ANSI AAMI 80601-2-30-2009 Medical electrical equipment - Part 2-30 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometer.pdf

1、ANSI/AAMI/IEC 80601-2-30:2009 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 es

2、tablishing 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 ensure tha

3、t 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 though

4、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 guidelines to

5、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. In deter

6、mining 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 regulatory or pr

7、ocurement 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 industrial

8、 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 practic

9、e 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 decision-makin

10、g. 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 specific ratio

11、nale 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 practic

12、es. 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 particul

13、ar 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 the conte

14、xt 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 only wh

15、en 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 writing,

16、 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 Association only

17、 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 practice

18、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/IEC 80601-2-30:2009 and ANSI/AAMI/IEC 80601-2-30:2009/C1:2009/(R)2016 (Consolidated

19、Text) Medical Electrical Equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Approved 18 June 2009 by AAMIApproved 24 July 2009 Amendment C1 approved 10 December 2009 and reaffirmed 20 December 2016 byAmerican Nation

20、al Standards Institute, Inc. Abstract: This standard applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff, are used for intermittent indirect measurement of the blood pressure without arterial pressure. . Keywords: automated sphyg

21、momanometer, blood pressure, non-automated sphygmomanometer, non-invasive blood pressure measurement 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 A

22、AMI 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 standard. AAMI standards are subject to periodic review, and users are cautioned to obtai

23、n 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 5 years from the date of publication. Interested parties may obtain current information on all

24、AAMI standards by calling or writing AAM, or by visiting the AAMI website 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 profe

25、ssional 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 regulations. Published by AAMI4301 N Fairfax Drive, Su

26、ite 301Arlington, VA 22203-1633www.aami.org 2009 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IEC and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic re

27、trieval 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

28、 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 document, complete the reprint request form at www.aami

29、.org or contact AAMI, 1301 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 978-1-57020-357-2Contents Page Glossary of equivalent standards v Committee representation. vii Background of AAMI adoption of IEC

30、 80601-2-30:2009 .viii AAMI inclusion to IEC 80601-2-30:2009 . ix FOREWORD x INTRODUCTION xiii 201.1 Scope, object and related standards1 201.2 Normative references3 201.3 Terms and definitions4 201.4 General requirements .6 201.5 General requirements for testing ME EQUIPMENT .7 201.6 Classification

31、 of ME EQUIPMENT and ME SYSTEMS 7 201.7 ME EQUIPMENT identification, marking and documents 7 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 11 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS. 11 201.10 Protection against unwanted and excessive radiation HAZA

32、RDS. 12 201.11 Protection against excessive temperatures and other HAZARDS. 12 201.12 Accuracy of controls and instruments and protection against hazardous outputs 13 201.13 HAZARDOUS SITUATIONS and fault conditions . 17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 17 201.15 Construction of

33、 ME EQUIPMENT . 17 201.16 ME SYSTEMS 19 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 20 201.101 Requirements for CUFFS 20 201.102 Connection tubing and CUFF connectors 20 201.103 Unauthorized access. 20 201.104 * Maximum inflating time . 21 201.105 * Automatic cycling modes. 2

34、2 201.106 * Clinical accuracy. 26 202 Electromagnetic compatibility Requirements and tests 26 Annexes. 30 Annex C (informative) Guide to marking and labeling requirements for ME EQUIPMENT and ME SYSTEMS 31 Annex AA (informative) Particular guidance and rationale. 35 Annex BB (informative) Environmen

35、tal aspects 44 Annex CC (informative) Reference to the essential principles . 45 Bibliography . 47 Index of defined terms 49 Figure 201.101 CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLEFAULT CONDITION . 15 Figure 201.102 CUFF pressure PROTECTION DEVICE, triggered by prolonged

36、overpressure in SINGLE FAULT CONDITION. 16 Figure 201.103 CUFF pressure and maximum inflation time, NORMAL CONDITION and SINGLE FAULT CONDITION 22 Figure 201.104 LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION 23 Figure 201.105 LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDIT

37、ION 23 Figure 201.106 SHORT-TERM AUTOMATIC MODE CUFF pressure 24 Figure 201.107 SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure 25 Figure 202.101 HF SURGICAL EQUIPMENT test layout. 29 Figure 202.102 Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 30 Table 201.101 Distributed ESSENTIAL PERFOR

38、MANCE requirements .7 Table 201.102 CUFF deflation pressure 12 Table 201.103 CUFF inflation pressure . 21 Table 201.C.101 Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their parts 31 Table 201.C.102 Marking of controls and instruments of AUTOMATEDSPHYGMOMANOMETERS or their parts 32 Table

39、201.C.103 ACCOMPANYING DOCUMENTS, general information for AUTOMATEDSPHYGMOMANOMETERS. 32 Table 201.C.104 ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATEDSPHYGMOMANOMETERS. 32 Table 201.C.105 ACCOMPANYING DOCUMENTS, technical description of AUTOMATEDSPHYGMOMANOMETERS. 34 Table AA.1 Summary o

40、f requirements by mode 41 Table BB.1 Environmental aspects addressed by clauses of this standard 44 Table CC.1 Correspondence between this particular standard and the essential principles . 45 Glossary of equivalent standards International Standards adopted in the United States may include normative

41、 references to other International Standards. For each International Standard that has been 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 norm

42、atively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 ANSI/AAMI ES60601-

43、1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 and 2 IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 IdenticalIEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 IdenticalIEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 6

44、0601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-5

45、0:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 IdenticalIEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2009 IdenticalIEC 62

46、304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 IdenticalIEC/TR 80002-1:2009 ANSI/IEC/TR 80002-1:2009 IdenticalISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 I

47、dentical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2009 ANSI/AAMI/ISO 10993-1:2009 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Identical

48、ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 Identical ISO 10993-5:2009 ANSI/AAMI/ISO 10993-5:2009 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:1999 ANSI/AAMI

49、/ISO 10993-9:1999/(R)2005 IdenticalISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2009 Identical ISO 10993