ICS 11.100
Laboratory medicine
Standards in This Category
EVS-EN ISO 22367:2026
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2026)
EVS-EN ISO 14155:2026
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)
EVS-EN ISO 18704:2026
Molecular in vitro diagnostic examinations - Requirements and recommendations for pre-examination processes for urine and other body fluids - Isolated cell-free DNA (ISO 18704:2026)
EVS-EN ISO 10993-1:2026
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
EVS-EN ISO 5649:2024
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
EVS-EN ISO 18113-3:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
EVS-EN ISO 18113-5:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
EVS-EN ISO 18113-4:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
EVS-EN ISO 18113-1:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
EVS-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)
GS ISO 10993-5:2020
Part 5: Tests for in vitro cytotoxicity
GS ISO 10993-1:2020
Part 1: Evaluation and testing within a risk management process
EVS-EN ISO 20916:2024
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
EVS-EN ISO 10993-17:2023
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EVS-EN ISO 10993-15:2023
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
EVS-EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
EVS-EN ISO 10993-2:2022
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EVS-EN ISO 20776-2:2022
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 susceptibilit...
EVS-EN ISO 4307:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
EVS-EN ISO 16256:2021