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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 (ISO 15378:2017/Amd 1:2024)
60.60 Standard published
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
60.60 Standard published
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
60.60 Standard published
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
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
60.60 Standard published
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
60.60 Standard published
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
60.60 Standard published
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
60.60 Standard published
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
60.60 Standard published
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
60.60 Standard published
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
60.60 Standard published
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
60.60 Standard published
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
60.60 Standard published