Projects

Use the form below to find particular standards or projects. Enter your criteria for searching (single or in combination) in the fields below and press the button “Search”. You can also search using the Advance Search facility.

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

Sterilization - Steam sterilizers - Large sterilizers

60.60 Standard published

CEN/TC 102

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

60.60 Standard published

CEN/CLC/JTC 3

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

60.60 Standard published

CEN/CLC/JTC 3

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

CLC/TC 62

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

CLC/TC 62

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

60.60 Standard published

CEN/TC 206

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

60.60 Standard published

CEN/TC 204

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

CEN/TC 204

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

CEN/TC 102