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Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025)
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
40.20 DIS ballot initiated: 12 weeks
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
40.20 DIS ballot initiated: 12 weeks
Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing
40.20 DIS ballot initiated: 12 weeks
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
40.20 DIS ballot initiated: 12 weeks
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
40.20 DIS ballot initiated: 12 weeks
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)
40.20 DIS ballot initiated: 12 weeks
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024)
40.20 DIS ballot initiated: 12 weeks
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
40.20 DIS ballot initiated: 12 weeks
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
40.20 DIS ballot initiated: 12 weeks
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
40.20 DIS ballot initiated: 12 weeks
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
40.20 DIS ballot initiated: 12 weeks
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
40.20 DIS ballot initiated: 12 weeks
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
40.20 DIS ballot initiated: 12 weeks
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