AS ISO 10993.13-2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 - Identification and quantification of degradation products from polymeric medical devices
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2017
English
01-01-2002
Important note : Users cannot be edited or removed once added to your Multi user PDF.Provides guidance on requirements for the design of tests to identify and quantify degradation products from finished polymeric medical devices ready for clinical use.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 4716 7
|
| Pages |
10
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer.This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation.The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1 and ISO 14538.Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.
| Standards | Relationship |
| ISO 10993-13:1998 | Identical |
First published as AS ISO 10993.13-2002.
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