CEN/TC 140
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
5099 | EN 376:2002 | Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing | Atcelts |
5069 | EN 928:1995 | In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices | Atcelts |
78630 | prEN ISO 22367 | Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22637:2025) | Aptauja slēgta |
77454 | prEN ISO 18704 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024) | Aptauja slēgta |
77643 | EN ISO 5649:2024 | Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024) | Standarts spēkā |
70930 | EN ISO 18113-2:2024 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022) | Standarts spēkā |
61690 | LVS EN ISO 20166-2:2019 | Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018) | Standarts spēkā |
71064 | EN ISO 20916:2024 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019) | Standarts spēkā |
61695 | LVS EN ISO 20184-2:2019 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018) | Standarts spēkā |
64279 | LVS EN ISO 22367:2020 | Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020) | Standarts spēkā |
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