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Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Medical device traceability enabled by unique device identification (UDI)
60.60 Standard published
Nomenclature - Collective terms and codes for groups of medical devices
60.60 Standard published
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
60.60 Standard published
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
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
60.60 Standard published
Medical device software — Part 2: Validation of software for medical device quality systems
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 vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
40.60 Close of voting
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
40.60 Close of voting
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
40.60 Close of voting
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
40.60 Close of voting
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