1、ANSI/AAMI/ISO 81060-2:2013Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement typeAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or re
2、commended 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 current technologies to
3、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 that arbitrary and restric
4、tive 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 measurement techniques th
5、at 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 characteristics, instructi
6、ons 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 methods to facilitate uniform
7、ity 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 reasons for establishing t
8、he 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 help ensure that a device i
9、s 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, even though a recommende
10、d 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 guidelines to industrial p
11、ersonnel 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 practices. In determining wheth
12、er 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 regulatory or procurement au
13、thorities). 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 and industrial representat
14、ives, 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 recommended practice is limited
15、, 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 decision-making. Despite p
16、eriodic 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 specific rationale for eac
17、h 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 procedures and practices. While ob
18、served 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 identify a particular product a
19、s “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 in the context of the sp
20、ecific 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 useful only when it is use
21、d 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 made in writing, to the AAMI
22、 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 Association only upon exhaus
23、tion 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 recommended practice which has no
24、t 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 81060-2:2013 (Revision of ANSI/AAMI/ISO 81060-2:2009) Non-invasive sphygmomanometers Part 2:
25、 Clinical investigation of automated measurement type Approved 19 March 2013 by Association for the Advancement of Medical Instrumentation Approved 26 June 2013 by American National Standards Institute, Inc. Abstract: This standard specifies the requirements and methods for the clinical validation o
26、f medical electrical equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff. It is applicable to all sphygmomanometers that sense or display pulsations, flow, or sounds for the estimation, display, or recording of blood pressure. Thes
27、e sphygmomanometers need not have automatic cuff inflation. This standard covers sphygmomanometers intended for use in all patient populations (i.e. all age and weight ranges, and all conditions of use, e.g., ambulatory blood pressure monitoring, stress testing blood pressure monitoring). It is also
28、 applicable to the validation of electronically-controlled intermittent non-invasive blood pressure measurement medical electrical equipment, including blood pressure monitors for the home healthcare environment or self-measurement. Keywords: non-invasive blood pressure monitor, electromedical equip
29、ment, automated sphygmomanometer 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 anyone, whether they h
30、ave 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 standard may be rev
31、ised 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 standards by calling or writing AAMI, or by visiting the AAMI w
32、ebsite 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 user of the document. Occasionally, volunta
33、ry 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 Instrumentation 4301 N. Fairfax Drive, Suite 301 Arl
34、ington, VA 22203-1633 www.aami.org 2013 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 in any form, including an electronic retr
35、ieval 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 or externally) without the prior written p
36、ermission 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, complete the reprint request form at www.aami.o
37、rg 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 1-57020-511-6 Contents Page Glossary of equivalent standards iv Committee representation v Background of AAMI adoption of IEC 8
38、1060-2:2013 vi Foreword vii Introduction ix 1 Scope. 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements for CLINICAL INVESTIGATIONS 2 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER 3 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MO
39、NITORING EQUIPMENT . 18 7 * Pregnant (including pre-eclamptic) PATIENT populations 24 Annex A (informative) Rationale and guidance 25 Annex B (normative) Target heart rates for exercise stress testing 38 Annex C (informative) Reference to the essential principles 39 iv 2013 Association for the Advan
40、cement of Medical Instrumentation ANSI/AAMI/ISO 81060-2:2013 Glossary 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
41、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 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 81060-2:20
42、13 v Committee representation Association for the Advancement of Medical Instrumentation Sphygmomanometer Committee The adoption of ISO 81060-02 as a revision of ANSI/AAMI/ISO 81060-02:2009 was initiated by the AAMI Sphygmomanometer Committee, which serves as the U.S. TAG (technical advisory group)
43、for IEC/SC 62D and ISO/TC 121 Joint Working Group. U.S. representatives played an active role in developing the ISO standard. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Sphygmomano
44、meter Committee had the following members: Cochairs John W. Graves, MD David Quinn Members Bruce Stephen Alpert, MD, University of Tennessee Health Sciences Center Michael Joseph Bernstein, BS, Physio Monitor Jim Brown, Colder Products Company Richard A. Dart, MD, Marshfield Clinic Gerhard Frick, Mi
45、crolife Services AG Bruce A Friedman, D.Eng, GE Healthcare Jeff Gilham, Spacelabs Medical Inc. John W. Graves, MD, Mayo Clinic Clarence E. Grim, MS MD, Medical College of Wisconsin Michael Gutkin, MD FACP, Michael Gutkin MD LLC Charles S. Ho, PhD, FDA/CDRH Tsutomu Ichikawa, Omron Healthcare Co Ltd J
46、iri Jilek, Carditech Jack M. Millay, Accurate Blood Pressure Charles C. Monroe, Philips Electronics North America Bruce Z. Morgenstern, MD, Phoenix Childrens Hospital Yechiam Ostchega, PhD, RN, National Center for Health Statistics David Quinn, Welch Allyn Inc. Robert Smith, Robert M. Smith, MD, LLC
47、. Leonard Steinfeld, MD, Mount Sinai Hospital William B. White, MD, University of Connecticut Health Center J.S. Wiley, Draeger Medical Systems Inc. Colin Wu, Ph.D., National Heart Lung notes and examples: smaller roman type; test methods: italic type; terms defined in this document: SMALL CAPITALS
48、TYPE. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication o
49、f a new, amended or revised ISO or IEC publication in which to make products in accordance with the new viii 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 81060-2:2013 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of ISO/TC 121 and IEC/TC 62 that the content of this part of ISO 81060 not be adopted for mandatory implementation nationally 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 equi
