ISO-10993-13 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO-10993-13 - 2ND EDITION - CURRENT
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ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that 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. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers.

ISO 10993‑13:2010 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 or biological factors such as enzymes, other proteins and cellular activity.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-13:2010

Revision Level

2ND EDITION

Status

Current

Publication Date

June 15, 2010

Committee Number

ISO/TC 194