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Projects of ISO/TC 212/WG 3

DIN EN ISO 23640 rev 2024-03-15 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More  Comment 
ISO/AWI 23640 2024-03-01 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More  Comment 
ISO/AWI 24884 2024-02-20 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices (Minimum required information and means of delivery) More  Comment 
ISO/AWI TS 24883 2024-02-20 Lateral flow immunoassay for rapid diagnostic testing - General guideline for test performance More  Comment 
ISO/CD TS 16766 2022-09-06 Manufacturers'considerations for in vitro diagnostic medical devices in a public health crisis More  Comment 
DIN EN ISO 20916 2019-12-20 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  Comment 
DIN EN ISO 18113-1 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2022); German version FprEN ISO 18113-1:2022 More  Comment 
DIN EN ISO 18113-2 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022); German version FprEN ISO 18113-2:2022 More  Comment 
DIN EN ISO 18113-3 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022); German version FprEN ISO 18113-3:2022 More  Comment 
DIN EN ISO 18113-4 2019-12-06 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022); German version FprEN ISO 18113-4:2022 More  Comment 

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