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1、 Reference number ISO 16428:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 16428 First edition 2005-04-01 Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices Implants chirurgicaux Solutions dessai et condit
2、ions environnementales pour les essais statiques et dynamiques de corrosion sur les matriaux et dispositifs mdicaux implantables Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 0
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6、em relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfil
7、m, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005
8、All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16428:2005(E) ISO 2005
9、All rights reserved iii Contents Page Forewordiv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Significance and application . 2 4.1 Significance of test solution 2 4.2 Application. 2 5 Environmental testing conditions. 3 5.1 Test solution 3 5.2 Testing temperature
10、3 5.3 pH value . 3 5.4 Aeration 3 5.5 Volume of test solution 3 5.6 Circulation of the solution . 4 5.7 Test chamber. 4 6 Test specimens . 4 7 Evaluation and reporting 4 7.1 Evaluation of test results . 4 7.2 Test report . 4 Annex A (informative) Additional test solutions . 6 Annex B (informative) C
11、onsiderations for surface preparation and test evaluation. 7 Bibliography . 8 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networking permitted
12、without license from IHS -,-,- ISO 16428:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
13、 ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborate
14、s closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards
15、. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this
16、 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16428 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. Copyright International Organization for Standardization Provi
17、ded by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16428:2005(E) ISO 2005 All rights reserved v Introduction In many instances testing of medical devices an
18、d materials in a physiological environment is highly desirable for scientific purposes and development work as well as for the assessment of the performance of surgical implants and devices. The application of original physiological fluids is often difficult because of the rapid deterioration of suc
19、h media. The application of artificial media is common, but there is the disadvantage that the compositions vary widely and testing results are often not comparable. This International Standard specifies basic reproducible environmental conditions using a test fluid of isotonic sodium chloride (NaCl
20、) solution. This solution is appropriate because it is used for injections and irrigation in surgery and has an ion content similar to that of human body fluids. Of particular importance are the chloride (Cl) ions because the corrosion resistance of most metals is very sensitive to them. Correspondi
21、ngly, the isotonic NaCl solution is already widely used in the testing of medical devices. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networki
22、ng permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- INT
23、ERNATIONAL STANDARD ISO 16428:2005(E) ISO 2005 All rights reserved 1 Implants for surgery Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices 1 Scope This International Standard specifies standard environmental conditions fo
24、r 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
25、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,
26、 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
27、outside the scope of this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including a
28、ny amendments) applies. ISO 3696, Water for analytical laboratory use Specification and test methods 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 corrosion fatigue testing assessment of corrosion fatigue behaviour where cyclic loading test
29、s are carried out in an aqueous test solution which is related to the human physiological environment NOTE The test solution may either cause visible corrosion effects and/or acceleration of the fatigue process. 3.2 environmental testing conditions conditions under which a sample (specimen) is teste
30、d including the testing fluid, temperature, aeration, the pH, and the volume ratio and exchange of the fluid 3.3 isotonic sodium chloride solution aqueous solution of sodium chloride (0,9 % NaCl mass fraction) which provides the same osmotic pressure in living tissues as the physiological fluid (blo
31、od serum) NOTE In surgical applications, it prevents the collapse of tissues and serves as an infusion solution. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo re
32、production or networking permitted without license from IHS -,-,- ISO 16428:2005(E) 2 ISO 2005 All rights reserved 3.4 Ringers solution isotonic aqueous solution of NaCl with additional compounds which are constituents of the human body fluids (blood serum) NOTE See also Annex A. 3.5 static and dyna
33、mic test mechanical set-up of the test within the context of this International Standard NOTE This does not refer to electrochemical conditions. 4 Significance and application 4.1 Significance of test solution The described environmental conditions are intended for applications where a testing envir
34、onment for metallic medical devices or materials is required that relates to physiological conditions. The isotonic NaCl solution is used for injections 3 and for flushing and cleaning in surgery. Its ion concentration is similar to that of human body fluids. Of particular significance are the Cl io
35、ns because they have corrosive effects on metals, in particular on such metals and alloys which form passive films that protect against corrosion. 4.2 Application 4.2.1 General The test conditions described are applicable for static and dynamic mechanical tests to assess the potential susceptibility
36、 to corrosion effects related to the physiological environment. 4.2.2 Testing under static conditions The environmental conditions described are suitable for static immersion tests to study, for example, special corrosion effects such as pitting or crevice corrosion, leaching, or the performance of
37、special surface treatments. Such tests may include uniform mechanical loading. NOTE On highly corrosion resistant metallic implant materials, no visible surface deterioration might be detectable in purely static immersion tests. The environmental conditions described might show only effects under mo
38、re stringent polarized conditions or mechanical loading and/or dynamic conditions. 4.2.3 Testing under loaded dynamic conditions The environmental conditions described are added to mechanical test arrangements which are commonly carried out in air. They are applied, for example, in fatigue testing t
39、o assess the susceptibility to corrosion fatigue, or in selected fretting and friction tests where corrosion and wear effects are of concern. This International Standard is not applicable to typical articulating joint simulator tests and aspects particular to the dental field nor that attempt to rep
40、licate the tribological properties of body fluids, such as those used in wear studies. In short-term handling tests (e.g. clamping), where friction or fretting are of concern, the test solution(s) (5.1) may be employed while some of the other environmental conditions (Clause 5) are neglected dependi
41、ng on the issue. 4.2.4 Electrochemical studies In general, the environmental conditions described are applicable to electrochemical testing. However, depending on the type of tests some more stringent conditions may be required by certain test protocols. Copyright International Organization for Stan
42、dardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 08:02:22 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16428:2005(E) ISO 2005 All rights reserved 3 5 Environmental testing conditions 5.1 Test
43、 solution For the preparation of an isotonic aqueous 0,9 % (mass fraction) sodium chloride solution, 9 g of NaCl of analytical quality is added to purified water in accordance with ISO 3696. This results in 1 000 ml of test solution (for additional information see Reference 3). If a test solution ot
44、her than the isotonic NaCl has been used in the testing, this shall be reported indicating some rationale. There may be specific reasons to use a modified isotonic NaCl solution for the intended testing, for example a phosphate-buffered solution. The latter would have to be applied with technical ca
45、re. There are various compositions known as “Ringers solutions” which contain additions that are constituents of the body fluids; in Annex A, a common composition is given under A.1. Under A.2, a modified solution with low pH is given, in case more stringent testing conditions are desired. Additiona
46、l acceptable test solutions related to the human physiological environment include those identified in ASTM F 2129:2003, Annex X2 8. 5.2 Testing temperature During the test, the temperature of the solution is kept stable thermostatically at (37 1) C. 5.3 pH value The test solution has nearly a neutr
47、al pH value. During long-term testing the pH value shall be recorded on a regular basis. Smaller shifts of the pH may be caused by air (CO2). Significant changes of the pH value may indicate deterioration of the testing solution. This may be caused by degradation products (such as corrosion products
48、 or wear debris) from the test samples or possibly from parts of the test chamber. As soon as the test solution deteriorates, for example indicated by shifting of the pH or by discoloration, the test solution shall be exchanged and the test chamber washed out prior to the refill. If the degradation products and/or their effects are to be investigated, the test solution may remain unchanged, but this should be recorded and an explanatory note should be included in the test report.