Standards catalogue

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

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

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 -- Application of risk management to medical devices

Rationale for requirements

Medical devices -- Application of risk management to medical devices

Medical devices -- Application of risk management to medical devices

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

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 -- 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 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 2: Symbol development, selection and validation

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

Medical devices -- Quality management -- Medical device nomenclature data structure

Medical devices -- Quality management -- Medical device nomenclature data structure

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 -- 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 -- 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

Connectors for reservoir delivery systems for healthcare applications -- Part 6: Neural applications

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 -- Coding structure for adverse event type and cause

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

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

Global medical device nomenclature for the purpose of regulatory data exchange

Medical devices -- Post-market surveillance for manufacturers

Medical Devices -- Requirements for general information to be provided by the manufacturer

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 devices -- Application of usability engineering to medical devices

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

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

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 3: Connectors for enteral applications

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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 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 7: Connectors for intravascular or hypodermic applications

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