1、ANSI/AAMI/ISO 13408-1: 2008/(R)2017 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
2、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 ensu
3、re 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 t
4、hough 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 guidelin
5、es 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
6、 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
7、 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 indu
8、strial 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 p
9、ractice 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
10、-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
11、 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 p
12、ractices. 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 pa
13、rticular 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
14、 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 o
15、nly when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in wr
16、iting, 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 Associatio
17、n 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 pra
18、ctice 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. American National Standard ANSI/AAMI/ISO 13408-1:2008/(R)2017 Aseptic processing of health care products Part 1: Ge
19、neral requirements Approved 23 September 2008 by AAMIApproved 29 October 2008 and reaffirmed 14 December 2011 and 18 May 2017 by American National Standards Institute, Inc. Abstract: Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, v
20、alidation and routine control of the manufacturing process for aseptically processed health care products. Keywords: processes, validation, routine control, aseptic, guidanceAAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those sub
21、stantially 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 s
22、tandards 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 five years from the da
23、te 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 wit
24、hin 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. Published by
25、AAMI4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633 www.aami.org 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publication may be reproduced or distributed in any fo
26、rm, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. 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 externa
27、lly) 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, contact AAMI, 4
28、301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 978-1-57020-326-8Contents PageGlossary of equivalent standards v Committee representation. vii Background ANSI/AAMI adoption of ISO 13408-1:2008 ix Fore
29、word. x Introduction . xi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Quality system elements 7 4.1 General. 7 4.2 Assignment of responsibilities 8 4.3 Calibration . 8 5 Aseptic process definition . 8 5.1 General. 8 5.2 Risk management . 9 6 Manufacturing environment. 11 6.1 Ge
30、neral. 11 6.2 Manufacturing environment design 12 6.3 Layout. 13 6.4 Material and personnel flow. 15 6.5 HVAC system. 16 6.6 Cleanroom qualification . 18 6.7 Utility services and ancillary equipment 18 6.8 Environmental and personnel monitoring programs 19 7 Equipment 23 7.1 Qualification 23 7.2 Mai
31、ntenance of equipment. 25 8 Personnel. 26 8.1 General. 26 8.2 Training for APA qualification . 26 8.3 Gowning procedures 28 8.4 General employee health . 29 9 Manufacture of the product . 29 9.1 Attainment and maintenance of sterility. 29 9.2 Duration of the manufacturing process 30 9.3 Aseptic manu
32、facturing procedures 31 9.4 Cleaning and disinfection of facilities 31 9.5 Cleaning, disinfection and sterilization of equipment 33 10 Process simulation . 35 10.1 General. 35 10.2 Media selection and growth support 35 10.3 Simulation procedures . 35 10.4 Incubation and inspection of media filled un
33、its 36 10.5 Initial performance qualification 37 10.6 Periodic performance requalification . 38 10.7 Repeat of initial performance qualification 38 10.8 Documentation of process simulations38 10.9 Disposition of filled product 39 11 Test for sterility . 40 11.1 General. 40 11.2 Investigation of posi
34、tive units from tests for sterility. 41 Annex A (informative) Example of a flow chart . 42 Annex B (informative) Typical elements of an aseptic process definition. 43 Annex C (informative) Examples of specific risks 44 Annex D (informative) Comparison of classification of cleanrooms 45 Annex E (info
35、rmative) Specification for water used in the process 46 Annex F (informative) Aseptic processing area 48 Bibliography . 49 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-1:2008 v Glossary of equivalent standards International Standards adopted in the United State
36、s 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
37、designation. 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 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variation
38、s IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 IdenticalIEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 IdenticalIEC 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/AA
39、MI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 6060
40、1-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 IdenticalIEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 IdenticalIEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/I
41、EC TIR62348:2006 IdenticalISO 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 IdenticalISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical
42、 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 Iden
43、tical 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 IdenticalISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technical variat
44、ions 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
45、/(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/
46、AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical International designation U.S. designation Equivalency ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected ver
47、sion)ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/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:
48、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 11140-5:200
49、7 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical ISO 13408-2:2003 ANSI/AAMI/ISO 13408-2:2003 Identical ISO 13408-3:2006 ANSI/AAMI/ISO 13408-3:2006 Identical ISO 13408-4:2005 ANSI/AAMI/ISO 13408-4:2005 Identical ISO 13408-5:2006 ANSI/AAMI/ISO 13408-5:2006 Identical ISO 13408-6:2006 ANSI/AAMI/ISO 13408-6:2006 Identical ISO 13485:2
