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Codes & Standards - Purchase

ISO 10993-10:2021

Biological evaluation of medical devices — Part 10: Tests for skin sensitization
  • English, French
  • Published in 2021
  • Published by ISO
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ISO 10993-11:2017

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
  • English, French
  • Published in 2017
  • Published by ISO
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ISO 10993-12:2021

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
  • English, French
  • Published in 2021
  • Published by ISO
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ISO 10993-13:2010

Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
  • English, French
  • Published in 2010
  • Published by ISO
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ISO 10993-14:2001

Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
  • English, French
  • Published in 2001
  • Published by ISO
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ISO 10993-15:2000

Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
  • English, French
  • Published in 2000
  • Published by ISO
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ISO 10993-16:2017

Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
  • English, French
  • Published in 2017
  • Published by ISO
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ISO 10993-18:2020

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
  • English, French
  • Published in 2020
  • Published by ISO
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ISO 10993-18:2020/Amd 1:2022

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
  • English, French
  • Published in 2022
  • Published by ISO
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ISO 10993-1:2018

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • English, French
  • Published in 2018
  • Published by ISO
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ISO 10993-23:2021

Biological evaluation of medical devices — Part 23: Tests for irritation
  • English, French
  • Published in 2021
  • Published by ISO
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ISO 10993-2:2022

Biological evaluation of medical devices — Part 2: Animal welfare requirements
  • English, French
  • Published in 2022
  • Published by ISO
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ISO 10993-3:2014

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • English, French
  • Published in 2014
  • Published by ISO
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ISO 10993-4:2017

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
  • English, French
  • Published in 2017
  • Published by ISO
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ISO 10993-5:2009

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
  • English, French
  • Published in 2009
  • Published by ISO
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ISO 10993-6:2016

Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
  • English, French
  • Published in 2016
  • Published by ISO
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ISO 10993-7:2008

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
  • English, French
  • Published in 2008
  • Published by ISO
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ISO 10993-7:2008/Amd 1:2019

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
  • English, French
  • Published in 2019
  • Published by ISO
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ISO 10993-7:2008/Cor 1:2009

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1
  • English, French
  • Published in 2009
  • Published by ISO
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ISO 10993-9:2009

Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
  • English, French
  • Published in 2009
  • Published by ISO