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Draft standard

DIN EN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
Edition 2018-11

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 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 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO/DIS 13408-1:2021); German and English version prEN ISO 13408-1:2021
Edition 2022-06

Standards [New]

DIN EN ISO 11139

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024
Edition 2024-06

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

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

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 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 Specification [CURRENT]

DIN CEN ISO/TS 20443 ; DIN SPEC 13263:2018-11

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018
Edition 2018-11

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