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Publications of CEN/TC 140

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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 18153	2003-11	Standards	In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More	Order from DIN Media
DIN EN ISO 19001	2013-07	Standards	In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 More	Order from DIN Media
DIN EN ISO 20776-1	2020-12	Standards	Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12); German version EN ISO 20776-1:2020 More	Order from DIN Media
DIN EN ISO 20776-2	2022-04	Standards	Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021); German version EN ISO 20776-2:2022 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

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