Document Center List of Standards on Medical Equipment In General
ICS Code 11.040.01
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-E3173 - Standard Guide for Decommissioning and Disposal of Medical Equipment
- ASTM-F1251 - Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
- ASTM-F1839 - Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- ASTM-F1984 - Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
- ASTM-F2210 - Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products (Withdrawn 2015)
- ASTM-F2211 - Standard Classification for Tissue Engineered Medical Products (TEMPs)
- ASTM-F2503 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ASTM-F2809 - Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
- ASTM-F2901 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
- ASTM-F3208 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
- ASTM-F3275 - Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
- ASTM-F3276 - Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
- ASTM-F3293 - Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
- ASTM-F3357 - Standard Guide for Designing Reusable Medical Devices for Cleanability
- ASTM-F988 - Guide for Specifying Carbon-Fiber Randomly Reinforced Ultra-High-Molecular-Weight Polyethylene for Medical Devices (Withdrawn 1992)
BSI:
- BIP-0115 - Implementing an ISO 13485 Quality Management System for Medical Devices
- BIP-2071 - Medical devices: ISO 13485 and ISO 9001
- BIP-3083 - Graphical symbols for use in the labelling of medical devices CD-ROM
- BS-7139 - Guide to graphical symbols for use on medical electrical equipment
- BS-EN-1041 - Information supplied by the manufacturer of medical devices
- BS-EN-13718-1 - Medical vehicles and their equipment. Air ambulances
- BS-EN-13718-2 - Medical vehicles and their equipment. Air ambulances
- BS-EN-1441 - Medical devices. Risk analysis
- BS-EN-15986 - Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
- BS-EN-30993-1 - Biological evaluation of medical devices
- BS-EN-30993-3 - Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- BS-EN-30993-4 - Biological evaluation of medical devices. Selection of tests for interactions with blood
- BS-EN-30993-5 - Biological evaluation of medical devices. Tests for cytotoxicity, in vitro methods
- BS-EN-30993-6 - Biological evaluation of medical devices
- BS-EN-46003 - Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003
- BS-EN-50103 - Guidance on the Application of En 29001 & En 46001 & of En 29002 & En 46002 for the Active
- BS-EN-60601-1 - Medical electrical equipment
- BS-EN-60601-1-1 - Medical electrical equipment. General requirements for safety
- BS-EN-60601-1-11 - Medical electrical equipment
- BS-EN-60601-1-11-TC - Tracked Changes. Medical electrical equipment
- BS-EN-60601-1-2 - Medical electrical equipment
- BS-EN-60601-1-4 - Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electrical medical systems
- BS-EN-60601-1-6 - Medical electrical equipment
- BS-EN-60601-1-8 - Medical electrical equipment
- BS-EN-60601-1-9 - Medical electrical equipment
- BS-EN-60601-2-31 - Medical electrical equipment
- BS-EN-60601-2-36-TC - Tracked Changes. Medical electrical equipment
- BS-EN-60601-2-49 - Medical electrical equipment
- BS-EN-60601-2-62 - Medical electrical equipment
- BS-EN-62304 - Medical device software. Software life-cycle processes
- BS-EN-62353 - Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
- BS-EN-62366 - Medical devices. Application of usability engineering to medical devices
- BS-EN-62366-1 - Medical devices
- BS-EN-793 - Particular requirements for safety of medical supply units
- BS-EN-80001-1 - Application of risk management for IT-networks incorporating medical devices
- BS-EN-80601-2-35 - Medical electrical equipment
- BS-EN-80601-2-60 - Medical electrical equipment
- BS-EN-980 - Symbols for use in the labelling of medical devices
- BS-EN-IEC-60332-3-25 - Tests on electric and optical fibre cables under fire conditions
- BS-EN-IEC-60332-3-25-TC - Tracked Changes. Tests on electric and optical fibre cables under fire conditions
- BS-EN-IEC-60601-2-31 - Medical electrical equipment
- BS-EN-IEC-60601-2-35 - Medical electrical equipment
- BS-EN-IEC-60601-2-35-TC - Tracked Changes. Medical electrical equipment
- BS-EN-IEC-60601-2-75 - Medical Electrical Equipment
- BS-EN-IEC-60601-2-76 - Medical electrical equipment
- BS-EN-IEC-80001-1 - Application of risk management for IT-networks incorporating medical devices
- BS-EN-IEC-80001-1-TC - Tracked Changes. Application of risk management for IT-networks incorporating medical devices
- BS-EN-IEC-80601-2-26 - Medical electrical equipment
- BS-EN-IEC-80601-2-30 - Medical electrical equipment
- BS-EN-IEC-80601-2-60 - Medical electrical equipment
- BS-EN-IEC-80601-2-60-TC - Tracked Changes. Medical electrical equipment
- BS-EN-IEC-80601-2-78 - Medical electrical equipment
- BS-EN-IEC-81001-5-1 - Health software and health IT systems safety, effectiveness and security
- BS-EN-ISO-10993-8 - Biological evaluation of medical devices
- BS-EN-ISO-13485 - Medical devices. Quality management systems. Requirements for regulatory purposes
- BS-EN-ISO-13488 - Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002
- BS-EN-ISO-14971 - Medical devices. Application of risk management to medical devices
- BS-EN-ISO-14971-TC - Tracked Changes. Medical devices. Application of risk management to medical devices
- BS-EN-ISO-15223-1 - Medical devices. Symbols to be used with information to be supplied by the manufacturer
- BS-EN-ISO-15223-1-CD - Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
- BS-EN-ISO-15225 - Medical devices. Quality management. Medical device nomenclature data structure
- BS-EN-ISO-15378 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- BS-EN-ISO-15378-TC - Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- BS-EN-ISO-389-1-TC - Tracked Changes. Acoustics. Reference zero for the calibration of audiometric equipment
- BS-EN-ISO-389-3 - Acoustics. Reference zero for the calibration of audiometric equipment
- BS-EN-ISO-389-3-TC - Tracked Changes. Acoustics. Reference zero for the calibration of audiometric equipment
- BS-ISO-15223-2 - Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied
- BS-ISO-15378 - Primary Packaging Materials for Medicinal Products, Particular Requirements for the Ap
- BS-ISO-16142-1 - Medical devices. Recognized essential principles of safety and performance of medical devices
- BS-ISO-16142-2 - Medical devices. Recognized essential principles of safety and performance of medical devices
- BS-ISO-17166 - Erythema reference action spectrum and standard erythema dose
- BS-ISO-20069 - Guidance for assessment and evaluation of changes to drug delivery systems
- BS-ISO-20417 - Medical devices. Information to be supplied by the manufacturer
- BS-ISO/CIE-17166 - Erythema reference action spectrum and standard erythema dose
- DD-ISO-19218 - Medical devices. Coding structure for adverse event type and cause
- DD-ISO-19218-1 - Medical devices. Hierarchical coding structure for adverse events
- PD-6630 - Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
- PD-CEN-15133 - Nomenclature. Collective terms and codes for groups of medical devices
- PD-CEN-17223 - Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
- PD-CEN-ISO-14969 - Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 (Use EN-ISO-13485)
- PD-CEN-ISO-20416 - Medical devices. Post-market surveillance for manufacturers
- PD-CEN-ISO-24971 - Medical devices. Guidance on the application of ISO 14971
- PD-CEN-ISO-24971-TC - Tracked Changes. Medical devices. Guidance on the application of ISO 14971
- PD-CR-14230 - Global medical device nomenclature for the purpose of regulatory data exchange
- PD-IEC-60601-4-1 - Medical electrical equipment
- PD-IEC-60601-4-2 - Medical electrical equipment
- PD-IEC-60601-4-2-TC - Tracked Changes. Medical electrical equipment
- PD-IEC-60601-4-4 - Medical electrical equipment
- PD-IEC-60601-4-5 - Medical electrical equipment
- PD-IEC-60601-4-6 - Medical electrical equipment
- PD-IEC-60878 - Graphical symbols for electrical equipment in medical practice
- PD-IEC-61289 - High frequency surgical equipment and high frequency surgical accessories. Operation and maintenance
- PD-IEC-62296 - Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
- PD-IEC-62354 - General testing procedures for medical electrical equipment
- PD-IEC-62366-2 - Medical devices
- PD-IEC-80001-2-1 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-2 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-3 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-4 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-5 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-8 - Application of risk management for IT-networks incorporating medical devices
- PD-IEC-80001-2-9 - Application of risk management for it-networks incorporating medical devices
- PD-IEC-80002-1 - Medical device software
- PD-IEC-80002-1-1 - Medical Device Software, Guidance on the Application of ISO-14971 To Medical Device So
- PD-IEC-80002-3 - Medical device software
- PD-ISO-14969 - Medical Devices, Quality Management Systems, Guidance on the Application of ISO-13485
- PD-ISO-16142 - Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
- PD-ISO-19218-2 - Medical devices. Hierarchical coding structure for adverse events
- PD-ISO-19244 - Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
- PD-ISO-24971 - Medical devices. Guidance on the application of ISO 14971
- PD-ISO-24971 EX COMM KIT - Medical devices. Guidance on the application of ISO 14971
- PD-ISO-24971 EXPERT COMM - Expert Commentary for PD ISO/TR 24971:2020. Medical devices. Guidance on the application of ISO 14971
- PD-ISO-24971-TC - Medical devices. Guidance on the application of ISO 14971
- PD-ISO-80001-2-6 - Application of risk management for IT-networks incorporating medical device
- PD-ISO-80001-2-7 - Application of risk management for IT-networks incorporating medical devices. Application guidance
- PD-ISO-80002-2 - Medical device software
- PD-ISO/IEC-GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
- PD-ISO/PAS-18761 - Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
IEC:
- IEC-1205 - Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics
- IEC-1289-1 - High frequency surgical equipment - Part 1: Operation
- IEC-1289-2 - High frequency surgical equipment - Part 2: Maintenance
- IEC-513 - Fundamental aspects of safety standards for medical electrical equipment
- IEC-60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC-60601-1-1 - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements F
- IEC-60601-1-10 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- IEC-60601-1-10-AM2 - Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- IEC-60601-1-11-AM1 - Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC-60601-1-12 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- IEC-60601-1-12-AM1 - Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- IEC-60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC-60601-1-2-1 - Amendment 1: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Co
- IEC-60601-1-2-AM1 - Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC-60601-1-4 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
- IEC-60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC-60601-1-6-AM2 - Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC-60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC-60601-1-8-1 - Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC-60601-1-8-AM2 - Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC-60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- IEC-60601-1-9-AM2 - Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- IEC-60601-1-AM2 - Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC-60601-1-SER - Medical electrical equipment - ALL PARTS
- IEC-60601-1-SERIES - Medical electrical equipment - ALL PARTS
- IEC-60601-2-22 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC-60601-2-22-AM1 - Amendment 1 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC-60601-2-30 - Part 2-30: Particular Requirements for the Safety, Includingessential Performance, of Aut
- IEC-60601-2-31 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- IEC-60601-2-31-1 - Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- IEC-60601-2-31-RL - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- IEC-60601-2-35 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
- IEC-60601-2-35-AM1 - Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
- IEC-60601-2-36 - Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
- IEC-60601-2-62 - Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
- IEC-60601-2-75 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
- IEC-60601-2-75-AM1 - Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
- IEC-60601-4-1 - Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
- IEC-60601-4-2 - Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- IEC-60601-4-3 - Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
- IEC-60601-4-3-RL - Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
- IEC-60601-4-4 - Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
- IEC-60601-4-5 - Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
- IEC-60601-4-6 - Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
- IEC-61289 - High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
- IEC-61289-RL - High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
- IEC-61847 - Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
- IEC-62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC-62366-1-AM1 - Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC-62366-2 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
- IEC-80001-1 - Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
- IEC-80001-2-1 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples
- IEC-80001-2-2 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
- IEC-80001-2-3 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
- IEC-80001-2-4 - Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
- IEC-80001-2-5 - Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
- IEC-80001-2-8 - Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
- IEC-80001-2-9 - Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
- IEC-80002-1 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC-80002-3 - Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
- IEC-80601-2-26 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC-80601-2-26-AM1 - Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC-80601-2-35 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- IEC-80601-2-35-AM1 - Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
- IEC-80601-2-60 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- IEC-80601-2-77 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
- IEC-80601-2-77-AM1 - Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
- IEC-80601-2-78 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
- IEC-81001-5-1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
ISO:
- IEC/DIS-80601-2-77 - Medical electrical equipment -- Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
- ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO-13485-HANDBOOK - Medical devices - A practical guide
- ISO-13488 - Quality systems - Medical devices - Particular requirements for the application of ISO 9002
- ISO-14969 - Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
- ISO-14971 - Medical devices - Application of risk management to medical devices
- ISO-14971-AM1 - Medical devices - Application of risk management to medical devicesAmendment 1: Rationale for requirements
- ISO-14971-RL - Medical devices - Application of risk management to medical devices
- ISO-14971 SPANISH - Medical devices - Application of risk management to medical devices [Standard in Spanish]
- ISO-15223 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
- ISO-15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- ISO-15223-1-AM 1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirementsAmendment 1
- ISO-15223-2 - Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
- ISO-15223-AM2 - Medical devices - Symbols to be used with medical device labels, labelling and information to be suppliedAmendment 2
- ISO-15223 PACKAGE - ISO 15223 - Symbols for Medical Devices Package
- ISO-15225 - Medical devices - Quality management - Medical device nomenclature data structure
- ISO-15225-1 - Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchangeAmendment 1
- ISO-15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- ISO-15378-AM1 - - Amendment 1: Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes
- ISO-16142 - Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
- ISO-16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
- ISO-16142-2 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
- ISO-19218 - Medical devices -- Coding structure for adverse event type and cause
- ISO-19218-1 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
- ISO-19218-1-AM1 - Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes- Amendment 1
- ISO-19218-2 - Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
- ISO-19244 - Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
- ISO-20069 - Guidance for assessment and evaluation of changes to drug delivery systems
- ISO-20225 - Global Medical Device Nomenclature for the Purpose of Regulatory Data Exchange
- ISO-20416 - Medical devices - Post-market surveillance for manufacturers
- ISO-20417 - Medical devices — Information to be supplied by the manufacturer
- ISO-24971 - Medical devices - Guidance on the application of ISO 14971
- ISO-24971-RL - Medical devices - Guidance on the application of ISO 14971
- ISO-32000-1 - Document management -- Portable document format -- Part 1: PDF 1.7
- ISO-80001-2-6 - Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
- ISO-80001-2-7 - Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
- ISO-80002-2 - Medical device software - Part 2: Validation of software for medical device quality systems
- ISO/DIS-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO/DIS-15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- ISO/IEC-GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
- ISO/PAS-18761 - Use and handling of medical devices covered by the scope of ISO/TC 84 - Risk assessment on mucocutaneous blood exposure
Other SDOs:
- AAMI/IEC-80001-1 - Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
- AAMI/IEC-80001-1-SET - Includes AAMI/IEC-80001-1 & AAMI/IEC-80001
- AAMI/IEC-80001-2-1 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples (ANSI/AAMI/IEC TIR80001-2-1:2012)
- AAMI/IEC-80001-2-2 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security
- AAMI/IEC-80001-2-3 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks (ANSI/AAMI/IEC TIR80001-2-3:2012)
- AAMI/IEC-80001-2-4 - Application of risk management for IT-networks incorporating medical devices, Part 2-4: Application guidance, General implementation guidance for healthcare delivery organizations
- AAMI/IEC-80001-2-5 - Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
- AAMI/IEC-80001-2-7 - Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
- AAMI/ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- AAMI/ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- AAMI/ISO-10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- AAMI/ISO-10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ANSI/AAMI/ISO 10993-12:2012)
- AAMI/ISO-10993-13 - Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices
- AAMI/ISO-10993-14 - Biological evaluation of medical devices, Part 14: Identification and quantification of degradation products from ceramics
- AAMI/ISO-10993-15 - Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys
- AAMI/ISO-10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
- AAMI/ISO-10993-17 - Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances
- AAMI/ISO-10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials
- AAMI/ISO-10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements
- AAMI/ISO-10993-3 - Biological evaluation of medical devices
- AAMI/ISO-10993-4 - Biological evaluation of medical devices, Part 4: Selection of tests for interactions with blood
- AAMI/ISO-10993-4/A1 - Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood - Amendment 1
- AAMI/ISO-10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- AAMI/ISO-10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- AAMI/ISO-10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ANSI/AAMI/ISO 10993-7:2008/(R)2012)
- AAMI/ISO-10993-8 - Part 8: Selection and Qualification of Reference Materials Forbiological Tests, Biologic
- AAMI/ISO-10993-9 - Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products
- AAMI/ISO-16142-2 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
- AFNOR-NF-EN-ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes - Dispositifs mdicaux - Systmes de management de la qualit - Exigences des fins rglementaires
- ANSI/AAMI/ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.
- ANSI/AAMI-ISO-14971 - Medical devices - Application of risk management to medical devices
- ANSI/AAMI/ISO-16142 - Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
- ANSI/AAMI/ISO-19218 - Medical Devices -- Coding Structure For Adverse Event Type And Cause
- CISPR-36-AM2 - Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- DIN-EN-13718-1 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German version EN 13718-1:2014
- DIN-EN-13718-2 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German version EN 13718-2:2015
- DIN-EN-60601-1-11 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- DIN-EN-980 - Symbols for use in the labelling of medical devices; German version EN 980:2008
- DIN-EN-ISO-10993-8 - Part 8: Selection and Qualification of Reference Materials Forbiological Tests, Biologic
- DIN-EN-ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
- DIN-EN-ISO-14155-1 - Part 1: General Requirements, Clinical Investigation of Medical Devices for Human Subj
- DIN-EN-ISO-14155-2 - Part 2: Clinical Investigation Plans, Clinical Investigation of Medical Devices for Hu
- DIN-EN-ISO-14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- DIN-EN-ISO-14971/A1 - Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AMD 1:2003)
- EN-1041 - Information supplied by the manufacturer of medical devices
- EN-13718-1 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
- EN-13718-2 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
- EN-15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- 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
- EN-60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- EN-60601-1-11 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- EN-60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- EN-60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- EN-60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- EN-60601-2-22 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- EN-60601-2-31 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
- EN-60601-2-36 - Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
- EN-60601-2-62 - Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
- EN-62304 - Medical device software - Software life-cycle processes
- EN-62353 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
- EN-62366 - Medical devices - Application of usability engineering to medical devices
- EN-80001-1 - Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
- EN-80601-2-35 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
- EN-80601-2-60 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- EN-980 - Symbols for use in the labelling of medical devices - Replaced by EN-ISO-15223-1
- EN-ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
- EN-ISO-14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- EN-ISO-15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- EN-ISO-15225 - Medical devices - Quality management - Medical device nomenclature data structure
- EN-ISO-15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- IEC-60601-1 SERIES - Medical electrical equipment - ALL PARTS
- JIS-Q-13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- JIS-Q-14971-1 - Medical devices -- Risk management -- Part 1: Application of risk analysis
- JIS-T-0601-1-2 - Medical electrical equipment -- Part 1-2: General requirements for safety -- Electromagnetic compatibility -- Requirements and tests
- JIS-T-14971 - Medical devices -- Application of risk management to medical devices
- SIS-CEN-17223 - Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
- SIS-CEN/CLC/TR-14060 - Medical device traceability enabled by unique device identification (UDI)
- SIS-CEN-ISO/TR-20416 - Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
- SIS-CEN-ISO/TR-24971 - Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
- SIS-CEN/TR-17223 - Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
- SIS-EN-60601-1 - Medical electrical equipment - Part 1: General requirements - Swedish Standard, English language edition
- SIS-EN-60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - Swedish standard, English language edition
- SIS-EN-60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- SIS-EN-60601-1-8 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - Swedish Standard, English Language Edition
- SIS-EN-62304 - Medical device software - Software life-cycle processes - Swedish standard, English language edition
- SIS-EN-80601-2-30 - Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers - Swedish Standard, English language edition
- SIS-EN-ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- SIS-EN-ISO-14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- SIS-EN-ISO-15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
- SIS-ISO/IEC-TR-62366-2 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
- SIS-ISO/TR-24971 - Medical devices - Guidance on the application of ISO 14971
- SS-845316 - Glass bottles - Medicine bottles with snap-on closures or with screw cap closures
- SS-EN-1041 - Information supplied by the manufacturer of medical devices
- SS-EN-13718-1 - Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
- SS-EN-13718-2 - Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
- SS-EN-1441 - Medical devices - Risk analysis
- SS-EN-15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- 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-455-1 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
- SS-EN-46001 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
- SS-EN-46003 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
- SS-EN-60601-1-1 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- SS-EN-60601-2-22 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- SS-EN-62353 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
- SS-EN-62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
- SS-EN-980 - Symbols for use in the labelling of medical devices
- SS-EN-ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
- SS-EN-ISO-11073-10406 - Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
- SS-EN-ISO-11073-10420 - Health informatics - Personal health device communication - Part 10420: Device specialization - Body composition analyzer (ISO 11073-10420:2012)
- SS-EN-ISO-11073-10421 - Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) (ISO 11073-10421:2012)
- SS-EN-ISO-11073-10472 - Health Informatics - Personal health device communication - Part 10472: Device specialization - Medication monitor (ISO 11073-10472:2012)
- SS-EN-ISO-11073-30400 - Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)
- SS-EN-ISO-11138-7 - Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
- SS-EN-ISO-11197 - Medical supply units (ISO 11197:2019)
- SS-EN-ISO-13485 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- SS-EN-ISO-13485-AM11 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- SS-EN-ISO-14155-1 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
- SS-EN-ISO-14155-2 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
- SS-EN-ISO-14161 - Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results (ISO 14161:2009)
- SS-EN-ISO-14971-AM11 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- SS-EN-ISO-15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
- SS-EN-ISO-15225 - Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
- SS-EN-ISO-15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
- SS-EN-ISO-17262 - Intelligent transport systems - Automatic vehicle and equipment identification - Numbering and data structures (ISO 17262:2012)
- SS-EN-ISO-1942-5 - Dental vocabulary - Part 5: Terms associated withtesting
- SS-EN-ISO-20342-1 - Assistive products for tissue integrity when lying down - Part 1: General requirements (ISO 20342-1:2022)
- SS-EN-ISO-20417 - Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
- SS-EN-ISO-21365 - Soil quality - Conceptual site models for potentially contaminated sites (ISO 21365:2019)
- SS-EN-ISO-4074 - Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
- SS-EN-ISO-80369-20 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
- SS-EN-ISO-80369-3 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
- SS-EN-ISO-80369-3-AM1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
- SS-EN-ISO-80369-7 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
- SS-EN-ISO-81060-3 - Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
- SS-EN-ISO/IEEE-11073-10420 - Health informatics - Device interoperability - Part 10420: Personal health device communication - Device specialization - Body composition analyzer (ISO/IEEE 11073-10420:2022)
- SS-ENV-13004 - Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
- SS-ISO-15223-2 - Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation (ISO 15223-2, IDT)
- SS-ISO-16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards (ISO 16142-1:2016, IDT)
- SS-ISO-16142-2 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards (ISO 16142-2:2017, IDT)
- SS-ISO-20417 - Medical devices - Information to be provided by the manufacturer (ISO 20417:2021, IDT)
- SS-ISO-3019-2 - Hydraulic fluid power - Dimensions and identification code for mounting flanges and shaft ends of displacement pumps and motors - Part 2: Metric series
- UNE-EN-60601-1-8 - Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- UNE-EN-60601-1-8/A1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- UNE-EN-ISO-15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- UNE-EN-ISO-15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)