Technical Information Report
AAMITIR17:2008
Compatibilityofmaterialssubjectto sterilization
Objectivesand usesofAAMIstandardsand remendedpractices
It is most important that the objectives and potential uses of an AAMI product standard or remended practice are clearlyprogram derive from AAMI's overall mission: the advancement of understood. The objectives of AAMI's technical developmentmedical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of curenttechnologies to patient care and (2) the encouragement of new technologies. It is AAMl's view that standards and remendedpractices can contribute significantly to the advancement of medical instrumentation provided that they are drafed withattention to these objectives and provided that arbitrary and restrictive uses are avoided.
manufacturer the information that should be provided with or on A voluntary standardf for a mefical device remends to thethe product basic safety and performance criteria that should be considered in qualifying the device for clinical use and themeasurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or toSome standards emphasize the information that should be providedwith the device including perfommance characteristis instructions for use warnings and precautions and other data consideredimportant in ensuring the safe and effective use of the device in the clinical environment.Remendingthe disclosure ofspecialized test methods to facilitate unifomity in reporting; performance characteristics often necessitates the development ofreaching consensus on these tests can represent a considerable part of mittee work. When a drafting mittee determines thatclinical concerns warrant the establishment of minimum safety and performance criteria referee tests must be provided and the reasonsfor establishing the criteria must be documented in the rationale.
A remendled practice provides guidelines for the use care and/or processing of a medical device or system. A remended practice does not address device performance per se but ratherprocedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained.
manufacturer it may also be of value to the potential purchaser or Although a device standard is primarily directed to theuser of the device as a frame of reference for device evaluation. Similarly even though a remended practice is usually orientedtowards healthcare professionals it may be useful to the manufacturer in better understanding the environment in which amedical device will be used. Also some remended practices while not addressing device performance criteria provideguidelines to industrial personnel on such subjeets as sterilization processing methods of collecting data to establish safety andefficacy human engineering and other processing or evaluation techniques; such guidelines may be useful to health careprofessionals in understanding industrial practices.
In detemining whether an AAMI standand or remendedpractice is relevant to the specific needs of a potential user of the document several important concepts must be recognized:
Jo Aopenifau puuo q poqdope ae Aaq *ssmoo jo ssaun) All AAMI standards and remended peactices are vohuntaryprocurement authorities). The application of a standard or remended practice is solely within the discretion andprofessional judgment of the user ofthe document.
collective expertise of a mittee of health care professonals and Each AAMI standard or remended practice reflects theindustral representatives whose work has been reviewed nationally (and sometimes intermationally). As such the consensusremendations embodied in a standard or remended practice are intended to respond to clinical needs and ultimately to helpensure patient safety. A standard or recoemmended practice is limited however in the sense that it responds generally tospecific situtions. A standard er recmended practice is an o maa aq see ou m peq suopus pe ss paauadimportant referemce in responsible decision-making but it should never replace responsible decision-making.
years) a standard or remended practice is necessarily a static Despite periodic review and revision (at least once every fivedocument applied to a dynamic technology. Therefore a standards user must carefully review the reasons why the document wasprovisions. This review will reveal whether the document remains initially developed and the specific rationale for each of itsrelevant to the specific needs of the user.
Particular care should be taken in applying a product standardto existing dvics an equipment and n applying a remmendd practice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard existing cquipment. No single source of infomation will serve to professional judgment must be used in applying these criteria toidentify a particular product as “unsafe”. A voluntary standard can be used as one resource but the ultimate decision as to productsafety and efficacy must take into account the specifics of its utilization and of course cost-benefit considerations. Similarly aremended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm.Again the rationale acpanying each AAMI standard and remended practice is an excellent guide to the reasoning anddata underlying its provision.
In summary a standard or remended practice is trulyuseful only when it is used in conjunction with other sources of information and policy guidance and in the context of professionalexperience and judgment.
INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES
Requests for interpretations of AAMI standards and remendedpractices must be made in writing to the AAMI Vice President Standards Policy and Programs. An official interpretation must beapproved by leter ballo of the originating mitee and subsequently reviewed and approved by the AAMI StandardsBoard. The interpretation will bee official and representation of the Association only upon exhaustion of any appeals and uponpublication of notice of interpretation in the *Standands Monitor" section of the AAMI News. The Association for the Advancementof Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or remendedpractice which has not been developed and municated in accordance with this procedure and which is not published byappropriate notice as an official interpretation in the AAMI News.
Compatibilityofmaterialssubjecttosterilization
Approved 26 August 2008 by Association for the Advancement of Medical Instrumentation
Abstract:
ceramics and metals in health care products that are sterilized by the following modalities: a)e) hydrogen peroxide; and f ozone. Annexes adress the specific sterilization modaity concems.
Keywords:
material qualification sterilization
AAMl Technical Information Report
A technical information report (TIR)isa publication of the Association for the Advancement of MedicalInstrumentation (AAMl) Standards Board that addresses a particular aspect of medical technoiogy-
Although the material presented in a TIR might need further evaluation by experts releasing the information is valuable because the industry and the professions have an immediate need for it.
A TIR differs markedly from a standard or remended practice and readers should understand the differencesbetween these documents.
resolution of all ments. This process of consensus is supervised by the AAMI Standards Board and in the case Standards and remended practices are subject to a formal process of mittee approval public review andof American National Standards by the American National Standards Institute.
A TIR is not subject tothe same formal approval process as a standard. However a TIR is approved for distribution by a technical mittee and the AAMI Standards Board.
Another difference is that although both standards and TIRs are periodically reviewed a standard must be actedon-reaffimed revised or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TiR AAMI consults with a technical mite about five years affer the publication date (andperiodically thereafter) for guidance on whether the document is stillusefulthat is to check that the information is relevant or of historical value. If the information is not useful the TIR is removed from circulation.
A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or remended practice or because achieving consensus is extremely difficult or unlikely. Unlike a standard a TIRpermits the inclusion of differing viewpoints on technical issues.
evolvingfeldortechnologyreaders are cautioned to ensure that theyhave also consideredinfomation thatmightb CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidlymore recent than this document.
All standards remended practices technical information reports and other types of technical documents developed by AAMI are voluntary and their application is solely within the discretion and professional judgment of theor procurement authorities in which case the adopting agency is responsible for enforcement of its rules and user of the document. Occasionally voluntary technical documents are adopted by government regulatory agenciesregulations.
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Contents
Glossary of equivalent standards.Committe representation. viForeword. ..x1 Scope. Definitions symbols and abbreviations. .12 3 Selection of materials-Guidance.. .3 13.1 3.2 General. Guidance specific to diferent sterilization modalies. .33.2.1 Radiation sterilization.... .43.2.2 3.2.3 EO sterilization.. Moist heat (steam) sterilization 5 .53.2.5 3.2.4 Dry heat steriization Hydrogen peroxide sterilization.... .6 .73.2.6 3.3 Comparison of materials patibility Ozone sterilization. ..7 .74 Manufacturing process and design considerations..4.1 4.2 Impact of processing versus impact of sterlization. General.. .11 -124.2.1 4.3 Processing considerations for injection molding . Product design considerations. ...13 .135 Material testing. 145.1 5.2 Definifion of requirements for product functionalty Definition of worse-case sterilization processing conditions .155.2.1 General. .155.2.2 5.3 Product functionality testing. Considerations for processing condlitions unique to radiation sterilization .. .15 .165.4 5.4.1 Material biopatibility.. General.. .185.4.2 Biopatibity concems regarding sterilant residuals ..96 6.1 Background. Accelerated aging programs. -20 .206.2 ouepn5 maN .20Annex A Radiation sterilization-Material patibility fundamentals . A.1 Background. .21 .21A.2 A.3 Steriliztionproess variationsandparamters Material patibity - -21 .21A.3.1 A.3.2 General. Specific materials.. .25 .21A.4 References. .32Annex B EO sterilization-Material patibility fundamentals B.1 Background..B.2.1 B.2 Sterilization process variations and parameters General.B.23 B.2.2 Process variations. 34B.3 Material patibity Process parameters. 35 35B.3.1 General. .35
