Overview

This standard specifies 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. It 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. This standard describes only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the medical devices induced during its intended use by mechanical stress, wear, electromagnetic radiation or biological factors, such as enzymes, other proteins and cellular activity. The standard applies to the manufacturers of the medical devices and test laboratories. The European Standard has been prepared by ISO/TC 194 "Biological evaluation of medical devices" (secretariat: Germany), in collaboration with CEN/TC 206 "Biological evaluation of medical devices" with the significant participation of German experts. At DIN the responsible Working Committee is NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") of Optics and Precision Mechanics Standards Committee NAFuO.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices