ISO-10993-14 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

ISO-10993-14 - 1ST EDITION - CURRENT -- See the following: ISO/DIS-10993-14

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:

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.




To find similar documents by classification:

11.100 (Laboratory medicine)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO 10993-14:2001

Revision Level




Publication Date

Nov. 15, 2001

Committee Number

ISO/TC 194