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Standards [CURRENT]

DIN EN ISO 21393

Genomics informatics - Omics Markup Language (OML) (ISO 21393:2021); English version EN ISO 21393:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
Edition 2015-02

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

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

Standards [CURRENT]

DIN EN ISO 80601-2-67

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020); German version EN ISO 80601-2-67:2020
Edition 2021-06

Standards [CURRENT]

DIN EN ISO 11073-10418

Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor (ISO/IEEE 11073-10418:2014); English version EN ISO 11073-10418:2014
Edition 2014-06

Standards [CURRENT]

DIN EN 15224

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

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

Standards [CURRENT]

DIN EN ISO 12052

Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017); English version EN ISO 12052:2017
Edition 2017-12

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