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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 -- Performance evaluation -- Requirements and guidance
10.99 New project approved
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2026)
45.99 Dispatch of FV draft to CCMC
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137‑2:2026)
40.20 DIS ballot initiated: 12 weeks
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026)
40.60 Close of voting
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023)
40.60 Close of voting
Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAmd1:2025)
40.60 Close of voting
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO/DIS 23640:2026)
40.60 Close of voting
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
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
10.99 New project approved
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
40.60 Close of voting
