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Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1
10.99 New project approved
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
10.99 New project approved
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
10.99 New project approved
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
10.99 New project approved
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
10.99 New project approved
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
10.99 New project approved
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
45.99 Dispatch of FV draft to CCMC
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
45.99 Dispatch of FV draft to CCMC
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
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
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
Medical devices - Information to be supplied by the manufacturer
30.99 CD approved for registration as DIS
Medical devices - Information to be supplied by the manufacturer
30.99 CD approved for registration as DIS
