1、ANSI/AAMI/IEC 60601-2-16:2012Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipmentAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most
2、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 of medical instrumentation. Essential to such advancement are (1) a co
3、ntinued 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 to the advancement of medical instrumentation, provided that they are
4、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 the product, basic safety and performance criteria that should be consi
5、dered 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 of different products. Some standards emphasize the information that sh
6、ould 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 environment. Recommending the disclosure of performance characteristics of
7、ten 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 clinical concerns warrant the establishment of minimum safety and perfo
8、rmance 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 device or system. A recommended practice does not address device performance
9、 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 may also be of value to the potential purchaser or user of the device
10、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 which a medical device will be used. Also, some recommended practices, wh
11、ile 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 processing or evaluation techniques; such guidelines may be useful to hea
12、lth 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 be recognized: All AAMI standards and recommended practices are volunta
13、ry (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 document. Each AAMI standard or recommended practice reflects the collectiv
14、e 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 recommended practice are intended to respond to clinical needs and, ultima
15、tely, 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 standard or recommended practice is an important reference in responsible d
16、ecision-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 dynamic technology. Therefore, a standards user must carefully review the r
17、easons 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 taken in applying a product standard to existing devices and equipment, an
18、d 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, professional judgment must be used in applying these criteria to existing equipm
19、ent. 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 the specifics of its utilization and, of course, cost-benefit considerati
20、ons. 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 an excellent guide to the reasoning and data underlying its provision.
21、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 OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretation
22、s 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 subsequently reviewed and approved by the AAMI Standards Board. The interpre
23、tation 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 Advancement of Medical Instrumentation disclaims responsibility for any
24、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 interpretation in the AAMI News. American National Standard ANSI/AAMI/IEC 60601-2-16
25、:2012 (Revision of ANSI/AAMI/IEC 60601-2-16:2008) Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment Approved 20 August 2012 by Association for the Advancement of Medical Instrumen
26、tation Approved 5 September 2012 by American National Standards Institute, Inc. Abstract: Specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of
27、medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient. Keywords: medical equipment, blood, dialysis, packaging, marking, labeling AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consen
28、sus 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 the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the
29、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 withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five y
30、ears 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 website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents dev
31、eloped 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 agencies or procurement authorities, in which case the adopting agency is respon
32、sible 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 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publicati
33、on 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. All requests pertaining to this document should be submitted to AAMI. It is ille
34、gal 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 Instrumentation. Violators risk legal action, including civil and criminal penal
35、ties, 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, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the
36、 United States of America ISBN 1570204586 CONTENTS Glossary of equivalent standards v Committee representation . viii Background of AAMI adoption of IEC 60601-2-16:2012 . x FOREWORD xi INTRODUCTION xiv 201.1 Scope, object and related standards 1 201.2 Normative references . 3 201.3 Terms and definit
37、ions 4 201.4 General requirements 6 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 15 201.9 Protection again
38、st MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 16 201.10 Protection against unwanted and excessive radiation HAZARDS 16 201.11 Protection against excessive temperatures and other HAZARDS 16 201.12 * Accuracy of controls and instruments and protection against hazardous outputs . 17 201.13 HAZAR
39、DOUS SITUATIONS and fault conditions 27 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 28 201.15 Construction of ME EQUIPMENT 28 201.16 * ME SYSTEMS . 29 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 30 202 Electromagnetic compatibility Requirements and tests 30 208 Gene
40、ral requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems . 30 210 Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 32 211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used
41、in the HOME HEALTHCARE ENVIRONMENT . 32 Annexes 32 Annex G (normative) Protection against HAZARDS of ignition of flammable anesthetic mixtures 33 Annex AA (informative) Particular guidance and rationale. 34 Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and HAZARDOUS SI
42、TUATIONS in HEMODIALYSIS EQUIPMENT . 54 Bibliography 62 Index of defined terms used in this particular standard 63 Figure AA.1 Example of the HEMODIALYSIS ME SYSTEM . 49 Table 201.101 ESSENTIAL PERFORMANCE requirements . 7 Table AA.1: Possible ALARM CONDITION priorities according to 6.1.2 of IEC 606
43、01-1-8:2006, . 52 Table BB.1 Hazardous situation list following ISO 14971:2007, Annex E 54 Figure 201.101 Continuous air infusion test set-up with example dimensions . 24 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-16:2012 v Glossary of equivalent standards
44、International Standards adopted in the United States may include normative 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 Sta
45、ndard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without c
46、hange in 2009. Other normatively 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 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical
47、 variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrigendum 1 any IEC National Committee interested in the subject dealt with may participate in this preparatory work.
48、 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) T
49、he formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any m
