1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 11607-2:2006/(R)2010Packaging for terminally sterilized medical devicesPart 2: Validation requirements for forming, sealing, and assembly processesThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most impor
2、tant that the objectives and potential uses of an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedin
3、crease in the safe and effective application of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with a
4、ttention to theseobjectives and provided that arbitrary and restrictive uses are avoided.A voluntary standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifyi
5、ng the device for clinical use, and the measurementtechniques that can be used to determine whether the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided
6、with the device,including performance characteristics, instructions for use, warningsand precautions, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the d
7、evelopment of specialized test methods to facilitateuniformity in reporting; reaching consensus on these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee t
8、ests must beprovided and the reasons for establishing the criteria must bedocumented in the rationale.A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures a
9、nd practices that will help ensure that a device is usedsafely and effectively and that its performance will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device
10、evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance c
11、riteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, methods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding ind
12、ustrial practices.In determining whether an AAMI standard or recommendedpractice is relevant to the specific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by gover
13、nment regulatory orprocurement authorities). The application of a standard or recom-mended practice is solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professio
14、nals andindustrial representatives, whose work has been reviewed nationally(and sometimes internationally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recom
15、mended practice is limited,however, in the sense that it responds generally to perceived risks andconditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecis
16、ion-making.Despite periodic review and revision (at least once every fiveyears), a standard or recommended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific r
17、ationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to the specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practice
18、s. While observed orpotential risks with existing equipment typically form the basis for thesafety and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular p
19、roduct as “unsafe“. A voluntary standard can be used asone resource, but the ultimate decision as to product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of th
20、e specific needs andresources of the individual institution or firm. Again, the rationaleaccompanying each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used
21、 in conjunction with other sources of informationand policy guidance and in the context of professional experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for
22、 TechnicalDevelopment. An official interpretation must be approved by letterballot of the originating committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon
23、publication of notice of interpre-tation in the “Standards Monitor“ section of the AAMI News. TheAssociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicate
24、d in accordance with this procedure and which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 11607-2:2006/(R)2010 (Revision of ANSI/AAMI/ISO 11607:2000) Packaging for terminally sterilized medical devicesPart 2: Validati
25、on requirements for forming, sealing, and assembly processes Approved 9 December 2005 by Association for the Advancement of Medical Instrumentation Approved 23 December 2005 and reaffirmed 14 December 2010 by American National Standards Institute Abstract: Specifies the requirements for development
26、and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems. Keywords: barrier system,
27、qualification, validation 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 app
28、roved 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
29、 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 date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommend
30、ed 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 regu
31、latory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the Association for the Ad
32、vancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and 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 reque
33、sts pertaining to this draft 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 externally) without the prior written permission of the Association for the Advancement of Medical Instrumentat
34、ion. 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, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Prin
35、ted in the United States of America ISBN 1570202524 Contents Glossary of equivalent standards . iv Committee representation vi Background of AAMI adoption of ISO 11607-2:2006 . ix Foreword. x Introduction . xi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 4
36、4.1 Quality systems. 4 4.2 Sampling 4 4.3 Test methods. 5 4.4 Documentation 5 5 Validation of packaging processes. 5 5.1 General. 5 5.2 Installation qualification (IQ) 6 5.3 Operational qualification (OQ). 7 5.4 Performance qualification (PQ) . 8 5.5 Formal approval of the process validation. 8 5.6
37、Process control and monitoring 8 5.7 Process changes and revalidation 9 6 Packaging system assembly . 9 7 Use of reusable sterile barrier systems 9 8 Sterile fluid-path packaging. 10 Annex A (informative) Process development 11 Bibliography . 12 iv 2006 Association for the Advancement of Medical Ins
38、trumentation ANSI/AAMI/ISO 11607-2:2006 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 corresp
39、onding U.S. designation and level of equivalency to the international standard. (NOTEDocuments are sorted by international designation.) Other normatively referenced international standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive
40、. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 606
41、01-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI 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 60601-2-2
42、4:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC TR 62348:200x1 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7
43、198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:200
44、2 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 ANSI/AAMI BE78:2002 Minor tech
45、nical variations ISO 10993-11:1993 ANSI/AAMI 10993-11:1993 Minor technical variations ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-
46、15:2000 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO TS 10993-19:200x1ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO TS 10993-20:200x1ANSI/AAMI/ISO TIR10993-20:2006 Identical 2006 Association for the Advancement o
47、f Medical Instrumentation ANSI/AAMI/ISO 11607-2:2006 v International designation U.S. designation Equivalency ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:200x1 ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:200x1 ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:200x1 ANSI/AAMI/IS
48、O 11137-3:2006 Identical ISO 11138-1: 200x1ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 200x1ANSI/AAMI/ISO 11138-2:2006 Identical ISO 11138-3:1995 ANSI/AAMI ST19:1999 Major technical variations ISO 11138-4: 200x1ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 200x1ANSI/AAMI/ISO 11138-5:2006 I
49、dentical ISO TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-5:2000 ANSI/AAMI ST66:1999 Major technical variations 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 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 13488:1996 ANSI/AAMI/ISO 13488:1996 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identical ISO 14155-2:2003 ANSI/AAMI/I
