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.
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 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