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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Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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Withdrawn date

11-01-2018

Published date

01-12-2013

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Withdrawn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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