BS EN ISO 10993-14:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test procedures
  4.1 Principle
  4.2 Testing of dental devices
  4.3 General testing techniques
  4.4 Extreme solution test
  4.5 Simulation solution test
5 Analysis of filtrate
  5.1 General
  5.2 Choice of chemicals or elements to be analysed
  5.3 Sensitivity of the analysis method
6 Test report
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on Medical Devices

Defines 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.

This part of ISO10993 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 ISO10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first.

This part of ISO10993 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 ISO6872 and ISO9693 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 ISO10993 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 ISO10993.