NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

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

Abstract

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.

Begin

2024-10-31

WI

00206112

Planned document number

prEN ISO 10993-13 rev

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  

previous edition(s)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
2010-06

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Contact

Dr.

Susann Minkwitz

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