1、ANSI/AAMI/ISO 16142-2: 2017Medical devicesRecognized essential principles of safety and performance of medical devicesPart 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standardsAmerican National StandardObje
2、ctives 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 practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement
3、 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 (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly
4、 to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided 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
5、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 determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics
6、of different products. Some standards emphasize the information that should be provided with the device, including performance 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 env
7、ironment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that
8、clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the 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 devic
9、e 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 effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it
10、 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 usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in wh
11、ich a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other pr
12、ocessing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. 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
13、be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the docu
14、ment. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or rec
15、ommended 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 sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A stan
16、dard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible 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 dyna
17、mic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the 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 tak
18、en in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professio
19、nal 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 voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account th
20、e 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 resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is
21、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 with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS
22、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, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subse
23、quently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association 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 A
24、dvancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretatio
25、n in the AAMI News. American National Standard ANSI/AAMI/ISO 16142-2:2017 Medical devicesRecognized essential principles of safety and performance of medical devicesPart 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selec
26、tion of standards Approved 4 June 2017 by AAMI Approved 31 July 2017 by American National Standards Institute, Inc. Abstract: This part of ISO 16142, which includes the essential principles of safety and performance, identifiessignificant standards and guides that can be used in the assessment of co
27、nformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This standard identifies and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medica
28、l devices (in vitro diagnostic). Keywords: medical device, essential principles, IVDAAMI 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
29、 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 the latest edit
30、ions. 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 years from the date of publication. Interested parties may obtain current information on all AAMI standards
31、 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 application is solely within the discretion and professional judgment of the user of the document. Occasionally, vo
32、luntary 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 AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the As
33、sociation 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 distributed in any form, including an electronic retrieval system, without the prior written permission of AA
34、MI. 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 or externally) without the prior written permission of the Association for the Advancement of Medi
35、cal 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, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Ar
36、lington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-671-9 Contents Page Glossary of equivalent standards iv Committee representation . v Background of ANSI/AAMI adoption of ISO 16142-2:2017 vi Foreword . vii Introduction . vi
37、ii 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 4 Essential principles of safety and performance of IVD medical devices 8 5 Use of standards and guides in support of the essential principles. 9 6 Essential principles and references to relevant standards and guides 14 Annex A (informa
38、tive) Rationale and guidance 16 Annex B (normative) Table relating essential principles to standards 18 Annex C (informative) Website listings of other standards suitable for the medical device sector and for assessment purposes . 35 Annex D (informative) Reference to the essential principles by Int
39、ernational Standards 36 Annex E (informative) TerminologyAlphabetized index of defined terms 42 Bibliography . 43 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 16142-2:2017 Glossary of equivalent standards International Standards adopted in the United States may inc
40、lude 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 below, this list gives the corresponding U.S. designation and level of equivalency to the In
41、ternational Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 16142-2:2017 v Committee representation Association for the Advancement of Medical Instrumentation General aspects stemming from the application of quality principle
42、s to medical devices The publication of AAMI/ISO 16142-2:2017 as a new American National Standard was initiated by the AAMI General aspects stemming from the application of quality principles to medical devices Work Group, which also functions as a U.S. Technical Advisory Group to the relevant work
43、in the International Organization for Standardization (ISO) ISO/TC210 WG2. U.S. representatives from the AAMI General aspects stemming from the application of quality principles to medical devices Work Group participate as US experts on the ISO committee. At the time this document was published, the
44、 AAMI General aspects stemming from the application of quality principles to medical devices Work Group had the following members: Cochair: Carol Herman (through October 2016) Dave Osborn (pro-tem) Members: Kathie Bardwell, Steris Corporation Ali Calik, Bausch informative material appearing outside
45、of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; terms defined in Clause 3: bold. In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. For the pu
46、rposes of this document, the auxiliary verb 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 16142-2:2017 ix “shall” means that compliance with a requirement or a test is mandatory for compliance with this document, “should” means that compliance with a requirement or a t
47、est is recommended but is not mandatory for compliance with this document, “may” is used to describe a permissible way to achieve compliance with a requirement or test, and “must” is used to describe an external constraint, but is not mandatory for compliance with this document. An asterisk (*) as t
48、he first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A. The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period fol
49、lowing publication of a new, amended or revised ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. 2017 Association for the Advancement of Medical Instrumentation ANSI/AA
