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Standards [CURRENT]

DIN 12980

Laboratory installations - Safety cabinets and glove boxes for cytotoxic substances and other CMR drugs
Edition 2017-05

Standards [CURRENT]

DIN EN ISO 11238

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018); German version EN ISO 11238:2018
Edition 2018-11

Standards [CURRENT]

DIN EN ISO 11239

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2023); German version EN ISO 11239:2023
Edition 2023-10

Standards [CURRENT]

DIN EN ISO 11240

Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of units of measurement (ISO 11240:2012); German version EN ISO 11240:2012
Edition 2013-03

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 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 [New]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

Standards [CURRENT]

DIN EN ISO 15378

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
Edition 2018-04

Draft standard

DIN EN ISO 15378/A1

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024); German and English version EN ISO 15378:2017/prA1:2024
Edition 2024-05

Technical Specification

DIN CEN ISO/TS 20440

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023); German version CEN ISO/TS 20440:2023
Edition 2023-09

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