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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 15747

Plastic containers for intravenous injections (ISO 15747:2018); German version EN ISO 15747:2019
Edition 2019-07

Draft standard

DIN EN ISO 15747

Plastic containers for intravenous injections (ISO/DIS 15747:2025); German and English version prEN ISO 15747:2025
Edition 2025-06

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

Standards [CURRENT]

DIN EN ISO 14607

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018
Edition 2018-10

Standards [CURRENT]

DIN ISO 11040-8

Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016)
Edition 2020-11

Draft standard

DIN EN ISO 16791

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/DIS 16791:2025); German and English version prEN ISO 16791:2025
Edition 2025-05

Standards [CURRENT]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
Edition 2023-11

Standards [CURRENT]

DIN EN ISO 15883-5

Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021); German version EN ISO 15883-5:2021
Edition 2021-11

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