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AS ISO 10993.10-2003

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Biological evaluation of medical devices Tests for irritation and delayed type hypersensitivity
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

06-30-2017

Language(s)

English

Published date

01-01-2003

Publisher

Standards Australia

Preview

Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitvity, including pretest considerations, details of the test procedures, and key factors for the interpretation of the results.

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.This part of ISO 10993 includesa) pretest considerations,b) details of the test procedures, andc) key factors for the interpretation of the results.Instructions are given in annex A for the preparation of materials specifically in relation to the above tests.Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.

Committee
HE-012
DocumentType
Standard
ISBN
0 7337 5369 8
Pages
49
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

Standards Relationship
ISO 10993-10:2002 Identical

First published as AS ISO 10993.10-2002.Second edition 2003. First published as AS ISO 10993.10-2002. Second edition 2003.

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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