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Standards [CURRENT]

DIN EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023
Edition 2024-04

Draft standard

DIN EN ISO 15193

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023
Edition 2024-02

Draft standard

DIN EN ISO 15883-2

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023); German and English version prEN ISO 15883-2:2023
Edition 2023-05

Draft standard

DIN EN ISO 1135-4

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023); German and English version prEN ISO 1135-4:2023
Edition 2023-11

Draft standard

DIN EN ISO 1135-5

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023); German and English version prEN ISO 1135-5:2023
Edition 2023-11

Draft standard

DIN EN 13795-2

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits; German and English version prEN 13795-2:2023
Edition 2023-10

Draft standard

DIN EN ISO 15194

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023
Edition 2024-02

Draft standard

DIN EN 13795-1

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns; German and English version prEN 13795-1:2023
Edition 2023-10

Draft standard

DIN EN ISO 18562-1

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022); German and English version prEN ISO 18562-1:2022
Edition 2022-12

Draft standard

DIN EN 17948

Maintenance function and management; German and English version prEN 17948:2023
Edition 2023-04

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