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SN EN ISO 10993-11 : 2009

SN EN ISO 10993-11 : 2009

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

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

Withdrawn date

01-11-2018

Superseded by

SN EN ISO 10993-11 : 2018

Published date

12-01-2013

Publisher

Swiss Standards

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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.

DevelopmentNote
Supersedes SN 119800. (06/2006)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Withdrawn
SupersededBy
Supersedes

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