Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (First revision) (ISO 10993-13:2010, IDT)
This Malaysian Standard 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.
This Malaysian Standard 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. This Malaysian Standard considers only non-resorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers.
This Malaysian Standard 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 e
Published
• (none) / (none) / MS ISO 10993-13:2005
PDF
17/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
