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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

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 20186-3

Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019); German version EN ISO 20186-3:2019
Edition 2020-04

Draft standard

DIN EN ISO 14607

Non-active surgical implants - Mammary implants - Specific requirements (ISO/DIS 14607:2023); German and English version prEN ISO 14607:2023
Edition 2023-09

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

Draft standard

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

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

Technical Report [CURRENT]

DIN/TR 10133

Toxicological assessment of additives for tobacco products - A guidance; Text in English
Edition 2021-09

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 rule [CURRENT]

VDI 2310 Blatt 12

Maximum ambient concentrations referring to human health - Maximum ambient concentrations for nitrogen dioxide
Edition 2004-12

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