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Hydrogen Technologies Standards form the basic framework for market ramp-up
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Publications of ISO/TC 212/WG 3

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DIN EN ISO 15197	2015-12	Standards	In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 More	Order from DIN Media
DIN EN ISO 18113-1	2024-10	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024 More	Order from DIN Media
DIN EN ISO 18113-2	2024-10	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024 More	Order from DIN Media
DIN EN ISO 18113-3	2024-10	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022); German version EN ISO 18113-3:2024 More	Order from DIN Media
DIN EN ISO 18113-4	2024-10	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022); German version EN ISO 18113-4:2024 More	Order from DIN Media
DIN EN ISO 18113-5	2024-10	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022); German version EN ISO 18113-5:2024 More	Order from DIN Media
DIN EN ISO 20916	2024-07	Standards	In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024 More	Order from DIN Media
ISO/TS 17518	2015-04	Pre-standard	Medical laboratories - Reagents for staining biological material - Guidance for users More	Order from DIN Media
ISO 15197	2013-05	Standards	In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus More	Order from DIN Media
ISO 15198	2004-07	Standards	Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer More	Order from DIN Media

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