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Standards [CURRENT]

DIN EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
Edition 2021-10

Standards [CURRENT]

DIN EN ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
Edition 2023-04

Standards [CURRENT]

DIN EN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Edition 2009-10

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

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

Standards [CURRENT]

DIN ISO 3384-1

Rubber, vulcanized or thermoplastic - Determination of stress relaxation in compression - Part 1: Testing at constant temperature (ISO 3384-1:2019)
Edition 2022-04

Draft standard

DIN EN ISO 18562-4

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO/DIS 18562-4:2022); German and English version prEN ISO 18562-4:2022
Edition 2022-12

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

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