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ISO 10993-11 : 2017

M00023450

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ISO 10993-11 : 2017

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

International Organization for Standardization

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Abstract

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

Scope

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

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Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 194
Supersedes
  • ISO/DIS 10993-11 : 60.00 (2017)
  • ISO 10993-11 : 2006