1、ANSI/AAMI/ISO 22442-2: 2016Medical devices utilizing animal tissues and their derivativesPart 2: Controls on sourcing, collection and handlingAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AA
2、MI 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 of
3、 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 t
4、hat 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 the
5、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 c
6、haracteristics, 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 meth
7、ods 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 r
8、easons 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 he
9、lp 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. Similarly,
10、 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 g
11、uidelines 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 practi
12、ces. 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 reg
13、ulatory 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 a
14、nd 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 recomm
15、ended 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 d
16、ecision-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 s
17、pecific 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 procedure
18、s 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 identi
19、fy 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 analyzed
20、 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 u
21、seful 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 mad
22、e 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 Ass
23、ociation 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 recommen
24、ded 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 22442-2:2016 Medical devices utilizing animal tissues and their der
25、ivativesPart 2: Controls on sourcing, collection and handling Approved 29 April 2016 by AAMI Approved 17 November 2016 by American National Standards Institute Abstract: Specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and
26、 tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. Keywords: collection, sourcing, handling, animal tissue AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consen
27、sus 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 the
28、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 y
29、ears 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 applicati
30、on 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 regulation
31、s. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 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 dis
32、tributed 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 int
33、ernally 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 documen
34、t, complete 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: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020- 667-2 Contents Page Glossary of equivalent standards iv Committee
35、representation v Background of ANSI/AAMI adoption of ISO 22442-2:2016 vi Foreword vii Introduction viii 1 Scope. 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 2 5 Sourcing 4 6 Collection 5 7 Handling 5 8 Storage and transport 6 Annex A (normative) Additional requirement
36、s relating to the application of this part of ISO 22442 to bovine-sourced materials . 7 Annex B (informative) Certification and attestation . 12 Annex C (informative) Veterinary services 14 Bibliography 15 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 22442-2:2016 G
37、lossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address
38、below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 22442-2:2016 v Committee representation Association for the Advancement o
39、f Medical Instrumentation Tissue Product Safety Committee The adoption of ISO 22442-2 as an AAMI standard was initiated by the AAMI Tissue Product Safety Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO
40、). U.S. representatives from the AAMI Tissue Product Safety Committee (U.S. TAG for ISO/TC 194/SC 1), chaired by Rich Hutchinson and Scott McNamee, played an active part in developing the ISO Standard. Committee approval of this document does not necessarily imply that all committee members voted fo
41、r its approval. At the time this standard was published, the AAMI Tissue Product Safety Committee had the following members: Cochairs: Richard Hutchinson Scott McNamee Members: Crystal Anderson-Cunanan, Boston Scientific Corporation Scott Brubaker, American Association of Tissue Banks Kim Darnell, C
42、R Bard Steven Elliott, NAMSA Gary Fischman, National Academies Deborah Gessell-Lee, Baxter Healthcare Corporation Richard Hutchinson, Johnson b) there has been no case of BSE; c) there has been no feeding of mammalian-derived protein; d) there is a fully documented breeding history; e) there is a fu
43、lly documented use of veterinary medicines and vaccines; f) each animal is traceable; g) genetic material has been introduced only from herds with the same BSE-free status Note 1 to entry: By analogy, low risk herd is applicable to other species naturally affected by TSE. Additional precautionary me
44、asures may be required. 3.3 veterinarian person designated by the relevant competent authority as suitably qualified for the responsibility delegated to him or her relating to ante- and post-mortem inspection of animals and/or relevant certification Note 1 to entry: Under certain jurisdictions, it i
45、s a requirement that the veterinarian be a professionally qualified person in veterinary medicine. Note 2 to entry: Under certain jurisdictions, the function of inspection and of certification can be carried out by different individuals. In such cases, the certificate can be signed by a person who i
46、s not designated by the competent authority. This function is covered in the quality management system of the medical device manufacturer. 4 General requirements 4.1 General Apply the requirements of this part of ISO 22442 as determined by the risk assessment (see ISO 22442-1). Annex A shall be appl
47、ied as appropriate. 4.2 Quality system elements A documented system shall be established and maintained to control the quality of materials of animal origin and shall be verified by the medical device manufacturer. Specific requirements relating to collection are included in Clause 6. This system sh
48、all address the animal source and the following factors: a) specification of the geographical origin (such as country or region) of the animal material, state of health of the animals, and acceptance criteria for animals taking into account the source-species, perceived risk from pathogens, and abil
49、ity to obtain appropriate assurances; NOTE 1 The geographical origin can include the animals place of birth and the countries or regions in which it has lived during its lifetime as well as its place of slaughter. It is advisable that the manufacturer document the extent to which the geographical origin of the animal can be traced taking into account the application of risk management (see ISO 22442-1). b) hygiene and quality assurance requirements to be met by the slaughterer including the provisions in the slaughterhouse to prevent cross-contamination within and between an
