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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
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
10.99 New project approved
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
50.60 Close of voting. Proof returned by secretariat
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices
45.99 Dispatch of FV draft to CCMC
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
60.55 Ratification completed (DOR)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
60.55 Ratification completed (DOR)
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
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 - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
40.60 Close of voting
In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)
40.60 Close of voting
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
10.99 New project approved
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
10.00 Proposal for new project registered