Title Of Document
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.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 10993-13:2010
ICS
HS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
Member States
BN
ID
KH
LA
MM
MY
PH
SG
TH
VN
Date of harmonisation in ASEAN
16/10/2025
Date of Latest Review
Links :
Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices