Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements

Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings

Medical device maintenance management programme for healthcare delivery organizations (HDO)

Quality systems — Medical devices — Particular requirements for the application of ISO 9001

Medical devices — Quality management systems — Requirements for regulatory purposes

Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1

Medical devices — Quality management systems — Requirements for regulatory purposes

Quality systems — Medical devices — Particular requirements for the application of ISO 9002

Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488

Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003

Medical devices — Risk management — Part 1: Application of risk analysis

Medical devices — Application of risk management to medical devices

Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements

Medical devices — Application of risk management to medical devices

Medical devices — Application of risk management to medical devices

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

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

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1

Medical devices — Quality management — Medical device nomenclature data structure

Medical devices — Quality management — Medical device nomenclature data structure

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

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

Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications

Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes

Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1

Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes

Medical devices — Coding structure for adverse event type and cause

Global medical device nomenclature for the purpose of regulatory data exchange

Medical devices — Post-market surveillance for manufacturers

Medical devices — Post-market surveillance for manufacturers

Medical devices — Information to be supplied by the manufacturer

Medical devices — Information to be supplied by the manufacturer

Medical devices — Terminology — Terms used in the field of quality management and corresponding general aspects for products with a health purpose including medical devices

Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016

Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

Medical devices - Guidance on the application of ISO 14971 — Part 3: Combination products

Medical devices — Guidance on the application of ISO 14971

Medical devices — Guidance on the application of ISO 14971

Medical device software — Software life cycle processes

Medical device software — Software life cycle processes — Amendment 1

Medical devices — Part 1: Application of usability engineering to medical devices

Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1

Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Medical devices — Part 2: Guidance on the application of usability engineering to medical devices

Medical devices — Application of usability engineering to medical devices

Medical devices — Application of usability engineering to medical devices — Amendment 1

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

Medical device software — Part 2: Validation of software for medical device quality systems

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications

Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications

Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1

Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications

Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 1

Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 2

Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications

Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications

Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications

Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods

Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods