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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60   Standard published

CEN/CLC/JTC 3

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

CEN/CLC/JTC 3

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

CEN/CLC/JTC 3

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

CEN/CLC/JTC 3

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

CEN/CLC/JTC 3
CEN/CENELEC

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

90.93   Standard confirmed

CEN/CLC/JTC 3
CEN/CENELEC

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

90.93   Standard confirmed

CEN/CLC/JTC 3

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60   Standard published

CEN/CLC/JTC 3

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60   Standard published

CEN/CLC/JTC 3



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