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Standards [CURRENT]

DIN EN ISO 8536-2

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023); German version EN ISO 8536-2:2023
Edition 2023-05

Standards [CURRENT]

DIN EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007
Edition 2008-03

Standards [CURRENT]

DIN EN ISO 11616

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2017); German version EN ISO 11616:2017
Edition 2018-04

Standards [CURRENT]

DIN EN ISO 5659-2

Plastics - Smoke generation - Part 2: Determination of optical density by a single-chamber test (ISO 5659-2:2017); German version EN ISO 5659-2:2017
Edition 2017-11

Standards [CURRENT]

DIN EN ISO 13943

Fire safety - Vocabulary (ISO 13943:2017); German and English version EN ISO 13943:2017
Edition 2018-01

Standards [CURRENT]

DIN EN ISO 17665-1

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006
Edition 2006-11

Standards [CURRENT]

DIN EN ISO 15883-7

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016); German version EN ISO 15883-7:2016
Edition 2016-10

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

Standards [CURRENT]

DIN EN ISO 11615

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition 2022-12

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015); German version EN ISO 12417-1:2015
Edition 2016-02

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