- ISO-5832-4 - Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
- ISO-5832-5 - Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel
- ISO-5832-6 - Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
- ISO-5832-7 - Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
- ISO-5832-8 - Implants for surgery -- Metallic materials -- Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
- ISO-5832-9 - Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
- ISO-5833 - Implants for surgery - Acrylic resin cements
- ISO-5834-1 - Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
- ISO-5834-2 - Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
- ISO-5834-3 - Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
- ISO-5834-4 - Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
- ISO-5834-5 - Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
- ISO-5835 - Implants for surgery -- Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread -- Dimensions
- ISO-5836 - Implants for surgery -- Metal bone plates -- Holes corresponding to screws with asymmetrical thread and spherical under-surface
- ISO-5837-1 - Implants for surgery -- Intramedullary nailing systems -- Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
- ISO-5837-2 - Implants for surgery -- Intramedullary nailing systems -- Part 2: Medullary pins
- ISO-5838-1 - Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements
- ISO-5838-2 - Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
- ISO-5838-3 - Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
- ISO-5840 - Cardiovascular implants - Cardiac valve prostheses
- ISO-5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- ISO-5840-1-RL - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- ISO-5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- ISO-5840-2-RL - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- ISO-5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
- ISO-5840-3-RL - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
- ISO-5841-1 - Cardiac pacemakers -- Part 1: Implantable pacemakers
- ISO-5841-2 - Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
- ISO-5841-3 - Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
- ISO-5910 - Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
- ISO-6474 - Implants for surgery -- Ceramic materials based on high purity alumina
- ISO-6474-1 - Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
- ISO-6474-2 - Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
- ISO-6475 - Implants for surgery -- Metal bone screws with asymmetrical thread and spherical under-surface -- Mechanical requirements and test methods
- ISO-7197 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts
- ISO-7198 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
- ISO-7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- ISO-7199-AM1 - - Amendment 1: Connectors
- ISO-7206-1 - Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions
- ISO-7206-10 - Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
- ISO-7206-10-AM1 - - Amendment 1
- ISO-7206-12 - Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
- ISO-7206-13 - Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
- ISO-7206-13-AM1 - - Amendment 1: Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components - Amendment 1
- ISO-7206-2 - Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
- ISO-7206-2-AM1 - - Amendment 1
- ISO-7206-3 - Implants for surgery -- Partial and total hip joint prostheses -- Part 3: Determination of endurance properties of stemmed femoral components without application of torsion
- ISO-7206-4 - Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO-7206-4-AM1 - - Amendment 1
- ISO-7206-5 - Implants for surgery -- Partial and total hip joint prostheses -- Part 5: Determination of resistance to static load of head and neck region of stemmed femoral components
- ISO-7206-6 - Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
- ISO-7206-7 - Implants for surgery -- Partial and total hip joint prostheses -- Part 7: Endurance performance of stemmed femoral components without application of torsion
- ISO-7206-8 - Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion
- ISO-7206-9 - Implants for surgery -- Partial and total hip joint prostheses -- Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
- ISO-7207-1 - Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
- ISO-7207-2 - Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials
- ISO-7207-2-AM1 - - Amendment 1
- ISO-7207-2-AM2 - - Amendment 2
- ISO-8319-1 - Orthopaedic instruments -- Drive connections -- Part 1: Keys for use with screws with hexagon socket heads
- ISO-8319-2 - Orthopaedic instruments -- Drive connections -- Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
- ISO-8548-1 - Prosthetics and orthotics -- Limb deficiencies -- Part 1: Method of describing limb deficiencies present at birth
- ISO-8548-2 - Prosthetics and orthotics - Limb deficiencies - Part 2: Method of describing lower limb amputation stumps
- ISO-8548-3 - Prosthetics and orthotics -- Limb deficiencies -- Part 3: Method of describing upper limb amputation stumps
- ISO-8548-4 - Prosthetics and orthotics -- Limb deficiencies -- Part 4: Description of causal conditions leading to amputation
- ISO-8548-5 - Prosthetics and orthotics - Limb deficiencies - Part 5: Description of the clinical condition of the person who has had an amputation
- ISO-8549-1 - Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses
- ISO-8549-2 - Prosthetics and orthotics - Vocabulary - Part 2: Terms relating to external limb prostheses
- ISO-8549-3 - Prosthetics and orthotics - Vocabulary - Part 3: Terms relating to orthoses
- ISO-8549-4 - Prosthetics and orthotics - Vocabulary - Part 4: Terms relating to limb amputation
- ISO-8551 - Prosthetics and orthotics - Functional deficiencies - Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis
- ISO-8615 - Implants for surgery -- Fixation devices for use in the ends of the femur in adults
- ISO-8637 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ISO-8637-1 - Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ISO-8637-2 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
- ISO-8637-3 - Extracorporeal systems for blood purification - Part 3: Plasmafilters
- ISO-8637-AM1 - - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
- ISO-8638 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- ISO-8827 - Implants for surgery -- Staples with parallel legs for orthopaedic use -- General requirements
- ISO-8828 - Implants for surgery - Guidance on care and handling of orthopaedic implants
- ISO-9268 - Implants for surgery -- Metal bone screws with conical under-surface of head -- Dimensions
- ISO-9269 - Implants for surgery -- Metal bone plates -- Holes and slots corresponding to screws with conical under-surface
- ISO-9325 - Implants for surgery -- Partial and total hip joint prostheses -- Recommendations for simulators for evaluation of hip joint prostheses
- ISO-9326 - Implants for surgery -- Partial and total hip joint prostheses -- Guidance for laboratory evaluation of change of form of bearing surfaces
- ISO-9583 - Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
- ISO-9584 - Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants
- ISO-9585 - Implants for surgery -- Determination of bending strength and stiffness of bone plates
- ISO-9586 - Implants for surgery -- Usage of terms valgus and varus in orthopaedic surgery
- ISO-9713 - Neurosurgical implants - Self-closing intracranial aneurysm clips
- ISO-9714-1 - Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters
- ISO/DIS-13960 - Cardiovascular Implants & Artificial Organs - Plasmafilters
- ISO/DIS-18192-1 - Part 1: Loading and Displacement Parameters for Wear Testing and Corresponding Environment
- ISO/DIS-19227 - Implants for surgery - Cleanliness of orthopedic implants - General requirements
- ISO/DIS-21535 - Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements For
- ISO/DIS-27186 - Active Implantable Medical Devices - Four-Pole Connector System for Implantable Cardia
- ISO/DIS-5832-5 - Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy, Implants for Surgery - Metallic Mat
- ISO/DIS-5910 - Cardiovascular implants and extracorporeal systems -- Cardiac valve repair devices
- ISO/PAS-7020 - Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
Other SDOs:
- AAMI/ISO-25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
- AAMI/ISO-TIR-12417 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
- AAMI/ISO-TIR37137 - Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
- ANSI/AAMI/ISO-11663 - Quality of dialysis fluid for hemodialysis and related therapies
- ANSI/AAMI/ISO-13958 - Concentrates for hemodialysis and related therapies
- ANSI/AAMI/ISO-13959 - Water for hemodialysis and related therapies
- ANSI/AAMI/ISO-23500 - Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
- ANSI/AAMI/ISO-255391 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
- ANSI/AAMI/ISO25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, Amendment 1: Test methods
- ANSI/AAMI/ISO-26722 - Water treatment equipment for hemodialysis applications and related therapies
- ANSI/AAMI/ISO-27185 - Active implantable medical devices - Symbols to be used with cardiac device labels, labeling and information to be supplied by the manufacturer (ANSI/AAMI/ISO 27185:2012)
- ANSI/AAMI/ISO-27186 - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
- ANSI/AAMI/ISO-5840 - Cardiovascular implants -- Cardiac valve prostheses
- ANSI/AAMI/ISO-5840-1 - Cardiovascular implants-Cardiac valve prostheses - Part 1: General requirements
- ANSI/AAMI/ISO-5840-2 - Cardiovascular implants-Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- ANSI/AAMI/ISO-5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
- ANSI/AAMI/ISO-5841-2 - Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
- ANSI/AAMI/ISO-5841-3 - Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
- ANSI/AAMI/ISO-7198 - Cardiovascular implants - Tubular vascular prostheses
- ANSI/AAMI/ISO-7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- ANSI/AAMI/ISO-8637 - Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
- ANSI/AAMI/ISO-8638 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilter
- BS-ISO-5910-TC - Tracked Changes. Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices
- DIN-EN-14299 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents; German version EN 14299:2004
- DIN-EN-ISO-14607 - Non-Active Surgical Implants - Mammary Implants - Particular Requirements
- DIN-EN-ISO-14630 - Non-active surgical implants - General requirements (ISO 14630:2012)
- DIN-EN-ISO-5840 - Cardiovascular implants - Cardiac valve prostheses
- DIN-EN-ISO-7197 - Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts & Components
- DIN-EN-ISO-9713 - Neurosurgical Implants - Self-Closing Intracranial Aneurysm Clips
- DIN-ISO-5834-1 - Part 1: Powder Form, Implants for Surgery - Ultra-High Molecular-Weight Polyethylene
- EN-12006-2 - Part 2: Vascular Prostheses Including Cardiac Valve Conduits, Non Active Surgical Impl
- EN-14790 - Stationary source emissions - Determination of the water vapour in ducts - Standard reference method
- EN-45502-2-2 - Active Implantable Medical Devices, Particular Requirements for Active Implantable Me
- EN-45502-2-3 - Part 2-3: Particular Requirements for Cochlear Implant Systems, Active Implantable Med
- EN-50527-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
- EN-50527-2-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
- EN-50527-2-2 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
- EN-ISO-10328 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
- EN-ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies
- EN-ISO-12417-1 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
- EN-ISO-13356 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia
- EN-ISO-13958 - Concentrates for haemodialysis and related therapies
- EN-ISO-13959 - Water for haemodialysis and related therapies
- EN-ISO-14602 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements
- EN-ISO-14607 - Non-Active Surgical Implants, Mammary Implants, Particular Requirements
- EN-ISO-14630 - Non-active surgical implants - General requirements (ISO 14630:2012)
- EN-ISO-15001 - Anaesthetic and respiratory equipment - Compatibility with oxygen
- EN-ISO-16061 - Instrumentation for use in association with non-active surgical implants - General requirements
- EN-ISO-21534 - Non-Active Surgical Implants, Joint Replacement Implants, Particular Requirements
- EN-ISO-21535 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1
- EN-ISO-21536 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
- EN-ISO-22523 - External Limb Prostheses & External Orthoses - Requirements & Test Methods
- EN-ISO-22675 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods
- EN-ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
- EN-ISO-23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
- EN-ISO-23500-2 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
- EN-ISO-23500-3 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
- EN-ISO-23500-4 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
- EN-ISO-23500-5 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
- EN-ISO-25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
- EN-ISO-25539-2 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
- EN-ISO-25539-3 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
- EN-ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies
- EN-ISO-5832-3 - Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- EN-ISO-5840 - Cardiovascular Implants, Cardiac Valve Prostheses
- EN-ISO-5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- EN-ISO-5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- EN-ISO-5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
- EN-ISO-7197 - Neurosurgical Implants, Sterile, Single-Use Hydrocephalus Shunts & Components
- EN-ISO-7198 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
- EN-ISO-7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
- EN-ISO-8637 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
- EN-ISO-8637-2 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- EN-ISO-8638 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
- EN-ISO-9713 - Neurosurgical Implants, Self-Closing Intracranial Aneurysm Clips
- ISO-15675-AM1 - - Amendment 1: Connectors
- JIS-T-0112 - Prostheses -- Structural testing of hip units
- JIS-T-3231 - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
- JIS-T-3232 - Blood filters for cardiopulmonary bypass systems
- JIS-T-3248 - Extracorporeal blood circuit
- JIS-T-7401-4 - Titanium materials for surgical implant applications Part 4: Wrought titanium 15-zirconium 4-niobium 4-tantalum alloy
- SAE-J3020 - Medical Device Shot Peening
- SIS-CEN/TS-15277 - Non-active surgical implants - Injectable implants
- SS-EN-12006-1 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
- SS-EN-12006-2 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
- SS-EN-12006-3 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
- SS-EN-12010 - Water quality - Determination of short-chain polychlorinated alkanes (SCCPs) in water - Method using gas chromatography-mass spectrometry (GC-MS) and negative-ion chemical ionization (NCI) (ISO 12010:2012)
- SS-EN-12180 - Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants
- SS-EN-12563 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants
- SS-EN-12564 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants
- SS-EN-13480 - Metallic industrial piping
- SS-EN-14299 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
- SS-EN-45502-1 - Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
- SS-EN-45502-2-1 - Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhytmia (cardiac pacemakers)
- SS-EN-45502-2-2 - Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (Includes implantable defibrillators)
- SS-EN-ISO-10328 - Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
- SS-EN-ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
- SS-EN-ISO-12417-1 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
- SS-EN-ISO-13356 - Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
- SS-EN-ISO-13958 - Concentrates for haemodialysis and related therapies (ISO 13958:2014)
- SS-EN-ISO-13959 - Water for haemodialysis and related therapies (ISO 13959:2014)
- SS-EN-ISO-14602 - Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
- SS-EN-ISO-14607 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018)
- SS-EN-ISO-14630 - Non-active surgical implants - General requirements (ISO 14630:2012)
- SS-EN-ISO-14708-2 - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
- SS-EN-ISO-14708-3 - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
- SS-EN-ISO-14708-4 - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
- SS-EN-ISO-14708-5 - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
- SS-EN-ISO-14708-6 - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
- SS-EN-ISO-14708-7 - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
- SS-EN-ISO-15001 - Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
- SS-EN-ISO-16054 - Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
- SS-EN-ISO-16061 - Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
- SS-EN-ISO-21534 - Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
- SS-EN-ISO-21535 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
- SS-EN-ISO-21535-AM1 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
- SS-EN-ISO-21536 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
- SS-EN-ISO-21536-AM1 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
- SS-EN-ISO-21917 - Anaesthetic and respiratory equipment - Voice prostheses(ISO 21917:2021)
- SS-EN-ISO-22523 - External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
- SS-EN-ISO-22675 - Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
- SS-EN-ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
- SS-EN-ISO-23500-1 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
- SS-EN-ISO-23500-2 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
- SS-EN-ISO-23500-3 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
- SS-EN-ISO-23500-4 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
- SS-EN-ISO-23500-5 - Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
- SS-EN-ISO-25539-1 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
- SS-EN-ISO-25539-2 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
- SS-EN-ISO-25539-3 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
- SS-EN-ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)
- SS-EN-ISO-5832-1 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
- SS-EN-ISO-5832-2 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
- SS-EN-ISO-5832-3 - Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
- SS-EN-ISO-5832-6 - Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)
- SS-EN-ISO-5832-7 - Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
- SS-EN-ISO-5840 - Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
- SS-EN-ISO-5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
- SS-EN-ISO-5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
- SS-EN-ISO-5840-3 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
- SS-EN-ISO-7197 - Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
- SS-EN-ISO-7198 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
- SS-EN-ISO-7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
- SS-EN-ISO-7439 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)
- SS-EN-ISO-8637 - Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
- SS-EN-ISO-8637-2 - Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
- SS-EN-ISO-8638 - Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
- SS-EN-ISO-9713 - Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022)
- SS-ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014, IDT)
- SS-ISO-13958 - Concentrates for haemodialysis and related therapies (ISO 13958:2014, IDT)
- SS-ISO-13959 - Water for haemodialysis and related therapies (ISO 13959:2014, IDT)
- SS-ISO-23500 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014, IDT)
- SS-ISO-26722 - Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014, IDT)
- SS-ISO-5832-14 - Implants for surgery - Metallic materials - Part 14: Wrought titanium, 15-molybdenum, 5-zirconium 3-aluminium alloy (ISO 5832-14:2007, IDT)
- UNE-EN-60601-2-66 - Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
- UNE-EN-ISO-11663 - Quality of dialysis fluid for haemodialysis and related therapies
- UNE-EN-ISO-12417-1 - Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
- UNE-EN-ISO-5840-1 - Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- UNE-EN-ISO-5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes