Projects

Information supplied by the manufacturer of medical devices

90.92   Standard to be revised

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

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

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

90.92   Standard to be revised

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

90.92   Standard to be revised

Medical device traceability enabled by unique device identification (UDI)

90.60   Close of review

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

Nomenclature - Collective terms and codes for groups of medical devices

90.60   Close of review

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60   Standard published

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 (ISO 15223 1:2021/Amd 1:2025)

60.60   Standard published

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

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) (ISO 15378:2017)

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 (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

90.93   Standard confirmed

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

60.60   Standard published