Logo

ISO 10993-14:2001

Current Revision

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

$81.00

$81.00

$137.70


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


Document Preview Not Available...

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.


SDO ISO: International Organization for Standardization
Document Number ISO 10993
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Publish Date Document Id Type View
Not Available ISO 10993-14:2001 Revision