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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

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 [CURRENT]

DIN EN ISO 21976

Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018); German version EN ISO 21976:2020
Edition 2020-12

Standards [CURRENT]

DIN ISO 21882

Sterile packaged ready for filling glass vials (ISO 21882:2019)
Edition 2020-12

Standards [CURRENT]

DIN ISO 21881

Sterile packaged ready for filling glass cartridges (ISO 21881:2019)
Edition 2020-12

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 ISO 11040-6

Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019)
Edition 2021-05

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

Standards [CURRENT]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
Edition 2021-05

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