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NBN EN ISO 10993-11 : 2009

Current

Current

The latest, up-to-date edition.

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

Published date

12-01-2013

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Committees responsible
National foreword
Foreword
Introduction
Method
1 Scope
2 Normative references
3 Definitions
4 Test sample requirements and recommendations
5 Method for extraction from medical devices
6 Selection of test procedures for systemic toxicity
7 Selection of test procedures for pyrogenicity
8 Assessment of results
9 Test report
Annex
A (informative) Addresses
ZA (normative) Normative references to international
    publications with their relevant European
    publications

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.

DocumentType
Standard
PublisherName
Belgian Standards
Status
Current

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