AS ISO 10993.12-2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 - Sample preparation and reference materials
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2017
English
01-01-2004
Important note : Users cannot be edited or removed once added to your Multi user PDF.Specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with other AS ISO 10993 series Standards. The Standard is identical to, and has been reproduced from, ISO 10993-12:2002.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 6226 3
|
| Pages |
15
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series.Specifically, this part of ISO 10993 addresses:- test material selection;- selection of representative portions from a device;- test sample preparation;- experimental controls;- selection of and requirements for reference materials; and- preparation of extracts.The applicability of this part of ISO 10993 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
| Standards | Relationship |
| ISO 10993-12:2002 | Identical |
| ISO 10993-12:2007 | Identical |
First published as AS ISO 10993.12-2002.
Second edition 2004.
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