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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

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

DIN CEN ISO/TS 16775

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021
Edition 2022-04

Technical rule [CURRENT]

DIN-Fachbericht CEN/TR 15753

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people; German version CEN/TR 15753:2008
Edition 2008-08

Technical rule [CURRENT]

VDI 5700 Blatt 3

Hazards in medical areas - Risks of detectable surface changes on invasive medical devices - Measures for risk control
Edition 2019-10

Technical rule [CURRENT]

VDI-MT 5700 Blatt 2

Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings
Edition 2023-03

Technical rule [CURRENT]

VDI 5705 Blatt 1

Digital process chains in industrial medical technology - Production of custom-made devices
Edition 2022-11

Technical rule [CURRENT]

VDI 2017

Medical Grade Plastics (MGP)
Edition 2019-07

Technical rule [CURRENT]

VDI 5703 Blatt 1

Systematical development for a model-based testing of medical devices - Fundamentals
Edition 2021-12

Technical rule [CURRENT]

VDI-EE 6306

3rd-Party GMP Audits - Supplier audits in the pharmaceutical industry
Edition 2024-03

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