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Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
60.60 Standard published
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 TR 80001-2-2
60.60 Standard published
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971
60.60 Standard published
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - 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 devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
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 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
60.60 Standard published
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
60.60 Standard published
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
60.60 Standard published
Information supplied by the manufacturer of medical devices
60.60 Standard published
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
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