ICS 11.100
Laboratory medicine
Standards in This Category
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 EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
This document establishes a standardized methodology for evaluating the potential of medical devices to cause irritation upon contact with biological systems. It specifically addresses stimulation
LVS 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)
This document establishes a standardized framework for assessing the biological evaluation of medical devices, specifically focusing on the identification and quantitative determination of
LVS EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
This technical specification establishes a comprehensive framework for evaluating the potential of medical devices to cause skin sensitization in humans. Aligned with international methodologies, it
LVS EN ISO 10993-2:2023
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
This standard establishes specific requirements regarding animal welfare within the framework of biological evaluation for medical devices. It addresses the ethical considerations and practical
LVS EN ISO 10993-3:2015
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
This technical specification establishes a framework for evaluating the biological safety of medical devices, specifically addressing genotoxicity, carcinogenicity, and reproductive toxicity. It
LVS EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
This document establishes a standardized methodology for evaluating the cytotoxic potential of medical devices using in vitro test systems. It focuses specifically on assessing the effects of
LVS EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
This document outlines a technical specification developed to address the safety assessment of materials used in medical devices. It specifically focuses on the identification and quantification of
LVS EN ISO 10993-16:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
This technical specification addresses the assessment concepts regarding toxicokinetic evaluation of degradation products and leachables from medical devices. It establishes a structured framework
LVS EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
This document serves as a foundational guide within the field of medical device regulation, specifically addressing the biological evaluation process. It outlines the critical integration of risk
LVS 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)
This technical specification provides comprehensive guidance on identifying and quantifying potential degradation products from medical devices. It addresses the critical need to assess the
LVS EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
This document establishes the principles and methodologies for preparing samples and selecting reference materials used in the biological evaluation of medical devices. It provides a standardized
LVS EN ISO 10993-17:2023
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
This technical specification outlines the systematic approach for conducting toxicological risk assessments on individual components used in medical devices. It provides a detailed framework to
LVS EN ISO 10993-7:2009
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
This document establishes specific requirements for evaluating residual ethylene oxide following sterilization processes applied to medical devices. It serves as a crucial component within a broader
LVS EN ISO 10993-6:2017
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
This document outlines a specialized technical specification concerning the biological evaluation of medical devices, specifically addressing the assessment of local responses following the
LVS EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
This document establishes comprehensive requirements for the chemical characterization of materials within medical devices, specifically as an integral component of the risk management process. It
LVS EN ISO 10993-4:2018
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
This document outlines a specific technical guideline established to evaluate the biological response of medical devices when they interact with blood. It serves as a critical component within the
LVS EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
This technical specification establishes the fundamental principles and methodologies for assessing the systemic toxicity of medical devices during their biological evaluation process. It provides
LVS EN ISO 10993-14:2009
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
This document establishes comprehensive guidelines for the identification and quantification of degradation products derived from ceramics used in medical devices. It serves as a specialized
LVS EN ISO 13079:2011
Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
This specification outlines requirements for glass and plastic laboratory tubes utilized in measuring the erythrocyte sedimentation rate via the Westergren method. It aligns with international