Document Center List of Standards on Medical Equipment
ICS Code 11.040
Return to ICS Index.Up to Level 1:
Down to Level 3:
- 11.040.01 (Medical equipment in general)
- 11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
- 11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)
- 11.040.25 (Syringes, needles and catheters)
- 11.040.30 (Surgical instruments and materials Including surgical dressings, sutures, etc.)
- 11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)
- 11.040.50 (Radiographic equipment Including radiographic diagnostic and therapy equipment Dental, medical and industrial radiographic films, see 37.040.25)
- 11.040.55 (Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials)
- 11.040.60 (Therapy equipment)
- 11.040.70 (Ophthalmic equipment Including ophthalmic implants, glasses, contact lenses and their cleaning products)
- 11.040.99 (Other medical equipment)
The following documents are a part of this series:
BSI:
- BS-5736-5 - Evaluation of medical devices for biological hazards. Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices (Withdrawn)
- BS-5736-7 - Evaluation of medical devices for biological hazards. Method of test for skin irritation of extracts from medical devices (Withdrawn)
- BS-5736-9 - Evaluation of medical devices for biological hazards. Method of test for eye irritation (Withdrawn)
- PAS-377 - Consumables used in the collection, preservation and processing of material for forensic analysis. Product, manufacturing and forensic kit assembly. Specification
- PD-IEC-60601-4-3 - Medical electrical equipment
IEC:
- IEC-1258 - Guidelines for the development and use of medical electrical equipment educational materials
- IEC-60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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-AM1 - Amendment 1 - 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 - 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-60601-1-11-RL - 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-60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC-60601-1/60601-1- - IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package
- IEC-60601-1-6-AM1 - Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- 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-AM1 - Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- IEC-60601-1-AM1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC-60601-1-SER - Medical electrical equipment - ALL PARTS
- 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-60601-2-76 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
- IEC-60601-2-76-AM1 - Amendment 1 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
- 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-60930 - Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
- IEC-61258 - Guidelines for the development and use of medical electrical equipment educational materials
- IEC-61852 - Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects
- IEC-61859 - Guidelines for radiotherapy treatment rooms design
- IEC-62296 - Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
- IEC-62304 - Medical device software - Software life cycle processes
- IEC-62304-AM1 - Amendment 1 - Medical device software - Software life cycle processes
- IEC-62348 - Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
- IEC-62353 - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
- IEC-62354 - General testing procedures for medical electrical equipment
- IEC-62366 - Medical devices - Application of usability engineering to medical devices
- IEC-62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC-62366-AM1 - Amendment 1 - Medical devices - Application of usability engineering to medical devices
- IEC-80601-2-30 - Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC-80601-2-30-AM1 - Amendment 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers
- IEC-80601-2-30-RL - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Other SDOs:
- EN-60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- EN-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
- 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-60601-1-12 - 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
- EN-60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- EN-60601-1-A11 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- EN-62304 - Medical device software - Software life-cycle processes
- EN-62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices
- EN-80601-2-30 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- EN-IEC-80601-2-30 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2018)
- SIS-EN-60601-1-6 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- SIS-EN-62366 - Medical devices - Application of usability engineering to medical devices - Swedish Standard, English language edition
- SIS-EN-ISO-14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- SS-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
- SS-EN-ISO-13488 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)
- SS-EN-ISO-8321-2 - Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 2: Single-vision hydrogen lenses (ISO 8321-2:2000)
- SS-EN-ISO-8980-4 - Ophthalmic optics - Uncut finished spectacle lenses - Part 4: Specifications and test methods for anti-reflective coatings (ISO 8980-4:2006)
- SS-EN-ISO-9360-1 - Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
- SS-EN-ISO-9913-2 - Optics and optical instruments - Contact lenses - Part 2: Determination of oxygen permeability and transmissibility by the coulometric method (ISO 9913-2:2000)
- SS-EN-ISO-9997 - Dentistry - Cartridge syringes (ISO 9997:2020)
- 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)
- UNE-EN-ISO-16671 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery