1、ANSI/AAMI/ISO 81060-1:2007/(R)2013Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-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 pr
2、oduct 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 curr
3、ent 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 that a
4、rbitrary 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 measu
5、rement 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 charac
6、teristics, 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 methods t
7、o 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 reason
8、s 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 help en
9、sure 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, even
10、 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 guidel
11、ines 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 practices.
12、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 regulato
13、ry 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 and in
14、dustrial 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 recommended
15、 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 decisi
16、on-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 specif
17、ic 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 procedures and
18、 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 identify a
19、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 in t
20、he 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 useful
21、 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 made in
22、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 Associat
23、ion 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 recommended p
24、ractice 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 81060-1:2007/(R)2013 Non-invasive sphygmomanometers Part 1: Requirements
25、 and test methods for non-automated measurement type Approved 18 March 2008 by Association for the Advancement of Medical Instrumentation Approved 1 May 2008 and reaffirmed 26 June 2013 by American National Standards Institute, Inc. Abstract: This standard specifies requirements for mechanical sphyg
26、momanometers and their accessories that, by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labeling, for these instruments and their accessories, including t
27、est methods to determine the accuracy of their measurements. The standard covers non-invasive blood pressure measuring devices with a mechanical pressure sensing element and display used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds. Keywords: sphygmomanome
28、ter, blood pressure 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 have approved
29、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 revised or withd
30、rawn 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 AAMI standards, recommended pra
31、ctices, 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 adopted by government regulatory
32、 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 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2008 by the Association for
33、 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 retrieval system, without the prior written permission of AAMI. Al
34、l 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 Medical In
35、strumentation. 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-
36、1067. Printed in the United States of America ISBN 1-57020-314-8 Contents Page Glossary of equivalent standards v Committee representation. vii Background of AAMI Adoption of ISO 81060-1:2007 viii AAMI inclusion to ISO 81060-1:2007 . ix Foreword. x Introduction . xi 1 * Scope . 1 2 Normative referen
37、ces . 1 3 Terms and definitions. 2 4 Identification and marking . 5 4.1 * Units of measurement 5 4.2 * Legibility of markings. 5 4.3 * Durability of markings 6 4.4 * Marking of non-automated sphygmomanometer 6 4.5 * Usability of reading 7 4.6 Marking of the cuff 7 4.7 Marking of the non-automated sp
38、hygmomanometer packaging. 7 5 General requirements for testing non-automated sphygmomanometers 7 5.1 * Type tests 7 5.2 * Representative sample 7 5.3 Environmental conditions 8 5.4 Repairs and modifications . 8 5.5 * Humidity preconditioning treatment. 8 6 General requirements. 8 6.1 General. 8 6.2
39、Electrical safety. 9 6.3 Mechanical safety . 9 6.4 Mechanical strength . 9 7 Requirements 11 7.1 Pressure indicating means 11 7.2 Pneumatic system. 12 7.3 * Tamper proofing or unauthorized access 15 7.4 Dynamic response in normal use 15 8 Additional requirements for non-automated sphygmomanometer wi
40、th mercury manometer. 16 8.1 * Internal diameter of the tube containing mercury. 16 8.2 * Portable non-automated sphygmomanometer 16 8.3 * Prevention of mercury spillage during transport 16 8.4 * Prevention of mercury spillage in normal use 16 8.5 Quality of the mercury 17 9 Non-automated sphygmoman
41、ometers with aneroid manometer.17 9.1 * Scale mark at zero 17 9.2 * Zero 17 9.3 Hysteresis error. 18 9.4 * Construction and materials . 18 10 Cleaning, sterilization and disinfection 19 10.1 Reusable non-automated sphygmomanometer and parts . 19 10.2 Non-automated sphygmomanometer and parts requirin
42、g processing before use 19 10.3 Non-automated sphygmomanometer and parts delivered sterile . 19 11 Biocompatibility 19 12 Information supplied by the manufacturer. 20 12.1 Accompanying document 20 12.2 Instructions for use. 20 12.3 Technical description . 23 Annex A (informative) Rationale and guida
43、nce. 25 Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury manometer. 34 Annex C (informative) Environmental aspects 35 Annex D (informative) Reference to the essential principals. 36 Annex E (informative) Terminology Alphabetized index of defined terms 38 Bibliogr
44、aphy . 39 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 81060-1:2007 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has bee
45、n 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. Other normatively referenced International Standards may be under consideration for U.S. adoption by
46、 AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Ident
47、ical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IE
48、C 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:
49、2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10
