ISO 13408- 01_preview

ANSI/AAMI/ISO 13408-1:2008PREVIEW COPY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. Aseptic processing of health care products — Part 1: General requirements For a complete copy of this AAMI document, contact AAMI at (877) 249-8226 or visit www.aami.org. Association for the Advancement of Medical Instrumentation several important concepts must be recognized: of Medical Instrumentation disclaims responsibility for any All AAMI standards and recommended practices are voluntary characterization or explanation of a standard or recommended (unless. and the user must carefully review the reasons why the document was measurement techniques that can be used to determine whether the initially PREVIEW COPYdeveloped and the specific rationale for each of its device conforms with the safety and performance criteria and/or to provisions. The interpretation will become official and representation of professionals in understanding industrial practices. contact of 249-8226 performance characteristics often necessitates the development of www. A voluntary standard for a medical device recommends to the Despite periodic review and revision (at least once every five manufacturer the information that should be provided with or on years). even though a recommended practice is usually oriented towards healthcare professionals. specific needs and resources of the individual institution or firm. Similarly.Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an Each AAMI standard or recommended practice reflects the AAMI product standard or recommended practice are clearly collective expertise of a committee of health care professionals and understood. The Association for the Advancement document. Requests for interpretations of AAMI standards and recommended while not addressing device performance criteria. but rather recommended practice is an excellent guide to the reasoning and procedures and practices that will help ensure that a device is used data underlying its provision. a standard or recommended practice is necessarily a static the product. the consensus medical instrumentation. recommended practice should be analyzed in the context of the A recommended practice provides guidelines for the use.aami. A voluntary standard can of committee work. a for establishing the criteria must be documented in the rationale. care. This a different products. instructions to existing decision. basic safety and performance criteria that should be document applied to a dynamic technology. clinical environment. but the ultimate decision as to product clinical concerns warrant the establishment of minimum safety and safety and efficacy must take into account the specifics of its performance criteria. . cost-benefit considerations. and (2) the encouragement of new ensure patient safety. experience and judgment. professional judgment must be used in applying these criteria to or visit specialized test methods to facilitate uniformity in reporting. a standard or recommended practice is truly Although a device standard is primarily directed to the useful only when it is used in conjunction with other sources of manufacturer. An official interpretation must be processing. document before making a purchasing devices and equipment. in the sense that it responds generally to practices can contribute significantly to the advancement of perceived risks and conditions that may not always be relevant to medical instrumentation. The objectives of AAMI's technical development industrial representatives. A standard or recommended practice is an attention to these objectives and provided that arbitrary and important reference in responsible decision-making. it may be useful to the INTERPRETATIONS OF AAMI STANDARDS manufacturer in better understanding the environment in which a AND RECOMMENDED PRACTICES medical device will be used. warnings and precautions. As such. it may also be of value to the potential purchaser or information and policy guidance and in the context of professional user of the device as a frame of reference for device evaluation. of course. Also. provided that they are drafted with specific situations. whose work has been reviewed program derive from AAMI's overall mission: the advancement of nationally (and sometimes internationally). Similarly. This review will reveal whether the document remains compare the performance characteristics isof preview edition of an AAMIrelevant to the specific and isof the user. and other processing or evaluation subsequently reviewed and approved by the AAMI Standards techniques. safely and effectively and that its performance will be maintained. existing equipment. A recommended Again. When a drafting committee determines that be used as one resource. including performance characteristics. such guidelines may be useful to health care Board. and other data considered practice to current procedures and practices. some recommended practices. Therefore. by recommended practice is solely within the discretion and appropriate notice. the Association only upon exhaustion of any appeals and upon In determining whether an AAMI standard or recommended publication of notice of interpretation in the "Standards Monitor" practice is relevant to the specific needs of a potential user of the section of the AAMI News. professional judgment of the user of the document. guidance document needs Some standards emphasize the information that allow potential purchasers to evaluate the content ofbe taken in applying a product standard Particular care should the intended to should be provided with the device. The application of a standard or accordance with this procedure and which is not published. however. as an official interpretation in the AAMI News. ultimately. referee tests must be provided and the reasons utilization and. While observed or important in ensuring the safe and effective use For a completethe of thispotential risks with existing equipment typically form the basis for of the device in copy AAMI document. methods of collecting data to establish safety and approved by letter ballot of the originating committee and efficacy. the rationale accompanying each AAMI standard and practice does not address device performance per se. but it should never replace responsible decision-making.org. they are adopted by government regulatory or practice which has not been developed and communicated in procurement authorities). It is AAMI's view that standards and recommended limited. No single source of information will serve to reaching consensus on these tests can represent a considerable part identify a particular product as "unsafe". human engineering. and/or processing of a medical device or system. to help continued increase in the safe and effective application of current technologies to patient care. to the AAMI Vice President. restrictive uses are avoided. Essential to such advancement are (1) a recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and. a standards considered in qualifying the device for clinical use. A standard or recommended practice is technologies. guidelines to industrial personnel on such subjects as sterilization Standards Policy and Programs. In summary. provide practices must be made in writing. Recommending the disclosure AAMI at (877)the safety and performance criteria defined in a standard. and in applying a recommended for use. of course. aami.org. validation. Abstract: Specifies the general requirements for. guidance Keywords: . and offers guidance on. processes. Inc. processes. aseptic.American National Standard ANSI/AAMI/ISO 13408-1:2008 PREVIEW COPY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. Aseptic processing of health care products — Part 1: General requirements Approved 23 September 2008 by Association for the Advancement of Medical Instrumentation Approved 29 October 2008 by American National Standards Institute. contact AAMI at (877) 249-8226 or visit www. routine control. validation and routine control of the manufacturing process for aseptically processed health care products. programs and procedures for development. For a complete copy of this AAMI document. in which case the adopting agency is responsible for enforcement of its rules and regulations.org © 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO. revise. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. Arlington. This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. Glebe Road. or withdraw this standard no later than five years from the date of publication. 1110 N. or using products.AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions.aami. Fax: (703) 525-1067.S. marketing. VA 22201-4795 www. For a complete copy of this AAMI document.aami. whether they have approved the standard or not. including civil and criminal penalties.org. contact AAMI. ANSI. from manufacturing. et seq. or procedures not conforming to the standard. For permission regarding the use of all or any part of this document. purchasing. Phone: (703) 525-4890. and their application is solely within the discretion and professional judgment of the user of the document. and users are cautioned to obtain the latest editions. and AAMI. Suite 220. Violators risk legal action. No part of this publication may be reproduced or distributed in any form.) 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.C. All AAMI standards. All requests pertaining to this document should be submitted to AAMI. processes. without the prior written permission of AAMI. Suite 220 Arlington. Published by Association for the Advancement of Medical Instrumentation 1110 N. contact AAMI at (877) 249-8226 or visit www. technical information reports. § 101. recommended practices. The existence of an AAMI standard does not in any respect preclude anyone. Glebe Road. including an electronic retrieval system. and damages of $100. and other types of technical documents developed by AAMI are voluntary. voluntary technical documents are adopted by government PREVIEW COPY regulatory agencies or procurement authorities. VA 22201-4795. It is illegal under federal law (17 U. AAMI standards are subject to periodic review. Occasionally. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. Printed in the United States of America ISBN 1–57020–326–1 .000 per offense. AAMI procedures require that action be taken to reaffirm. ...................................................5 6......................................................................................................................................................................... 23 Maintenance of equipment....................................................................... 11 Manufacturing environment design . 33 Process simulation ................................................................................................................................ 29 Duration of the manufacturing process................................................................. xi 1 2 3 4 4........................................................... contact AAMI at (877) 249-8226 General....2 8 8..................................................................................... 26 Gowning procedures .......2 8................................................................................. 23 Qualification ..................................................................................................... 31 Cleaning.............................................................. 31 Cleaning and disinfection of facilities ...........................4 9.... Risk management ...................................................... 26 Training for APA qualification .........................................................................................................1 9................................................................................................................... 2 PREVIEW COPY Quality system elements.......................................................................................................................................................Contents Page Glossary of equivalent standards .............................4 9 9..............................................1 Scope............................1 4.......... 29 Attainment and maintenance of sterility........... vii Background ANSI/AAMI adoption of ISO 13408-1:2008.................................................................................................................................................................................5 10 10..7 6............................................................................................................................. x Introduction ........................................................................................................................ 1 Terms and definitions....................................................................................... 1 Normative references ..................................2 9.. 28 General employee health ...............1 5................................................................ v Committee representation................................... 7 intended to allow potential purchasers to evaluate the content of the Assignment of responsibilities................................................................................................................................................................................................................................................... 15 HVAC system............................................................................................................................................ 8 or visit www. 29 Manufacture of the product .1 7......... 8 document before making a purchasing decision................. 8 Aseptic process definition a complete copy of this AAMI document..........................2 6.......................................................1 6. 9 Manufacturing environment.............................................................................................................. 7 This is a preview edition of an AAMI guidance document and is General................................................................................................ 25 Personnel.........org..............................................................................................3 9.............................................................................................................................3 5 5..........................................................................aami................................................................................................................................................... 11 General............................ 35 General...................................................... 16 Cleanroom qualification ....................................1 8........................................................................................................................4 6..........................................................................................2 6 6............................... 18 Utility services and ancillary equipment ...................................................... 19 Equipment....................................................... 26 General................................ 12 Layout................................................................... disinfection and sterilization of equipment ...........................................................................................................................................................................................................................................................................................................................6 6.........................................................3 8................. 35 ....... Calibration ....................................................................................................................................... 30 Aseptic manufacturing procedures .................................................................................................... 8 For ..........................2 4..........3 6................................................................................................................................................... ix Foreword ..................8 7 7........................................................... 13 Material and personnel flow................................................................................................. 18 Environmental and personnel monitoring programs... ......................................................................................................................................2 Media selection and growth support ........................................... 38 Documentation of process simulations..................................7 10........................... 45 Annex E (informative) Specification forPREVIEW COPY water used in the process............................................................................................................... 43 Annex C (informative) Examples of specific risks ................. 48 This is a preview edition of an AAMI guidance document and is document before making a purchasing decision............. 36 Initial performance qualification......... 40 General.....1 11.............................................................................................................................................................4 10..................................................... 40 Investigation of positive units from tests for sterility ...................................................... 44 Annex D (informative) Comparison of classification of cleanrooms .................................................................. For a complete copy of this AAMI document................................................................................................................................................................................................................................5 10........................ 39 Test for sterility ............................................................... 49 intended to allow potential purchasers to evaluate the content of the .......................................................................................... contact AAMI at (877) 249-8226 or visit www........................................6 10.....................................................................................................................................org......... 35 Incubation and inspection of media filled units ..................................................... 35 Simulation procedures ...................................................................................9 11 11.................................................................... 41 Annex A (informative) Example of a flow chart ............................. 42 Annex B (informative) Typical elements of an aseptic process definition ....... 38 Disposition of filled product .........................................3 10..............2 10......................................10.... Bibliography .... 37 Periodic performance requalification ...............................8 10.......aami............................... 38 Repeat of initial performance qualification ......... 46 Annex F (informative) Aseptic processing area ..... therefore. this list should not be considered exhaustive. the table below gives the corresponding U. Identical contact AAMI at (877) 249-8226 IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical or visit www. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and A1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and A1:1996 ANSI/AAMI II51:2004 Major technical variations Identical IEC 60601-2-21:1994 and ANSI/AAMI/IEC 60601-2-21 and Amendment 1:1996 Amendment 1:2000 (consolidated texts) PREVIEW COPY IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations This is a preview edition of an AAMI guidance document and is IEC 60601-2-50:2001 intended to allow potential purchasers to evaluate the content of the ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical document before making a purchasing decision. IEC/TR 62348:2006 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and A1:2006 ANSI/AAMI/ISO 10993-4:2002 and A1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical Minor technical variations ISO 10993-10:2002 and Amendment ANSI/AAMI BE78:2002/(R)2008 1:2006 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002/(R)2008 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 v .org. adoption by AAMI. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U. IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical For a complete copy TIR62296:2003 IEC/TR 62296:2003 ANSI/AAMI/IEC of this AAMI document.S.S. designation and level of equivalency to the International Standard. International designation U.Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards.aami.S. For each International Standard that has been adopted by AAMI (and ANSI). ISO 13408-6:2006 ANSI/AAMI/ISO 13408-6:2006 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003/(R)2008 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003/(R)2008 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998/(R)2008 Identical ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical ISO/TR 14969:2004 ISO 14971:2007 ISO 15223-1:2007 and A1:2008 ISO 15225:2000 and A1:2004 ISO 15674:2001 ISO 15675:2001 ISO 15882:2008 ISO/TR 16142:2006 ISO 17664:2004 ISO 17665-1:2006 ISO 18472:2006 ISO/TS 19218:2005 ISO 22442-1:2007 ISO 22442-2:2007 ISO 22442-3:2007 ISO 25539-1:2003 and A1:2005 ISO 25539-2:2008 ISO 81060-1:2007 ANSI/AAMI/ISO TIR14969:2004 ANSI/AAMI/ISO 14971:2007 ANSI/AAMI/ISO 15223-1:2007 and A1:2008 ANSI/AAMI/ISO 15225:2000/(R)2006 and A1:2004/(R)2006 ANSI/AAMI/ISO 15674:2001 ANSI/AAMI/ISO 15675:2001 ANSI/AAMI/ISO 15882:2008 ANSI/AAMI/ISO TIR16142:2005 ANSI/AAMI ST81:2004 ANSI/AAMI/ISO 17665-1:2006 ANSI/AAMI/ISO 18472:2006 ANSI/AAMI/ISO 19218:2005 ANSI/AAMI/ISO 22442-1:2007 ANSI/AAMI/ISO 22442-2:2007 ANSI/AAMI/ISO 22442-3:2007 ANSI/AAMI/ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-2:2008 ANSI/AAMI/ISO 81060-1:2007 Identical Identical Identical Identical Identical Identical Identical Identical Major technical variations Identical Identical Identical Identical Identical Identical Identical Identical Identical vi © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 .org.aami. ISO 13408-2:2003 ANSI/AAMI/ISO 13408-2:2003 Identical ISO 13408-3:2006 ANSI/AAMI/ISO 13408-3:2006 Identical For a complete copy of this AAMI document. ISO 13408-4:2005 ANSI/AAMI/ISO 13408-4:2005 Identical contact AAMI at (877) 249-8226 ISO 13408-5:2006 ANSI/AAMI/ISO 13408-5:2006 Identical or visit www.S.International designation U. designation Equivalency ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006 ANSI/AAMI/ISO 11137-1:2006 Identical ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected version) ISO 11137-3:2006 ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-3:2007 ANSI/AAMI/ISO 11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006 ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006 ANSI/AAMI/ISO 11607-2:2006 Identical PREVIEW COPY ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO AAMI guidance Identical This is a preview edition of an 11737-2:1998 document and is intended to allow potential purchasers to evaluate the content of the ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical document before making a purchasing decision. S. St Jude Medical Inc. BS Alcon Laboratories Inc. Jr. intended to allow potential purchasers to evaluate the content of the Carol M. Reich. Rouse. Martell Kress Winters. BS MS. Osburn Department of Veterans Affairs National Center for Patient Safety Janet M. Prust. Tyrone S. Havlik. 3M Healthcare Robert R. Finocchario. Jr. Nelson Laboratories Inc. Bob L. Kimberly-Clark Corporation Mike Sadowski. PhD. 3M Healthcare Dennis L. LexaMed Carlos A. AAMI at (877) 249-8226 contact Rainer Newman. PhD. Zimmer Inc. Lampe. CR Bard PREVIEW COPY William Facemire. Johnson & Johnson or visit www. Zimmer Inc. Lasich. Catherine J. At the time this document was published. Lisa N. representatives from the AAMI Aseptic Processing Working Group (U. Cheryl Work. Bausch & Lomb Inc.document before making a purchasing decision. Sterilization Science Inc. Mills. Mayhall. Hospira Worldwide Inc. Morris.S.aami. Alcon Laboratories Inc. The AAMI Aseptic Processing Working Group also functions as a U. Frank Peacock. Bausch & Lomb Inc. Hospira Worldwide Inc. FDA/CDRH Kimbrell Darnell. Macdonald.guidance document and is This is a preview edition of an AAMI Brent Huberty. Becton Dickinson & Company Alternates: NOTE—Participation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. St Jude Medical Inc. FDA/CDRH Tonya M. Baxter Healthcare Corporation David Silor. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). Becton Dickinson &of this AAMI document. Arista Lisa N. Rodriguez-Garcia. Sub-TAG for ISO/TC 198/WG 9) played an active part in developing the ISO standard.. BS.org. Baxter Healthcare Corporation Joseph J.S.. Nelson Laboratories Inc. BS MS CQA CQM Alternate CR Bard Deborah A. BS SM. DeMarinis. Elaine S. © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 vii . the AAMI Aseptic Processing Working Group had the following members: Cochairs: Members: Thomas J. Wildes. U. Chris Marsh. Anthony J. For a complete copy Company Russell D. Wallace. Macdonald Thomas J. Johnson & Johnson Craig A. Cardinal Health (MP&S) Manuel Saavedra.Committee representation Association for the Advancement of Medical Instrumentation Aseptic Processing Working Group The adoption of ISO 13408-1:2008 as an American National Standard was initiated by the AAMI Aseptic Processing Working Group of the AAMI Sterilization Standards Committee. Kimberly-Clark Corporation Valerie Welter. Arista. Robert P Tomaselli. Phil M. Boston Scientific Corporation Mary S. Baxter Healthcare Corporation John R. Burke. PhD. Steris Corporation Nancy Chobin. NAMSA Deborah A. Thompson. Propper Manufacturing Co Inc. IAHCSMM Ralph Makinen. Canadian Standards Association David Liu. Boston Scientific Corporation Ramona Conner. PhD. Whitby. PhD. Chiu S. 3M Healthcare Mike Sadowski. Boston Scientific Corporation Alternates: NOTE—Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. Klacik. MB. Cardinal Health (MP&S) Lois Atkinson Jones. PhD. Peter A. Joseph J. Abbott Laboratories Jerry R.aami. IAHCSMM Byron J. Baxter Healthcare Corporation or visit www. Lin. Covidien James L. Mayo. the AAMI Sterilization Standards Committee had the following members: Cochairs: Members: Victoria M. RN CSPDM.. Lasich. Becton Dickinson & Company Jeff Martin. FRCP (Independent Expert) Martell Kress Winters.org. RN. Macdonald. Calvert. Schneider. William E. Karen Polkinghorne. PhD. Alcon Laboratories Inc. Dupont Nonwovens Janet M. intended to allow potential purchasers to evaluate the content of the Susie McDonald. Johnson & Johnson Kathy Hoffman. PhD. Abbott Laboratories Colleen Patricia Landers. Michael H. CR Bard Lisa Foster. Hitchins. Bausch & Lomb Inc. Nelson Laboratories Inc. Bausch & Lomb Inc. BS SM. Mark N. Young Trabue D. Johnson & Johnson PREVIEW COPY Lisa N. Sterigenics International Joel R. (Independent Expert) Susan G. Hospira Worldwide Inc. Valerie Welter. WuXi AppTec Inc. Sterigenics International Jim Kaiser. CR Bard David Ford McGoldrick. Havlik. American Society for Healthcare Central Service Professionals document before making a purchasing decision. Steris Corporation Ralph Stick. (Independent Expert) Charles Cogdill. MA. Nelson Laboratories Inc. FDA/CDRH Natalie Lind. Gorski. Jr.At the time this document was published. Becton Dickinson & Company Dave Dion. Bryans. Ethox International Inc. McCormick. Smith. PhD William E. Dupont Nonwovens contact AAMI at (877) 249-8226 Mark Seybold. RN MSN CNOR. MS. PhD. Andrew Sharavara. Prust. BS. Association of Perioperative Registered Nurses Jacqueline Daley. Victoria M. Scoville. CCSMC FCS ACE. Lloyd Brown. Jason Voisinet. This is a preview edition of an AAMI guidance document and is Patrick J. 3M Healthcare For a complete copy of this AAMI document. Getinge USA William N. BS. Frazar. Association for Professionals in Infection Control and Epidemiology Kimbrell Darnell. Scholla. viii © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 . Hitchins. Lambert. Ethox International Inc. Alcon Laboratories Inc. Nancy Rakiewicz. Young. WuXi AppTec Inc. Hospira Worldwide Inc. Covidien Glenn W. Cardinal Health (MP&S) Thomas J. FDA/CDRH Danny Hutson. Nelson. PhD. Glebe Road. The U. developments. the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. NOTE—Beginning with the ISO foreword on page x. Comments AAMI document. designation and the level of equivalency with the corresponding COPY ISO standard.S. Technical Advisory Group for ISO/TC 198. TAG for ISO/TC 198 supports the guidance provided in this document for aseptic processing of health care products.aami. AAMI.Background of ANSI/AAMI adoption of ISO 13408-1:2008 As indicated in the foreword to the main body of this document (page ix). or visit www. participation in this ISO TC is organized through the U. This is a preview edition of an AAMI guidance document and is The concepts incorporated in this standardpotentialnot be considered inflexible content of the standard. 1110 N. validation and routine control of the manufacturing process for aseptically processed health care products. For are invited. programs and procedures for development. revised every 5 years to reflect technological advances that may have occurred since publication. to fill a need for guidance regarding processes. U. like any other. Sterilization of health care products.org.S.S. which was developed by ISO Technical Committee 198. AAMI (and ANSI) have adopted other ISO standards.S. AAMI and ANSI procedures require that standards be reviewed and. administered by the Association for the Advancement of Medical Instrumentation (AAMI). document assimilate progressive technological it must be modified as technological advances are made and as new data come to light. The United States is one of the ISO members that took an active role in the development of this standard. The U.S. intended to allow should purchasers to evaluate the or static. adoption of ANSI/AAMI/ISO 13408-1:2008 was approved by the American National Standards Institute (ANSI) on 29 October 2008. Arlington. To remain relevant. VA 22201-4795. Suggestions for improving this standard a complete copy of this and suggested revisions should be sent to Standards contact AAMI at (877) 249-8226 Department. which gives thePREVIEW U. Suite 220. this American National Standard is identical to ISO 13408-1:2008 © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 ix . See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI. This must be reviewed and updated periodically tobefore making a purchasing decision. if necessary. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. which has been technically This is a preview edition of an AAMI guidance document and is revised. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives.13408-1:1998). also take part in the work. ISO 13408-1 was prepared by Technical Committeeof this AAMI document. ISO 13408 consists of the following parts. Publication as an PREVIEW COPY International Standard requires approval by at least 75 % of the member bodies casting a vote. Sterilization of health care products. The work of preparing International Standards is normally carried out through ISO technical committees.Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). governmental and non-governmental. The main task of technical committees is to prepare International Standards.org. Attention is drawn to the possibility that some of the elements of the content of themay be the subject of intended to allow potential purchasers to evaluate this document patent rights. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. under the general title Aseptic processing of health care products: ⎯ Part 1: General requirements ⎯ Part 2: Filtration ⎯ Part 3: Lyophilization ⎯ Part 4: Clean-in-place technologies ⎯ Part 5: Sterilization in place ⎯ Part 6: Isolator systems x © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 . For a complete copy ISO/TC 198. document before for identifying any decision. International organizations. in liaison with ISO. Part 2. contact AAMI at (877) 249-8226 or first edition (ISO This second edition cancels and replaces thevisit www. ISO shall not be held responsible making a purchasingor all such patent rights. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.aami. Any normative and informative clauses on subjects which have meanwhile been addressed in Part 2 to Part 6 of ISO 13408 have been removed from this part. Examples of applications in which aseptic processing are used include: ⎯ aseptic handling and filling of solutions. transfer and packaging of solid products including solid medical devices. For the control of of this AAMI document. Validated systems. Wherever possible. applicable to aseptic processing.aami. The product is processed in a controlled environment where microbial and particulate levels are maintained at defined minimal levels and where human intervention is minimized. adequately trained personnel. ⎯ aseptic handling. by moist heat (ISO 17665-1). tissues. For pharmaceuticals and medical devices there might be various requirements including compliance with ISO standards. semisolids and powders. Sterilization procedures which render components and/or parts sterile as a prerequisite for further aseptic processing can be treated as separate procedures. They have to be evaluated and validated separately and it is important that their risk of failure is minimal. © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 xi . transfer and packaging of combination products. ⎯ aseptic handling of tissues or biological production systems. this part of ISO 13408 is focused on the risks to the maintenance of sterility. Aseptic processing can also be used to prevent contamination of before making a purchasing decision. this is not or visit www. suspensions. The aseptic process definition encompasses all production steps following the sterilization of product and components until the final container or package is sealed. Aseptic processing intends to This is a preview edition of anthe pre-sterilized components and products during maintain the sterility of AAMI guidance document and is assembling. It is important to control all possible sources of contamination in order to maintain the sterility of each and every component. healthcare products intended to be sterile should be sterilized in their final sealed container (terminal sterilization). When a health care product is intended to be sterile and cannot be terminally sterilized. document biological product or biological systems (e. by dry heat (ISO 20857. aseptic processing provides an alternative. While terminal sterilization involves a complete copya well-defined process of known lethality delivered to the product and a sterility assurancecontact(SAL) at (877) 249-8226 level AAMI can be extrapolated from sterilization data. product parts and/or components and all PREVIEW COPY equipment coming into direct contact with the aseptically-processed product is required.org. To keep the aseptic process definition clear and workable. vaccines).Introduction Health care products that are labeled “sterile” are prepared using appropriate and validated methods under stringent control as part of a quality management system. ⎯ aseptic handling. To achieve this. controlled environments and welldocumented systematic processes are applied to assure a sterile finished product. in preparation) and by ethylene oxide (ISO 11135-1). a risk-based aseptic process definition is established encompassing each product and applied in a comprehensive way considering product. environment and manufacturing process designs. Presterilization of product. GMP regulations and pharmacopoeial requirements. The resulting product is required purchasers to evaluate the content of the intended to allow potential to be sterile in its final container. ISO/TC 198 has prepared standards for terminal sterilization of health care products by irradiation (series ISO 11137).g. package design. equipment and utilities such as water systems be considered and minimized. sterilization of product or components including sterile filtration. product. components. can the controls on the aseptic process be considered to be acceptable.The aseptic process is divided into unit operations (e.aami. Appropriate validation of the specified elements of the aseptic process is needed. of which process simulation studies are an essential. wherever possible minimized. contact AAMI at (877) 249-8226 or visit www. facility. PREVIEW COPY This is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. This revision of ISO 13408-1:1998 is intended to adopt this International Standard to the actual state of technology in the field. xii © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 . eliminated or controlled and finally have been evaluated as acceptable. personnel.org. Only if all risks of contamination have been recognized.g. handling and storage of sterilized product) and it is necessary that potential sources of contamination from materials. For a complete copy of this AAMI document. assembly of components. org.aami. clean-in place (CIP) technologies.guidance document and(SIP) and isolator systems intended to allow potential purchasers to evaluate the content of the are given in other parts of ISO 13408.American National Standard ANSI/AAMI/ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements 1 Scope 1. © 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 1 . lyophilization. validation and routine control of the manufacturing process for aseptically-processed health care products. such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional contact AAMI at (877) 249-8226 jurisdictions. PREVIEW COPY 1. before making a purchasing decision. For a complete copy of replace national regulatory requirements. Specific requirements and guidance on various specialized processes and methods related to This is a preview edition of an AAMI sterilization in place is filtration. or visit www. document NOTE This part of ISO 13408 does not supersede or this AAMI document. processes.1 This part of ISO 13408 specifies the general requirements for.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. programs and procedures for development. and offers guidance on.