ICS 11.100
Laboratory medicine
Standards in This Category
EVS-EN ISO 10993-9:2021
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
EVS-EN ISO 6717:2021
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
EVS-EN ISO 20166-4:2021
Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)
EVS-EN ISO 23162:2021
Basic semen examination - Specification and test methods (ISO 23162:2021)
EVS-EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
EVS-EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
EVS-EN ISO 23118:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)
EVS-EN ISO 20184-3:2021
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
EVS-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EVS-EN ISO 22442-1:2020
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
EVS-ISO 15190:2020
Medical laboratories - Requirements for safety (ISO 15190:2020, identical)
EVS-EN ISO 22442-2:2020
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
EVS-EN ISO 20776-1:2020
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 aer...
LVS EN ISO 4307:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
This document establishes technical guidelines concerning the pre-treatment procedures for saliva samples used in in vitro molecular diagnostic testing, specifically focusing on the isolation of
LVS EN ISO 5649:2025
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
This document establishes a comprehensive framework for the conceptual design and technical specifications related to the development, implementation, and utilization of tests created within medical
LVS CEN ISO/TS 5798:2023
In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)
This document establishes comprehensive requirements and recommendations for in vitro diagnostic systems utilizing nucleic acid amplification techniques to detect the Severe Acute Respiratory
LVS EN ISO 6717:2021
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
This specification establishes essential requirements for single-use containers designed to collect biological samples from humans, excluding blood specimens. Intended for the in vitro diagnostic
LVS EN ISO 7405:2026
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)
This technical specification addresses the biological evaluation of dental materials and devices, establishing a framework to assess their safety when interacting with human oral tissues. It outlines
LVS CEN ISO/TS 7552-2:2025
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 2: Isolated DNA (ISO/TS 7552-2:2024)
This document establishes comprehensive guidelines for the pre-processing of venous blood specimens intended for detecting circulating tumor cells within the framework of in vitro diagnostic testing.
LVS CEN ISO/TS 7552-1:2025
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 1: Isolated RNA (ISO/TS 7552-1:2024)
This technical specification outlines the standardized procedures for processing whole blood samples to isolate circulating tumor cells for subsequent RNA analysis in vitro diagnostics. It