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BS EN ISO 10993-15:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

24-05-2023

Language(s)

English

Published date

31-07-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
  4.1 General
  4.2 Prerequisites
5 Reagent and sample preparation
  5.1 Sample documentation
  5.2 Test solution (electrolyte)
  5.3 Preparation of test samples
6 Electrochemical tests
  6.1 Apparatus
  6.2 Sample preparation
  6.3 Test conditions
  6.4 Potentiodynamic measurements
  6.5 Potentiostatic measurements
7 Immersion test
  7.1 Apparatus
  7.2 Sample preparation
  7.3 Immersion test procedure
8 Analysis
9 Test report
Annex A (informative) - Schematic diagram of the
        electrochemical measuring circuit
Annex B (informative) - Schematic drawing of an
        electrolytic cell
Annex C (informative) - Examples of alternative
        electrolytes for the electrochemical tests
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on Medical Devices

Gives guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use.

This part of ISO10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This part of ISO10993 is not applicable to degradation products induced by applied mechanical stress. NOTE Mechanically induced degradation, such as wear, may be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered. Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (

Committee
CH/194
DevelopmentNote
Supersedes 97/564356 DC (05/2005)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
NFS 91 141 : 1997 BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 3585:1998 Borosilicate glass 3.3 Properties
ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 8044:2015 Corrosion of metals and alloys Basic terms and definitions
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 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

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