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Project

prEN 868-7

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

Security of medical electrical equipment containing high-activity sealed radioactive sources (IEC/CDV 63322:2024); German and English version prEN IEC 63322:2024

Project

prEN 14476

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023)

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023)

Acceptance testing of nuclear medical measuring systems - Part 101: Radiation counting systems for measurements in vivo and in vitro

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)

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