Title Of Document
Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
Abstract
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products. Although these materials are intended for biomedical applications, the biological activity of these degradation products is not addressed in this part of ISO 10993.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 10993-14:2001
ICS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
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 14: Identification and quantification of degradation products from ceramics