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Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1

10.99 New project approved

CEN/TC 204

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

10.99 New project approved

CEN/TC 140

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

10.99 New project approved

CEN/TC 140

Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

10.99 New project approved

CEN/TC 204

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

30.99 CD approved for registration as DIS

CEN/TC 204

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

10.99 New project approved

CEN/TC 140

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024)

45.99 Dispatch of FV draft to CCMC

CEN/TC 204

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

45.99 Dispatch of FV draft to CCMC

CEN/TC 140

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

45.99 Dispatch of FV draft to CCMC

CEN/TC 140

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101 Particular requirements for in vitro diagnostic (IVD) medical equipment

30.99 CD approved for registration as DIS

CLC/TC 66X

Medical device software - Software life cycle processes

10.99 New project approved

CLC/TC 62

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

20.60 Close of comment period

CLC/TC 65X

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/DAM 1:2024)

60.55 Ratification completed (DOR)

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/DAM 1:2024)

60.55 Ratification completed (DOR)

CEN/CLC/JTC 3

Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)

40.20 DIS ballot initiated: 12 weeks

CEN/CLC/JTC 3

Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)

40.20 DIS ballot initiated: 12 weeks

CEN/CLC/JTC 3