products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices

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1 ANSI/AAMI/ISO 20857:2010 document before making a purchasing decision. Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices Association for the Advancement of Medical Instrumentation

2 Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMI's technical development program derive from AAMI's overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMI's view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as "unsafe". A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. document before making a purchasing decision. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the "Standards Monitor" section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News.

3 American National Standard ANSI/AAMI/ISO 20857:2010 (Revision of ANSI/AAMI/ST63:2002) Sterilization This is a preview of edition health of an care AAMI guidance products document and Dry is heat Requirements document before the making development, a purchasing decision. validation and routine control of a sterilization process for medical devices Approved 8 December 2010 by Association for the Advancement of Medical Instrumentation Approved 30 December 2010 by American National Standards Institute, Inc. Abstract: Keywords: Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating medium. depyrogenation, process qualification, process monitoring, thermal, parametric release, validation, routine control

4 AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended 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 the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. document before making a purchasing decision. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr. Suite 301 Arlington, VA by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at or contact AAMI, 4301 N. Fairfax Drive Suite 301, Arlington, VA Phone: ; Fax: Printed in the United States of America ISBN

5 Contents Page Glossary of equivalent standards... v Committee representation... vii Background of US adoption of ISO 20857: ix Foreword... x Introduction... xi 1 Scope Inclusions Exclusions Normative references... 2 document before making a purchasing decision. 3 Terms and definitions Quality management system elements Documentation Management responsibility Product realization For... a complete copy of this AAMI document, Measurement, analysis contact and improvement AAMI at (877) Control of nonconforming product Sterilizing agent characterization Sterilizing agent Microbicidal effectiveness Material effects Environmental considerations Process and equipment characterization Process characterization Equipment characterization Product definition General Product safety and performance Packaging considerations Microbiological quality Product family Biological safety Process definition Validation General Installation qualification Operational qualification Performance qualification Additional sterilization systems Review and approval of validation Routine monitoring and control Routine control Routine monitoring... 21

6 10.3 Process monitoring locations Product release from sterilization/depyrogenation Maintaining process effectiveness General Recalibration Maintenance of equipment Requalification Assessment of change Annex A (informative) Guidance on the application of this International Standard Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) Annex C (informative) Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) Annex D (informative) Conservative process definition based on inactivation of reference microorganisms (overkill method) document before making a purchasing decision. Annex E (informative) Process development Bibliography... 61

7 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, (R)20xx indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO :2002/(R)2009 indicates that , originally approved and published in 2002, was reaffirmed without change in Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC :2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES :2005 and ANSI/AAMI ES :2005/A2:2010 ANSI/AAMI ES :2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 & 2 IEC :2007 ANSI/AAMI/IEC :2007 Identical IEC :2009 ANSI/AAMI/IEC :2009 Identical IEC :2010 ANSI/AAMI/IEC :2010 Identical IEC :2008 ANSI/AAMI/IEC :2008 Identical IEC :2009 ANSI/AAMI/IEC PREVIEW :2009 COPY Identical IEC :2009 ANSI/AAMI/IEC :2009 Identical IEC :2009 ANSI/AAMI/IEC :2009 Identical IEC :1998 This is a preview ANSI/AAMI edition of ID26:2004/(R)2009 an AAMI guidance document Major and technical is variations IEC :2001 intended to allow potential ANSI/AAMI purchasers EC38:2007 to evaluate the content Major technical of the variations IEC :2009 ANSI/AAMI/IEC :2009 Identical IEC :2010 document ANSI/AAMI/IEC before making :2010 a purchasing decision. Identical IEC :2009 and Technical ANSI/AAMI/IEC :2009 and Identical (with inclusion) Corrigendum 1 ANSI/AAMI/IEC :2009/ C1:2009 C1 Identical to Corrigendum 1 For a complete (amdt) consolidated copy of this text AAMI document, IEC :2008 contact ANSI/AAMI/IEC AAMI at :2008 (877) Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006 ANSI/AAMI/IEC TIR62348:2006 Identical IEC/TR 62354:2009 ANSI/AAMI/IEC TIR62354:2009 Identical IEC 62366:2007 ANSI/AAMI/IEC 62366:2007 Identical IEC/TR :2009 ANSI/IEC/TR :2009 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005/(R)2010 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 Identical ISO 8637:2010 ANSI/AAMI/ISO 8637:2010 Identical ISO 8638:2010 ANSI/AAMI/ISO 8638:2010 Identical ISO :2009 ANSI/AAMI/ISO :2009 Identical ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO :2003 ANSI/AAMI/ISO :2003/(R)2009 Identical ISO :2002 and ANSI/AAMI/ISO :2002/(R)2009 and Identical Amendment 1:2006 Amendment 1:2006/(R)2009 ISO :2009 ANSI/AAMI/ISO :2009 Identical ISO :2007 ANSI/AAMI/ISO :2007/(R)2010 Identical ISO :2008 ANSI/AAMI/ISO :2008 Identical ISO :2009 ANSI/AAMI/ISO :2009 Identical ISO :2010 ANSI/AAMI/ISO :2010 Identical ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2010 ANSI/AAMI/ISO :2010 Identical ISO :2001 ANSI/AAMI/ISO :2001/(R)2006 Identical ISO :2000 ANSI/AAMI/ISO :2000/(R)2006 Identical ISO :2010 ANSI/AAMI/ISO :2010 Identical ISO :2002 ANSI/AAMI/ISO :2002/(R)2008 Identical ISO :2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS :2006 ANSI/AAMI/ISO TIR :2006 Identical ISO/TS :2006 ANSI/AAMI/ISO TIR :2006 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO/TS :2008 ANSI/AAMI/ISO TIR :2008 Identical ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 v

8 International designation U.S. designation Equivalency ISO :2006 ( ANSI/AAMI/ISO :2006 Identical corrected version) ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO : 2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO : 2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO : 2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO : 2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO : 2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO :2005 ANSI/AAMI/ISO :2005/(R)2010 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO :2006 ANSI/AAMI/ISO :2006/(R)2010 Identical ISO 11663:2009 ANSI/AAMI/ISO 11633:2009 Identical ISO : 2006 ANSI/AAMI/ISO :2006 Identical ISO :2009 ANSI/AAMI/ISO :2009 Identical ISO/TS 12417:2011 ANSI/AAMI/ISO TIR12417:2011 Identical ISO :2008 ANSI/AAMI/ISO PREVIEW :2008 COPY Identical ISO :2003 ANSI/AAMI/ISO :2003 Identical ISO :2006 ANSI/AAMI/ISO :2006 Identical ISO :2005 ANSI/AAMI/ISO :2005 Identical ISO :2006 ANSI/AAMI/ISO :2006 Identical ISO :2006 intended to allow potential ANSI/AAMI/ISO purchasers :2006 to evaluate the content Identical of the ISO 13485:2003 document ANSI/AAMI/ISO before making 13485:2003/(R)2009 a purchasing decision. Identical ISO 13958:2009 ANSI/AAMI/ISO 13958:2009 Identical ISO 13959:2009 ANSI/AAMI/ISO 13959:2009 Identical ISO 14155:2011 For a complete ANSI/AAMI/ISO copy 14155:2011 of this AAMI document, Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998/(R)2008 Identical ISO 14161:2009 contact ANSI/AAMI/ISO AAMI at 14161:2009 (877) Identical ISO :2008 ANSI/AAMI/ISO :2008 Identical ISO :2008 ANSI/AAMI/ISO :2008 Identical ISO :2010 ANSI/AAMI /ISO :2010 Identical ISO 14937:2009 ANSI/AAMI/ISO 14937:2009 Identical ISO/TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2007 ANSI/AAMI/ISO 14971:2007/(R)2010 Identical ISO :2007 and A1:2008 ANSI/AAMI/ISO :2007 and A1:2008 Identical ISO :2010 ANSI/AAMI/ISO :2010 Identical ISO 15225:2010 ANSI/AAMI/ISO 15225:2010 Identical ISO 15674:2009 ANSI/AAMI/ISO 15674:2009 Identical ISO 15675:2009 ANSI/AAMI/ISO 15675:2009 Identical ISO 15882:2008 ANSI/AAMI/ISO 15882:2008 Identical ISO :2006 ANSI/AAMI ST :2009 Major technical variations ISO/TR 16142:2006 ANSI/AAMI/ISO TIR16142:2005 Identical ISO 17664:2004 ANSI/AAMI ST81:2004 Major technical variations ISO :2006 ANSI/AAMI/ISO :2006 Identical (with inclusions) ISO/TS :2009 ANSI/AAMI/ISO TIR :2009 Identical ISO 18472:2006 ANSI/AAMI/ISO 18472:2006/(R)2010 Identical ISO/TS 19218:2005 ANSI/AAMI/ISO 19218:2005 Identical ISO 20857:2010 ANSI/AAMI/ISO 20857:2010 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO 23500:2011 ANSI/AAMI/ISO 23500:2011 Identical ISO :2003 and A1:2005 ANSI/AAMI/ISO :2003/(R)2009 and Identical A1:2005/(R)2009 ISO :2008 ANSI/AAMI/ISO :2008 Identical ISO 26722:2009 ANSI/AAMI/ISO 26722:2009 Identical ISO 27186:2010 ANSI/AAMI/ISO 27186:2010 Identical ISO :2010 ANSI/AAMI/ISO :2010 Identical ISO :2007 ANSI/AAMI/ISO :2007 Identical ISO :2009 ANSI/AAMI/ISO :2009 Identical vi 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010

9 Committee representation Association for the Advancement of Medical Instrumentation Sterilization Standards Committee This standard was developed by the AAMI Dry Heat Sterilization Working Group under the auspices of the AAMI Sterilization Standards Committee. Committee approval of this standard does not necessarily imply that all committee and working group members voted for its approval. At the time this document was published, the AAMI Sterilization Standards Committee had the following members: Cochairs Members Alternates Victoria Hitchins PhD Michael Scholla Christopher Anderson, Boston Scientific Corporation Trabue D. Bryans, WuXi AppTec, Inc. Peter A. Burke, PhD, Steris Corporation Nancy Chobin, RN PREVIEW CSPDM, Independent COPY Expert Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology Kimbrell Darnell, CR Bard Dave Dion, Cardinal Health (MP&S) Lisa document Foster, Sterigenics before International making a purchasing decision. Joel R. Gorski, PhD, NAMSA Deborah A. Havlik, Hospira Worldwide Inc. Victoria For M. Hitchins, a complete PhD, FDA/CDRH copy of this AAMI document, Susan G. Klacik, contact CCSMC AAMI FCS ACE, at (877) IAHCSMM Byron J. Lambert, PhD, Abbott Laboratories Colleen Patricia Landers, or visit RN, Canadian Standards Association Lisa N. Macdonald, Becton Dickinson & Company Jeff Martin, Alcon Laboratories Inc. Patrick J. McCormick, PhD, Bausch & Lomb Inc. Rainer Newman, Johnson & Johnson Janet M. Prust, 3M Healthcare Nancy Rakiewicz, Ethox International Inc. Michael H. Scholla, Dupont Protection Technologies Mark Seybold, Baxter Healthcare Corporation Andrew Sharavara, PhD, Propper Manufacturing Co Inc. Mark N. Smith, Getinge USA William N. Thompson, Covidien Martell Kress Winters, BS SM, Nelson Laboratories Inc. William E. Young, Independent Expert Lloyd Brown, Covidien Glenn W. Calvert, Becton Dickinson & Company Steven J. Elliott, WuXi AppTec, Inc. Thomas J. Frazar, Johnson & Johnson Kathy Hoffman, Sterigenics International Jim Kaiser, Bausch & Lomb Inc. Natalie Lind, IAHCSMM Reynaldo Lopez, Cardinal Health (MP&S) Ralph Makinen, Boston Scientific Corporation Mary S. Mayo, CR Bard David Ford McGoldrick, BS, Abbott Laboratories James B. Neher, MS RAC, NAMSA Jerry R. Nelson, PhD, Nelson Laboratories Inc. Karen Polkinghorne, Dupont Protection Technologies Wallace E. Puckett, PhD, Steris Corporation Mike Sadowski, Baxter Healthcare Corporation Jason Voisinet, MOOG Medical Devices 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 vii

10 Craig A. Wallace, 3M Healthcare Valerie Welter, Hospira Worldwide Inc. NOTE Participation by federal agency representatives in the development of this technical information report does not constitute endorsement by the federal government or any of its agencies. At the time this document was published, the AAMI Dry Heat Sterilization Working Group had the following members: Cochairs Members Alternates Deborah A. Havlik Jeff Martin Carl W. Bruch, PhD, Independent Expert Marc Chaunet, TSO3 Inc. Nancy Chobin, RN CSPDM, Independent Expert Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses Jeff Crane, CPAC Equipment Inc. Douglas D. Davie, Sterilization Validation Services Anthony J. DeMarinis, PREVIEW BS MS CQA CQM, COPY CR Bard David Dominguez, CareFusion Betty D. Edge, Independent Expert Charles Oren Hancock, RAC, H&W Technology LLC Deborah A. Havlik, Hospira Worldwide Inc. Nyla Skee Japp, PhD RN CSPDM, Independent Expert Susan document G. Klacik, CCSMC before FCS making ACE, IAHCSMM a purchasing decision. Teckla A. Maresca, LPN CSPDM, Independent Expert Jeff Martin, Alcon Laboratories Inc. Elaine For S. Mayhall, a complete PhD, FDA/CDRH copy of this AAMI document, Gerald E. McDonnell, contact PhD, AAMI Steris at Corporation (877) Gary Mitchel, PE, Johnson or visit & Johnson Gerry A. O'Dell, MS, Gerry O'Dell Consulting Jason Pope, Nelson Laboratories Inc. Janet M. Prust, 3M Healthcare Frank Sizemore, Independent Expert Linda Slone, RN BSPA CNOR, Independent Expert Gary J. Socola, SPS Medical Supply Corp Ralph Stick, WuXi AppTec, Inc. Christian Supina, Baxter Healthcare Corporation James Whitcomb, LexaMed Ltd Nora E. Wikander, RN,CSPDM, Independent Expert Dennis L. Wildes, St Jude Medical Inc. Peter A. Burke, PhD, Steris Corporation Kimbrell Darnell, CR Bard Joseph R. Durbin, Hospira Worldwide Inc. Steven J. Elliott, WuXi AppTec, Inc. Dan B. Floyd, Nelson Laboratories Inc. Joe Gambino, CPAC Equipment Inc. Naomi Gamm, St Jude Medical Inc. Danny Hutson, CareFusion Daniel S. Larrimore, Alcon Laboratories Inc. Suzanne Leung, 3M Healthcare Natalie Lind, IAHCSMM Sheila A. Murphey, FDA/CDRH Cesar Perez, FDA/CDRH Robert Reich, LexaMed Ltd Mark Seybold, Baxter Healthcare Corporation Donald Tumminelli, SPS Medical Supply Corp NOTE Participation by federal agency representatives in the development of this technical information report does not constitute endorsement by the federal government or any of its agencies. viii 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010

11 Background of ANSI/AAMI adoption of ISO 20857:2010 As indicated in the foreword to the main body of this document (page x), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that took an active role in the development of this standard. ISO 20857:2010 was developed by ISO Technical Committee (TC) 198, Sterilization of health care products, and ISO/TC 198/WG 14, Dry heat. U.S. participation in ISO/TC 198 and ISO/TC 198/WG 14 is organized through the U.S. Technical Advisory Group (TAG) for ISO/TC 198, administered by the Association for the Advancement of Medical Instrumentation (AAMI) on behal f of the American National Standards Institute (ANSI). U.S. experts made a considerable contribution to this standard. The need for a standard on dry heat sterilization of medical devices was recognized by AAMI more than 10 years ago and resulted in the publication of ANSI/AAMI/ST63:2002. At that time, there was no I nternational Standard that addressed dry heat sterilization processes and the AAMI Dry Heat Sterilization Working Group patterned the new standard on an International Standard that addressed the development, validation and routine control of new or novel sterilization processes (adopted by AAMI as ANSI/AAMI/ISO 14937:2000). The U.S. TAG for ISO/TC 198 l ater proposed that ISO/TC 198 develop an International PREVIEW Standard on COPY dry heat sterilization and offered the AAMI standard as a first working draft. AAMI encourages its committees to harmonize their work with international standards as much as possible. Upon review of ISO 20857, the AAMI Sterilization Standards Committee and the AAMI Dry Heat sterilization Working Group decided to adopt intended ISO to verbatim, allow potential as a revision purchasers of ANSI/AAMI/ST63:2002, to evaluate Sterilization the content of health of the care products Requirements for the development, document validation, before and making routine a control purchasing of an industrial decision. sterilization process for medical devices Dry heat. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO documents. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI, which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. The concepts incorporated into this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data comes to light. As used within the context of this document, shall indicates requirements strictly to be followed to conform to the standard. Should indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited. May is used to indicate that a c ourse of action is permissible within the limits of the recommended practice. Can is used as a statement of possibility and capability. Finally, must is used only to describe unavoidable situations, including those mandated by government regulation. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA NOTE Beginning with the ISO foreword on page x, this American National Standard is identical to ISO 20857: Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 ix

12 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 ISO technical committees. Each member body interested in a s ubject for which a t echnical 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 collaborates 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. 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 document may be the subject of patent rights. ISO shall not document be held responsible before making for identifying a purchasing any or all decision. such patent rights. ISO was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. x 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010

13 Introduction A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for development, validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on t hem, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally PREVIEW best be described COPY by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of intended microorganisms to allow and potential b y the environment purchasers in to which evaluate the organisms the content exist during of the treatment. It follows that the sterility of document any one product before in making a population a purchasing subjected to decision. sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a product. This International Standard describes requirements that, if met, will provide a dr y heat sterilization process capable of sterilizing medical devices or visit through appropriate microbicidal activity. This International Standard also describes requirements that, if met, will provide a dry heat depyrogenation process through an appropriate denaturation activity. Furthermore, such compliance permits prediction, with reasonable confidence, that there is a low probability of there being a viable microorganism present on the product after processing. Specification of this probability is a matter for regulatory authorities and may vary from country to country (see for example EN and A NSI/AAMI ST67). Additionally, there will be a l ow probability of pyrogenic material of bacterial origin being present on the product after the application of a depyrogenation process. Generic requirements of the quality management systems for design/development, production, installation and servicing are given in ISO 9001 and par ticular requirements for quality management systems for medical device production in ISO The standards for quality management systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization and depyrogenation are examples of such processes. For this reason, sterilization and depyrogenation processes are validated for use, the performance of the processes is monitored routinely, and the equipment is maintained. Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use. Attention is therefore given to a number of factors including: a) the microbiological status of incoming raw materials and/or components; b) the validation and routine control of any cleaning and disinfection procedures used on the product; c) the control of the environment in which the product is manufactured, assembled and packaged; d) the control of equipment and processes; 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 xi

14 e) the control of personnel and their hygiene; f) the manner and materials in which the product is packaged; g) the conditions under which product is stored. These factors also need consideration for the provision of reliable assurance of depyrogenation. The type of contamination on the product to be sterilized varies and this variation influences the effectiveness of a sterilization and depyrogenation process. Product that has been used in a health care setting and is being presented for resterilization in accordance with the manufacturer's instructions (see ISO 17664) should be regarded as a special case. There is potential for such product to possess a wide range of contaminating microorganisms and r esidual inorganic and/or organic contamination in spite of the application of a c leaning process. Hence, particular attention has to be given to the validation and control of the cleaning and disinfection processes used during reprocessing. The requirements are the normative parts of this International Standard with which compliance is claimed. The guidance given in the informative PREVIEW annexes is not normative COPY and is not provided as a check list for auditors. The guidance provides explanations as well as methods that are accepted as being suitable means for complying with the requirements. Approaches other than those given in the guidance may be used if they are This effective is a in preview achieving edition compliance of an with AAMI the requirements guidance document of this International and is Standard. document before making a purchasing decision. The development, validation and routine control of a sterilization process and/or a depyrogenation process comprise a number of discrete but interrelated activities, for example calibration, maintenance, product definition, process For definition, a complete installation copy qualification, of this AAMI operational document, qualification and performance qualification. While the activities required by this International Standard have been grouped together and are presented in a p articular order, contact this AAMI International at (877) Standard does not require that the activities be performed in the order that they are presented. The activities required are not necessarily sequential, as the programs of development and v alidation might be i terative. It is possible that performing these different activities will involve a number of separate individuals and/or organizations, each of whom undertake one or more of these activities. This International Standard does not specify the particular individuals or organizations to carry out the activities. xii 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010

15 American National Standard ANSI/AAMI/ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices 1 Scope 1.1 Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance contact in relation AAMI to at depyrogenation (877) processes using dry heat. NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation. 1.2 Exclusions document before making a purchasing decision This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE See also ISO , ISO and ISO This International Standard does not apply to processes that use infrared or microwaves as the heating technique This International Standard does not detail a specified requirement for designating a medical device as "sterile." NOTE Attention is drawn to national or regional requirements for designating medical devices as sterile. See, for example, EN or ANSI/AAMI ST This International Standard does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a r equirement of this International Standard to have a c omplete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010 1

16 sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities. NOTE Requirements for operational safety are specified in IEC Additionally, safety regulations exist in some countries. document before making a purchasing decision Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 20857:2010