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
20.60
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
40.00
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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