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BS EN ISO 10993-14:2009

Current
Current

The latest, up-to-date edition.

Biological evaluation of medical devices Identification and quantification of degradation products from ceramics
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2009

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.

Committee
CH/194
DevelopmentNote
Supersedes 99/565056 DC. (01/2002)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

ISO 5017:2013 Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO 3310-1:2016 Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth
ISO 6872:2015 Dentistry Ceramic materials
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 9693:1999 Metal-ceramic dental restorative systems
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ASTM C 92 : 1995 TEST METHODS FOR SIEVE ANALYSIS AND WATER CONTENT OF REFRACTORY MATERIALS

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