ISO 10993-14:2001 PDF

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.

ISO 10993-14:2001 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 3310-1 Test sieves - Technical requirements and testing - Part 1: Test sieves of metal wire cloth*， 2016-08-01 Update
ISO 3696 Water for analytical laboratory use; Specification and test methods
ISO 5017 Dense shaped refractory products - Determination of bulk density, apparent porosity and true porosity*， 2013-01-01 Update
ISO 6474 Implants for surgery; ceramic materials based on high purity alumina
ISO 6872:1995 Dental ceramic

2001 ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics