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Standards [CURRENT]

DIN EN ISO 9999

Assistive products - Classification and terminology (ISO 9999:2022); German version EN ISO 9999:2022
Edition 2022-10

Standards [CURRENT]

DIN EN ISO 5840-1

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021); German version EN ISO 5840-1:2021
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 5840-2

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 20789

Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018); German version EN ISO 20789:2019
Edition 2020-02

Technical rule [CURRENT]

DIN SPEC 92001-3

Artificial Intelligence - Life Cycle Processes and Quality Requirements - Part 3: Explainability; Text in English
Edition 2023-08

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

Draft standard [New]

DIN EN ISO/IEEE 11073-10701

Health informatics - Device interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System (ISO/IEEE FDIS 11073-10701:2024); English version prEN ISO IEEE 11073-10701:2024
Edition 2024-07

Standards [CURRENT]

DIN EN 15224

Quality management systems - EN ISO 9001:2015 for healthcare; German version EN 15224:2016
Edition 2017-05

Standards [CURRENT]

DIN EN ISO 80601-2-85

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021); German version EN ISO 80601-2-85:2021
Edition 2022-01

Standards [CURRENT]

DIN EN ISO 5840-3

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021
Edition 2021-05

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