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Standards [CURRENT]

DIN EN ISO 17511

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
Edition 2021-11

Standards [CURRENT]

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
Edition 2013-01

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 16602-70-55

Space product assurance - Microbiological examination of flight hardware and cleanrooms; English version EN 16602-70-55:2015
Edition 2015-12

Draft standard

DIN EN ISO 22174

Microbiology of the food chain - Polymerase chain reaction (PCR) for the detection and quantification of microorganisms - General requirements and definitions (ISO/DIS 22174:2022); German and English version prEN ISO 22174:2022
Edition 2022-11

Standards [CURRENT]

DIN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Edition 2017-12

Draft standard

DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024); German and English version prEN ISO 7405:2024
Edition 2024-04

Draft standard

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021
Edition 2021-09

Draft standard

DIN EN ISO 7218

Microbiology of the food chain - General requirements and guidance for microbiological examinations (ISO/DIS 7218:2022); German and English version prEN ISO 7218:2022
Edition 2022-07

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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