• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information

  • Climate change Standards and specifications support climate targets

    More information

  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
 

Publications of ISO/TC 212/WG 3

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 2021-09 Draft standard 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 More  Order from DIN Media
DIN EN ISO 18113-2 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021 More  Order from DIN Media
DIN EN ISO 18113-3 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 More  Order from DIN Media
DIN EN ISO 18113-4 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021 More  Order from DIN Media
DIN EN ISO 18113-5 2021-09 Draft standard In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021 More  Order from DIN Media
DIN EN ISO 20916 2021-05 Draft standard In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 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
ISO 17593 2022-03 Standards Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy More  Order from DIN Media

TOP