Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Specification and demonstration of system reliability of single-use drug delivery systems

Medical supply units

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

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

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) — Amendment 1: Climate action changes

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

Use and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure

Clinical evaluation of medical devices

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

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

Guidance for assessment and evaluation of changes to drug delivery systems

Global medical device nomenclature for the purpose of regulatory data exchange

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

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 — Application of usability engineering to medical devices

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

Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities

Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls

Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations

Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems

Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

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)

Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1

Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1