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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-04-2018

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Committee	TC 194
DocumentType	Standard
Pages	50
ProductNote	This standard also referce to ISO 10993, ASTM F619-03, AAMI/ST72 The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 10993-11:2009