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Standards [CURRENT]

DIN EN ISO 11608-1

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022); German version EN ISO 11608-1:2022
Edition 2022-09

Draft standard

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO/DIS 12417-1:2021); German and English version prEN ISO 12417-1:2021
Edition 2021-11

Standards [available pre-publication]

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

Technical Specification

DIN CEN ISO/TS 16791

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020); German version CEN ISO/TS 16791:2020
Edition 2021-02

Technical Specification [CURRENT]

DIN CEN ISO/TS 20451 ; DIN SPEC 13264:2018-11

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017); English version CEN ISO/TS 20451:2018
Edition 2018-11

Technical Specification [CURRENT]

DIN CEN ISO/TS 17251 ; DIN SPEC 13237:2016-10

Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016); English version CEN ISO/TS 17251:2016
Edition 2016-10

Technical rule [CURRENT]

ONR 2915753

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people (CEN/TR 15753)
Edition 2008-12-01

Technical Specification [CURRENT]

DIN CEN ISO/TS 14441 ; DIN SPEC 58996:2014-04

Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment (ISO/TS 14441:2013); German version CEN ISO/TS 14441:2013
Edition 2014-04

Technical Specification [New]

DIN CEN ISO/TS 5499

Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024); English version CEN ISO/TS 5499:2024
Edition 2024-05

Technical Specification

DIN CEN ISO/TS 22756

Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020); English version CEN ISO/TS 22756:2020
Edition 2021-02

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