Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-10-2005

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Significance and application
  4.1 Significance of test solution
  4.2 Application
5 Environmental testing conditions
  5.1 Test solution
  5.2 Testing temperature
  5.3 pH value
  5.4 Aeration
  5.5 Volume of test solution
  5.6 Circulation of the solution
  5.7 Test chamber
6 Test specimens
7 Evaluation and reporting
  7.1 Evaluation of test results
  7.2 Test report
Annex A (informative) Additional test solutions
Annex B (informative) Considerations for surface
                      preparation and test evaluation
Bibliography

Provides standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices.

This International Standard specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The test conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered. Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests.

Typical articulating joint simulator tests and aspects particular to the dental field are not considered by this International Standard. Solutions that attempt to replicate the tribological properties of body fluids, such as those used in wear studies, are outside the scope of this International Standard.

Committee	CH/150/1
DevelopmentNote	Supersedes 03/305239 DC. (06/2005)
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current
Supersedes	03/305239 DC : DRAFT APR 2003

Standards	Relationship
ISO 16428:2005	Identical

ISO 11845:1995	Corrosion of metals and alloys General principles for corrosion testing
ISO 8044:2015	Corrosion of metals and alloys Basic terms and definitions
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods

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BS ISO 16428:2005

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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