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Number of results 439
UNE-EN 13697:2024
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas without mechanical action - Test method and requirements without mechanical action (phase 2, step 2)
UNE-EN ISO 10993-17:2024
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
UNE-EN ISO 10993-18:2021/A1:2024
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
UNE-EN ISO 10993-15:2024
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
UNE-CEN/TR 18010:2023
Chemical disinfectants and antiseptics - Information on the preparation of spores and determination/exclusion of sporistatical activity (Endorsed by Asociación Española de Normalización in December of 2023.)
UNE-EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN ISO 10993-2:2023
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
UNE-EN ISO 13132:2023
Laboratory glassware - Petri dishes (ISO 13132:2023) (Endorsed by Asociación Española de Normalización in June of 2023.)
UNE-EN 14885:2023
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
UNE-CEN/TR 17825:2022
Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015 (Endorsed by Asociación Española de Normalización in October of 2022.)
UNE-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 susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)
UNE-EN 12353:2022
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
UNE-EN ISO 10993-7:2009/A1:2022
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
UNE-EN ISO 10993-9:2022
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
UNE-EN 17387:2022
Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
UNE-EN ISO 10993-12:2022
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
UNE-EN ISO 22442-1:2022
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
UNE-EN ISO 22442-2:2022
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
UNE-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-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 2018-10)
UNE-EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN 60601-1-2:2015/A1:2021
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)
UNE-EN ISO 20776-1:2021
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)
UNE-EN ISO 10993-18:2021
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)