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UNE-EN ISO 10993-4:2018/A1:2025  UNE

Status: Vigente/ 2025-10-22

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)

UNE-EN ISO 10993-5:2009/A11:2025  UNE

Status: Vigente/ 2025-10-22

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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

Status: Current/2024-05-22

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

Status: Vigente/ 2022-01-19

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 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 10993-4:2017  UNE

Status: Anulada/ 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 22442-1:2016  UNE

Status: Anulada/ 2022-01-19

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

UNE-EN ISO 22442-2:2016  UNE

Status: Anulada/ 2022-01-19

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)

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 10993-10:2013  UNE

Status: Anulada/ 2023-10-18

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

UNE-EN ISO 10993-12:2013  UNE

Status: Anulada/ 2022-02-16

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

UNE-EN ISO 14155:2012  UNE

Status: Anulada/ 2021-09-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

UNE-EN ISO 14155:2011  UNE

Status: Anulada/ 2012-02-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

UNE-EN ISO 10993-10:2011  UNE

Status: Anulada/ 2013-11-20

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

UNE-EN ISO 10993-10:2009 ERRATUM:2010  UNE

Status: Anulada/ 2011-03-24

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

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 10993-1:2010/AC:2010  UNE

Status: Anulada/ 2021-10-06

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)

UNE-EN ISO 10993-16:2010  UNE

Status: Anulada/ 2018-05-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

UNE-EN ISO 10993-9:2010  UNE

Status: Anulada/ 2022-05-25

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

UNE-EN ISO 10993-1:2010  UNE

Status: Anulada/ 2021-10-06

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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 14155-2:2009  UNE

Status: Anulada/ 2011-10-05

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

UNE-EN ISO 14155-1:2009  UNE

Status: Anulada/ 2011-10-05

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

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 10993-15:2009  UNE

Status: Anulada/ 2024-01-17

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

UNE-EN ISO 10993-3:2009  UNE

Status: Anulada/ 2015-05-06

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

UNE-EN ISO 10993-4:2009  UNE

Status: Anulada/ 2017-11-15

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

UNE-EN ISO 10993-6:2009  UNE

Status: Anulada/ 2017-10-25

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

UNE-EN ISO 10993-9:2009  UNE

Status: Anulada/ 2010-06-09

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

UNE-EN ISO 10993-10:2009  UNE

Status: Anulada/ 2011-02-23

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006)

UNE-EN ISO 10993-11:2009  UNE

Status: Anulada/ 2018-12-26

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

UNE-EN ISO 10993-12:2009  UNE

Status: Anulada/ 2013-02-27

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

UNE-EN ISO 10993-13:2009  UNE

Status: Anulada/ 2010-11-17

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)