1、ANSI/AAMI/ISO 16142-1:2016Medical devicesRecognized essential principles of safety and performance of medical devicesPart 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standardsAmerican National StandardO
2、bjectives 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 advancem
3、ent 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 significan
4、tly 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
5、on 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 characteristi
6、cs 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
7、environment. 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 th
8、at 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 de
9、vice 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,
10、 it 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
11、 which 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
12、 processing 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 mu
13、st 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 d
14、ocument. 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
15、recommended 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 s
16、tandard 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 d
17、ynamic 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
18、taken 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, profes
19、sional 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
20、 the 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
21、is 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. INTERPRETATIO
22、NS 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 su
23、bsequently 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 th
24、e Advancement 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 interpreta
25、tion in the AAMI News. American National Standard ANSI/AAMI/ISO 16142-1:2016 Medical devicesRecognized essential principles of safety and performance of medical devicesPart 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on th
26、e selection of standards Approved 5 June 2016 by Association for the Advancement of Medical Instrumentation Approved 7 July 2016 by American National Standards Institute Abstract: This part of ISO 16142, identifies significant standards and guides that can be used in the assessment of conformity of
27、a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic). Keywo
28、rds: medical device, essential principles, non-IVD 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 anyo
29、ne, 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. CAUTION NOTICE: This AAMI s
30、tandard 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 or writing AAMI. All
31、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, voluntary technical documents are a
32、dopted 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 Instrumentation 4301 N Fairfax Drive, Suite 301 Arlington, VA 22203-1633 2016 by
33、 the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written p
34、ermission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 Associ
35、ation 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, complete the reprint request form at www.aami.org or contact AAMI at 4
36、301 N Fairfax Drive, Suite 301, Arlington, VA 22203- 1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 1-57020-616-3 Contents Page Glossary of equivalent standards iv Committee representation . v Background of ANSI/AAMI adoption of ISO 16142-1:2016 vi For
37、eword . vii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions 9 4 Essential principles of safety and performance of medical devices . 13 5 Use of standards and guides in support of the essential principles. 13 6 Essential principles and references to relevant standards and
38、 guides 18 Annex A (informative) Rationale and guidance 20 Annex B (normative) Table relating essential principles to standards 22 Annex C (informative) Website listings of other standards suitable for the medical device sector and for assessment purposes . 42 Annex D (informative) Reference to the
39、essential principles by International Standards 43 Annex E (informative) Terminologyalphabetized index of defined terms 49 Bibliography . 50 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI m
40、aintains 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 International Standard. www.aami.org/standards/glossary.pdf iv 2016
41、Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 16142-1:2016 Committee representation Association for the Advancement of Medical Instrumentation General aspects stemming from the application of quality principles to medical devices The publication of ANSI/AAMI/ISO 16142-1:20
42、16 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 in the International Organization for Standardization (ISO)
43、 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 AAMI General aspects stemming from the application of qual
44、ity principles to medical devices Work Group had the following members: Cochair: Carol Herman, AAMI Members: Kathie Bardwell, Steris Corporation Ali Calik, Bausch the standard has been developed in two parts, one for non-IVD (in vitro diagnostic) medical devices and one for IVD medical devices; the
45、essential principles were harmonized with the most recent Global Harmonization Task Force recommendation5, as well as other major jurisdictions (e.g. U.S. FDA regulation the relevant aspects of the draft European Medical Device Regulation6); a much more thorough mapping of published reference standa
46、rds to the essential principles has been included; this part of ISO 16142 also includes a more comprehensive description of the use of standards as a tool to demonstrate that a medical device is clinically effective and performs in a safe manner where the medical benefits of the use of the medical d
47、evice outweigh the risk of the use to the patient; this part of ISO 16142 also includes an informative annex as a template for writers of medical device related standards where the content of their standard is mapped to the essential principles. 2016 Association for the Advancement of Medical Instru
48、mentation ANSI/AAMI/ISO 16142-1:2016 vii ISO 16142 consists of the following parts, under the general title Medical devicesRecognized essential principles of safety and performance of medical devices: Part 1: General essential principles and additional specific essential principles for all non-IVD m
49、edical devices and guidance on the selection of standards The following parts are under preparation: Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards viii 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 16142-1:2016 Introduction Standards and standardization processes can be made more effective by developing a better understanding of the needs and requirements of those who use or who are affected by standards. Improveme
