BH GSO ISO 10993-14:2017
ISO 10993-14:2001
Bahraini Standard
Current Edition
·
Approved on
21 June 2017
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
BH GSO ISO 10993-14:2017 Files
English
11 Pages
Current Edition
Reference Language
BHD
30.34
BH GSO ISO 10993-14:2017 Scope
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.
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023
Bahraini Standard
Personal Care and Baby Wet Wipes
BH GSO 2241:2023
GSO 2241:2023
Bahraini Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
Recently Published from Health Sector
GSO ISO 24806:2026
ISO 24806:2023
Gulf Standard
Recreational diving services — Requirements for rebreather diver training — Decompression diving to 60 m
GSO ISO 23223:2026
ISO 23223:2025
Gulf Standard
Alpine ski boots with improved walking soles — Interface with alpine ski-bindings — Requirements, test methods and marking
GSO ASTM F2236:2026
ASTM F2236:24
Gulf Standard
Standard Consumer Safety Specification for Soft Infant and Toddler Carriers
GSO ISO 21103:2026
ISO 21103:2014
Gulf Standard
Adventure tourism — Information for participants