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Draft standard

DIN EN ISO 18562-3

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO/DIS 18562-3:2022); German and English version prEN ISO 18562-3:2022
Edition 2022-12

Draft standard

DIN EN ISO 18562-2

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO/DIS 18562-2:2022); German and English version prEN ISO 18562-2:2022
Edition 2022-12

Draft standard

DIN EN ISO 15883-3

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/DIS 15883-3:2023); German and English version prEN ISO 15883-3:2023
Edition 2023-05

Draft standard

DIN EN ISO 12870

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022); German and English version prEN ISO 12870:2022
Edition 2022-03

Draft standard

DIN EN ISO 22248

Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020); German and English version prEN ISO 22248:2024
Edition 2024-03

Standards [CURRENT]

DIN EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
Edition 2023-07

Draft standard

DIN EN ISO 14630

Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022
Edition 2022-10

Draft standard

DIN EN ISO 18562-4

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO/DIS 18562-4:2022); German and English version prEN ISO 18562-4:2022
Edition 2022-12

Draft standard

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
Edition 2023-05

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