Фильтр :
Стандарт и/или проект находящийся в компетенции ISO/TC 210 Секретариата | Этап | 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
|
30.60 |
|
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
|
40.60 | |
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
|
90.93 | |
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
|
90.93 | |
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
|
90.93 | |
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
|
40.00 | |
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
|
30.20 |
|
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
|
60.60 | |
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
|
60.00 |
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