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Standards [CURRENT]

DIN EN ISO 10993-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
Edition 2018-02

Standards [CURRENT]

DIN 58989

Haemostaseology - HPLC-MS methods for the quantification of direct oral anticoagulants (DOAC) - Rivaroxaban; Text in German and English
Edition 2018-10

Standards [CURRENT]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
Edition 2022-09

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 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 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

Standards [CURRENT]

DIN EN 15004-1

Fixed firefighting systems - Gas extinguishing systems - Part 1: Design, installation and maintenance (ISO 14520-1:2015, modified); German version EN 15004-1:2019
Edition 2019-06

Standards [CURRENT]

DIN EN ISO 20776-1

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12); German version EN ISO 20776-1:2020
Edition 2020-12

Standards [CURRENT]

DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
Edition 2015-02

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