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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 11737-1

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
Edition 2021-10

Draft standard [New]

DIN EN 14476

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1); German and English version prEN 14476:2024
Edition 2024-07

Standards [CURRENT]

DIN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Edition 2017-12

Draft standard

DIN ISO 11040-4

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO/DIS 11040-4:2023); Text in German and English
Edition 2023-05

Technical Report [CURRENT]

DIN ISO/TR 18811

Cosmetics - Guidelines on the stability testing of cosmetic products (ISO/TR 18811:2018)
Edition 2022-01

Technical rule [CURRENT]

DIN SPEC 91323

Temperature conditioned transport equipment used for the distribution of pharmaceutical products (for human beings or veterinary use) - Guidelines for qualification
Edition 2016-03

Technical Specification [CURRENT]

DIN CEN ISO/TS 19844 ; DIN SPEC 13261:2017-12

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Edition 2017-12

Technical rule [CURRENT]

VDI 2017

Medical Grade Plastics (MGP)
Edition 2019-07

 
Edition 2016-10

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