11.100.20: Biological evaluation of medical devices
Search Results
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MOST RECENT
ISO 10993-7:2008/Amd1:2019
- Amendment 1: Applicability of allowable limits for neonates and infants
Amendment by International Organization for Standardization, 12/01/2008.
Languages: English
- MULTI-USER
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MOST RECENT
ISO 10993-18:2020/Amd1:2022
- Amendment 1: 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
Amendment by International Organization for Standardization, 05/01/2022.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/TS 21726:2019
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
standard by International Organization for Standardization (Technical Standard), 02/01/2019.
Languages: English
- MULTI-USER
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MOST RECENT
ISO/TS 20993:2006 [ Withdrawn ]
Biological evaluation of medical devices - Guidance on a risk-management process
standard by International Organization for Standardization (Technical Standard), 08/01/2006.
Languages: English
- MULTI-USER
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HISTORICAL
ISO/TR 15499:2012
This document has been replaced. View the most recent version.
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
standard by International Organization for Standardization (Technical Report), 07/15/2012.
Languages: English
Historical Editions: ISO/TR 15499:2016
- MULTI-USER
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MOST RECENT
ISO/TR 15499:2016
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
standard by International Organization for Standardization (Technical Report), 12/01/2016.
Languages: English
Historical Editions: ISO/TR 15499:2012
- MULTI-USER
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HISTORICAL
ISO 10993-10:2002
This document has been replaced. View the most recent version.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
standard by International Organization for Standardization, 09/01/2002.
Languages: English
Historical Editions: ISO 10993-10:2021, ISO 10993-10:2010
- MULTI-USER
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MOST RECENT
ISO 10993-10/Amd1:2006
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization - Amendment 1
Amendment by International Organization for Standardization, 07/15/2006.
Languages: English
- MULTI-USER
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HISTORICAL
ISO 10993-10:2010
This document has been replaced. View the most recent version.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
standard by International Organization for Standardization, 08/01/2010.
Languages: English
Historical Editions: ISO 10993-10:2021, ISO 10993-10:2002
- MULTI-USER
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MOST RECENT
ISO 10993-10:2021
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
standard by International Organization for Standardization, 11/15/2021.
Languages: English
Historical Editions: ISO 10993-10:2010, ISO 10993-10:2002
- MULTI-USER
