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Standard and/or project under the direct responsibility of ISO/TC 210 Secretariat | Stage | ICS |
---|---|---|
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
95.99 | |
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
95.99 | |
Medical device maintenance management for healthcare delivery organizations |
30.20 |
|
Quality systems — Medical devices — Particular requirements for the application of ISO 9001 |
95.99 | |
Medical devices — Quality management systems — Requirements for regulatory purposes |
95.99 | |
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 |
95.99 | |
Medical devices — Quality management systems — Requirements for regulatory purposes |
90.93 | |
Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
95.99 | |
Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488 |
95.99 | |
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 |
95.99 | |
Medical devices — Risk management — Part 1: Application of risk analysis |
95.99 | |
Medical devices — Application of risk management to medical devices |
95.99 | |
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements |
95.99 | |
Medical devices — Application of risk management to medical devices |
95.99 | |
Medical devices — Application of risk management to medical devices |
60.60 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1 |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
95.99 | |
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements |
60.60 | |
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific |
40.00 | |
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
90.92 | |
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
20.00 |
|
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1 |
95.99 | |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2 |
95.99 | |
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange |
95.99 | |
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1 |
95.99 | |
Medical devices — Quality management — Medical device nomenclature data structure |
95.99 | |
Medical devices — Quality management — Medical device nomenclature data structure |
95.99 | |
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 |
95.99 | |
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 |
95.99 | |
Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
95.99 | |
Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
95.99 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods |
90.60 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications |
90.92 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications |
20.00 |
|
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications |
90.20 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion |
90.60 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications |
90.60 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications — Amendment 1 |
20.00 | |
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes |
95.99 | |
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1 |
95.99 | |
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes |
95.99 | |
Medical devices — Coding structure for adverse event type and cause |
95.99 | |
Global medical device nomenclature for the purpose of regulatory data exchange |
95.99 | |
Medical devices — Post-market surveillance for manufacturers |
60.60 | |
Medical devices — Information to be supplied by the manufacturer |
90.92 | |
Medical devices — Information to be supplied by the manufacturer |
30.99 | |
Medical devices — Terminology — Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices |
20.00 |
|
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence |
30.00 |
|
Medical devices — Guidance on the application of ISO 14971 |
95.99 | |
Medical devices — Guidance on the application of ISO 14971 |
60.60 | |
Medical device software — Software life cycle processes |
90.93 | |
Medical device software — Software life cycle processes — Amendment 1 |
60.60 | |
Medical devices — Part 1: Application of usability engineering to medical devices |
90.93 | |
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1 |
60.60 | |
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1 |
60.60 | |
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices |
90.92 | |
Medical devices — Application of usability engineering to medical devices |
95.99 | |
Medical devices — Application of usability engineering to medical devices — Amendment 1 |
95.99 | |
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software |
60.60 | |
Medical device software — Part 2: Validation of software for medical device quality systems |
60.60 | |
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
60.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
95.99 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
90.92 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
50.00 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications |
50.20 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
90.93 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1 |
60.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications |
90.92 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 1 |
60.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 2 |
60.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications |
10.99 |
|
Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
90.92 | |
Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications |
40.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
95.99 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
60.60 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
90.92 | |
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
50.00 |
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