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Number of results 201
UNE-EN ISO 10993-17:2024 UNE
Status: Current/2024-05-22
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 UNE
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 UNE
Status: Vigente/ 2024-01-17
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
UNE-EN ISO 10993-10:2023 UNE
Status: Vigente/ 2023-10-18
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN ISO 10993-2:2023 UNE
Status: Vigente/ 2023-07-12
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
UNE-EN ISO 20776-2:2022 UNE
Status: Vigente/ 2022-09-21
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 ISO 10993-7:2009/A1:2022 UNE
Status: Vigente/ 2022-07-27
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 UNE
Status: Vigente/ 2022-05-25
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
UNE-EN ISO 10993-12:2022 UNE
Status: Vigente/ 2022-02-16
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
UNE-EN ISO 22442-1:2022 UNE
Status: Vigente/ 2022-01-19
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
UNE-EN ISO 22442-2:2022 UNE
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 UNE
Status: Vigente/ 2021-10-13
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN ISO 10993-1:2021 UNE
Status: Vigente/ 2021-10-06
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 UNE
Status: Vigente/ 2021-09-22
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN ISO 20776-1:2021 UNE
Status: Vigente/ 2021-02-10
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 UNE
Status: Vigente/ 2021-01-20
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
UNE-EN 13641:2002 UNE
Status: Vigente/ 2020-02-20
Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
UNE-EN ISO 10993-11:2018 UNE
Status: Vigente/ 2018-12-26
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-16:2018 UNE
Status: Vigente/ 2018-05-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
UNE-EN ISO 10993-4:2018 UNE
Status: Vigente/ 2018-01-24
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
UNE-EN ISO 10993-6:2017 UNE
Status: Vigente/ 2017-10-25
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
UNE-EN ISO 10993-3:2015 UNE
Status: Vigente/ 2015-05-06
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
UNE-EN ISO 10993-13:2010 UNE
Status: Vigente/ 2010-11-17
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
UNE-EN ISO 10993-7:2009/AC:2010 UNE
Status: Vigente/ 2010-02-24
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
UNE-EN ISO 10993-5:2009 UNE
Status: Vigente/ 2009-12-09
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN ISO 10993-14:2009 UNE
Status: Vigente/ 2009-09-09
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
UNE-EN ISO 10993-7:2009 UNE
Status: Vigente/ 2009-06-03
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
UNE-EN ISO 22442-3:2008 UNE
Status: Vigente/ 2008-06-25
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
ISO 10993-17:2023 ISO
Status: Published/ 2023-09-13
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
ISO/TS 11796:2023 ISO
Status: Published/ 2023-07-27
Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
ISO/TR 10993-55:2023 ISO
Status: Published/ 2023-02-06
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 10993-2:2022 ISO
Status: Published/ 2022-11-03
Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-18:2020/Amd 1:2022 ISO
Status: Published/ 2022-05-11
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 17593:2022 ISO
Status: Published/ 2022-03-11
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 20776-2:2021 ISO
Status: Published/ 2021-12-23
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 10993-10:2021 ISO
Status: Published/ 2021-11-16
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO/TR 21582:2021 ISO
Status: Published/ 2021-07-12
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
ISO 10993-23:2021 ISO
Status: Published/ 2021-01-20
Biological evaluation of medical devices — Part 23: Tests for irritation
ISO 10993-12:2021 ISO
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 22442-1:2020 ISO
Status: Published/ 2020-09-15
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
ISO 22442-2:2020 ISO
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
ISO 14155:2020 ISO
Status: Published/ 2020-07-28
Clinical investigation of medical devices for human subjects — Good clinical practice
ISO/TS 10993-19:2020 ISO
Status: Published/ 2020-03-12
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-18:2020 ISO
Status: Published/ 2020-01-13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-7:2008/Amd 1:2019 ISO
Status: Published/ 2019-12-09
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
ISO 10993-15:2019 ISO
Status: Published/ 2019-11-26
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-9:2019 ISO
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ISO 20776-1:2019 ISO
Status: Published/ 2019-06-05
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/TS 21726:2019 ISO
Status: Published/ 2019-02-01
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
ISO 10993-1:2018 ISO
Status: Published/ 2018-08-17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
