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DIN EN 455-3
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2023
Edition
2024-02
DIN EN ISO 23908
Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023); German and English version prEN ISO 23908:2023
Edition
2023-11
DIN EN ISO 80369-1
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2023); German and English version prEN ISO 80369-1:2023
Edition
2023-07
DIN EN ISO 15883-7
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024); German and English version prEN ISO 15883-7:2024
Edition
2024-03
DIN EN 14683
Medical face masks - Requirements and test methods; German and English version prEN 14683:2023
Edition
2023-10
DIN EN ISO 25424
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018 + Amd 1:2022); German version EN ISO 25424:2019 + A1:2022
Edition
2022-07
DIN EN ISO 20916
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024
Edition
2024-07
DIN EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023
Edition
2024-02
DIN EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
Edition
2023-04
DIN EN ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
Edition
2023-11