1、ANSI/AAMI/ISO 13408-3: 2006/(R)2015Aseptic processing of health care products Part 3: LyophilizationAmerican National StandardObjectives 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 practic
2、e are clearly understood. The objectives of AAMIs technical development program derive from AAMIs 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
3、 (2) the encouragement of new technologies. It is AAMIs 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 avo
4、ided. 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
5、 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, warn
6、ings 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;
7、 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
8、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
9、 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 usu
10、ally 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
11、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 standa
12、rd 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 a
13、pplication 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
14、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
15、 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 an
16、d 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 provisio
17、ns. 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 potenti
18、al 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 vol
19、untary 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
20、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
21、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 writing, to the AAMI Vice President,
22、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 appea
23、ls 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
24、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 13408-3:2006/(R)2015 Aseptic processing of health care products Part 3: Lyophilization Approved 23 September
25、2008 by Association for the Advancement of Medical Instrumentation Approved 14 October 2008 and reaffirmed 30 November 2012 and 13 July 2015 by American National Standards Institute, Inc. Abstract: Specifies requirements for and offers guidance on equipment, processes, programs and procedures for th
26、e control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process. Keywords: lyophilization, aseptic processingAAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a cons
27、ensus 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 th
28、e 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 five
29、 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 applica
30、tion 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 regulati
31、ons. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., 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, ANSI, an
32、d AAMI. No part of this publication may be reproduced or distributed in any form, 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
33、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 per
34、mission regarding the use of all or any part of this document, contact AAMI, 4301 N. Fairfax Dr., Suite301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570203288 Contents PageGlossary of equivalent standards . iv Committee repre
35、sentation vi Background of ANSI/AAMI adoption of ISO 13408-3:2006 . viii Foreword ix Introduction x 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Quality system elements 2 4.1 General. 2 4.2 Management responsibility 2 4.3 Design control. 2 4.4 Measuring instruments and/or measur
36、ing systems 2 5 Product definition . 2 6 Process definitions. 3 7 User requirements 3 7.1 General. 3 7.2 Equipment characterization. 4 7.3 Product handling. 4 7.4 Microbiological and particulate environmental monitoring . 5 7.5 Cleaning and sterilization 5 7.6 Vent filter system 6 7.7 Lyophilizer le
37、ak test 6 8 Validation . 6 8.1 General. 6 8.2 Design qualification 6 8.3 Installation qualification. 6 8.4 Operational qualification 7 8.5 Performance qualification 9 8.6 Process validation 9 8.7 Review and approval of validation 10 9 Routine monitoring and control 10 9.1 General. 10 9.2 Operator tr
38、aining. 10 9.3 Standard operating procedures 11 9.4 Requalification 11 9.5 Maintenance of equipment. 11 9.6 Change control 11 Bibliography . 12 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For
39、 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. Other normatively referenced International Standards may be
40、 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 variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 IdenticalIEC 60601-2-2
41、: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/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendmen
42、t 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 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC 80601-2-58:2008
43、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/IEC TIR62348:2006 IdenticalISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identica
44、l 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 variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10
45、993-2:2006 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:
46、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 variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical I
47、SO 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
48、 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
49、-1:2007 Identical iv 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-3:2006 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 version)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
