ANSI AAMI 13408-7-2012 Aseptic processing of health care products - Part 7 Alternative processes for medical devices and combination products.pdf

1、ANSI/AAMI/ISO 13408-7: 2012Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination productsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an

2、AAMI product standard or recommended practice 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

3、of current technologies to patient care, and (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

4、 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 th

5、e 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

6、 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 me

7、thods 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

8、 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

9、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. Similarl

10、y, 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

11、 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 prac

12、tices. 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 r

13、egulatory 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

14、 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 reco

15、mmended 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

16、 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

17、 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 procedu

18、res 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 iden

19、tify 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 analyz

20、ed 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

21、 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. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be m

22、ade 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 A

23、ssociation 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 recomm

24、ended 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. American National Standard ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products Part 7: A

25、lternative processes for medical devices and combination products Approved 20 July 2012 by Association for the Advancement of Medical Instrumentation Approved 26 July 2012 by American National Standards Institute Abstract: Specifies the requirements for, and offers guidance on, processes, programs a

26、nd procedures for procurement, development, validation, routine control of the manufacturing process and transport for aseptically processed cell based medical products (CBMP), especially tissue engineering products (TEPs) whose biological properties have to be kept intact to maintain their efficacy

27、 as a medical device and/or medicinal product. Keywords: CBMP, TEP, aseptic, combination product 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

28、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 th

29、e 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

30、 standards by calling or writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. 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 prof

31、essional 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 Association for the Advance

32、ment of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication ma

33、y 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 make copies of all or any part of this

34、 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 an

35、y part of this document, complete the reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-455-1 Contents Page Glossary of equivalent

36、standards . iv Committee representation . vii Background of ANSI/AAMI adoption of ISO 13408-7:2012 ix Foreword x Introduction . xi 1 Scope. 1 2 Normative references 1 3 Terms and definitions 1 4 Quality system elements . 2 5 Aseptic process definition 2 5.1 General 2 5.2 Risk management 2 6 Manufact

37、uring environment 3 7 Equipment . 3 8 Personnel 4 9 Manufacture of the product 4 10 Process simulation 4 10.1 General 4 10.2 Media selection and growth support . 4 10.3 Simulation procedures 4 10.4 Incubation and inspection of process simulation units 6 10.5 Initial performance qualification . 7 10.

38、6 Periodic performance requalification 7 10.7 Repeat of initial performance qualification . 8 10.8 Documentation of process simulations. 8 10.9 Disposition of filled product . 8 11 Test for sterility 8 11.1 General 8 11.2 Investigation of positive units from tests for sterility 8 Annex A (informativ

39、e) Risk assessment for aseptic processing Quality risk management method 9 Annex B (informative) Selection of a sample for testing for microbial contamination 16 Annex C (informative) Testing options for process simulation 18 Bibliography . 22 iv 2012 Association for the Advancement of Medical Instr

40、umentation ANSI/AAMI/ISO 13408-7:2012 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 correspon

41、ding 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 10993-4:2002/(R)2009 indicates that 10993

42、-4, originally approved and published in 2002, was reaffirmed without change in 2009. 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 Equiva

43、lency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 biodegradable implants (e.g. herni

44、a meshes); artificial and/or non-viable biologically based matrixes; extracorporeal processing devices (e.g. immuno-adsorbers); implantable osmotic pumps; hermetically sealed electromechanical devices and partially enclosed electronic devices (e.g. invasive and non-invasive diagnostic devices). b) C

45、ombination products (including viable cell-based combination products): implants coated with drug and/or biologically derived substances (e.g. drug-coated stents, carrier materials with protein, bone-graft material with growth factors, biodegradable drug-coated stents); wound dressings (e.g. dressin

46、gs with hemostatic agents, tissue sealants, or biologics); transdermal or injectable delivery systems (e.g. drug-coated or biologics interstitial patches); kits containing a biological or drug component (e.g. demineralized bone matrices). For such products, a risk management strategy and method(s) c

47、an be used for the identification, evaluation and quantification (estimation) of contamination risks throughout the entire product/process life cycle. Environmental monitoring and microbiological studies can be performed on individual steps of the process to evaluate the effectiveness of contaminati

48、on controls and risk mitigations. The design of the xii 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-7:2012 process simulation can then be driven by the results of the risk analysis. If the results of the process simulation are acceptable, this provides evidenc

49、e that the aseptic process is in a state of contamination control (i.e. no extrinsic microbiological/microbial contamination has been introduced during the aseptic process). This part of ISO 13408 should be read in conjunction with ISO 13408-1. Within this International Standard, text that supplements ISO 13408-1 by providing additional requirements or guidance is identified by the prefix “Addition”. 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13408-7:2012 1 American National Standard ANSI/AAMI/ISO 13408-7:2012 1 Sc