AS ISO 10993.10-2003
Withdrawn
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English
06-30-2003
06-30-2017
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.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 5369 8
|
| Pages |
49
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 10993-10:2002 | Identical |
First published as AS ISO 10993.10-2002.
Second edition 2003.
| AS ISO 8009-2009 | Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
| AS 2869-2008 | Tampons - Menstrual |
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