1、ANSI/AAMI/ISO 13022: 2012Medical products containing viable human cells Application of risk management and requirements for processing practicesAmerican 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 13022:2012 Medical products containing viable human cells Applica
25、tion of risk management and requirements for processing practices Approved 3 May 2012 by Association for the Advancement of Medical Instrumentation Approved 18 June 2012 by American National Standards Institute, Inc. Abstract: Specifies a procedure to identify the hazards and hazardous situations an
26、d to manage the risk associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof. Covers viable human materials of autologous as well as allogeneic human origin. Keywords: risk man
27、agement, biological evaluation, tissue engineering, cellular, biologics 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
28、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 the latest editions. CAUTIO
29、N 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 date of publication. Interested parties may obtain current information on all AAMI standards by calling
30、or writing AAMI, or by visiting the AAMI website at www.aami.org. 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 professional judgment of the u
31、ser 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 Advancement of Medical Instrument
32、ation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 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 may be reproduced or distributed
33、 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 document (whether internally
34、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 any part of this document, compl
35、ete the reprint request form at www.aami.org or contact AAMI, 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 1570204470 Contents Page Glossary of equivalent standards . v Committee representation
36、vii Background of AAMI adoption of ISO 13022:2012 . ix Foreword x Introduction xi 1 Scope. 1 2 Normative references 2 3 Terms and definitions 2 4 Risk management process . 7 4.1 General 7 4.2 Hazards associated with the cellular component . 8 4.3 Risk analysis 9 4.4 Risk evaluation . 11 4.5 Risk con
37、trol 11 4.6 Evaluation of overall residual risk acceptability . 11 4.7 Production and post-production information system 12 Annex A (informative) Guidance on the application of ISO 13022 13 Annex B (informative) Graphic representation of the part of the risk management process for cell-based medical
38、 products . 14 Annex C (normative) Requirements for donor selection and testing . 15 Annex D (informative) Guidance for tissue procurement . 20 Annex E (normative) Requirements for handling of cells and tissue during manufacture 23 Annex F (normative) Requirements for packaging and labeling . 26 Ann
39、ex G (informative) Guidance for transport 30 Annex H (informative) Guidance for storage . 36 Annex I (normative) Requirements for traceability . 40 Annex J (normative) Risk reduction measures related to contamination with viruses and other infectious agents such as TSE . 41 Annex K (informative) Gui
40、dance with regard to hazards caused by the tumorigenic potential of the human cells/tissues used for the production of medical products . 44 Annex L (informative) Guidance with regard to microbiological contamination . 45 Annex M (informative) Guidance with regard to potential adverse effects of non
41、-cellular residues of the product . 46 Annex N (normative) Requirements with regard to potential adverse effects of the cellular components of a medical product . 47 Annex O (informative) Guidance for the characterization of the cellular components of a medical product . 49 Annex P (informative) Cli
42、nical evaluation and testing 53 Bibliography 54 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13022:2012 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each
43、 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. The code in the US column, “(R)20xx” indicates the year the docu
44、ment was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, 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; theref
45、ore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical vari
46、ations C1 Identical to Corrigendum 1 b) the material can be contaminated with chemicals; c) the material can be unsuitable for the intended purpose due to unintended decomposition or degradation induced by inappropriate handling at any stage of the production process; d) the material can be hazardou
47、s for the patient due to tumorigenic potential; e) following application, unintended physiological and anatomical consequences can be hazardous, taking into account cell migration and release of biologically active substances; f) a failure of traceability; g) the material can cause harm for the pati
48、ent by eliciting an immunogenic reaction. To address the hazards related to contamination, degradation, unintended modification and/or mix-up of viable human cells and products, this International Standard was developed for the application of risk management on the manufacture of medical products ut
49、ilizing viable human material. The hazards mentioned above have been related to the relevant manufacturing steps. The essential aspects to be covered by this International Standard are as follows: terminology and definitions; donor selection and testing, addressing both living and deceased donors; human material procurement; human material handling (including production); human material packaging, storage and transport; human material labeling; xii 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13022:2012 risk related to handlin
