1、ANSI/AAMI/IEC 60601-1-8:2006 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 est
2、ablishing 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 that
3、 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 a
4、 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 i
5、ndustrial 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 determ
6、ining 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 pro
7、curement 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 practice
9、 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-making
10、. 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 ration
11、ale 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 practice
12、s. 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 particula
13、r 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 contex
14、t 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 whe
15、n 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 w
18、hich 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 60601-1-8:2006 Fax: 703-525-1067. Printed in the United States of America ISBN 15
19、7020517-5 CONTENTS Glossary of equivalent standards v Committee representation . vi Background of ANSI/AAMI adoption of IEC 60601-1-8:2006 any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organi
20、zations 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) The formal decisions or agreements of IEC on technical ma
21、tters 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 Natio
22、nal 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 misinterpretation by any end user. 4) In order to promote international uniformity, I
23、EC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itse
24、lf does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that t
25、hey have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature
26、 whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced p
27、ublications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. This consolid
28、ated version of IEC 60601-1-8 consists of the second edition (2006) documents 62A/519/CDV and 62A/537A/RVC and its amendment 1 (2012) documents 62A/824/FDIS and 62A/837/RVD. It bears the edition number 2.1. The technical content is therefore identical to the base edition and its amendment and has be
29、en prepared for user convenience. A vertical line in the margin shows where the base publication has been modified by amendment 1. Additions and deletions are displayed in red, with deletions being struck through. x 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-
30、1-8:2006 or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. ALARM SYSTEMS). In this collateral standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. In addition, in An
31、nex A, text in italics indicates guidance that describes means to achieve the safety objectives of this collateral standard. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN
32、 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6
33、.1, 6.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.3.1 are all subclauses of Clause 6). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only.
34、 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary v
35、erb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-1-8:2006 “may” is used to describe a permissible way to achieve compliance with a requirement or test. C
36、lauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). A list of all parts of the IEC 60601 series, under the general title: Medical electrical equipment, can be found on the IEC website. The committee has decided that the content
37、s of the base publication and its amendments will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or ame
38、nded. NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make products in accordance with the new requirements and t
39、o equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication. IMPORTANT The “color inside” logo on the cover page of this
40、 publication indicates that it contains colors that are considered to be useful for the correct understanding of its contents. Users should therefore print this publication using a color printer. xii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-1-8:2006 the par
41、ticular circumstances which initiate an ALARM CONDITION; the allocation of priorities to a particular ALARM CONDITION; or the means of generating ALARM SIGNALS. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1. When referring t
42、o IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: 2 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-1-8:2006 “this collateral standard“ designates IEC 60601-1-8 alone; “this standard“ designate
43、s the combination of the general standard and this collateral standard. 1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard. 2 Normative references The following referenced documents, in whole or in part, are
44、 normatively referenced in this document and are indispensable for the its application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60417, Graphical symbols for us
45、e on equipment. Available from: IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance Amendment 1:2012 IEC 60601-1-2:-2), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral
46、 Standard: Electromagnetic compatibility Requirements and tests IEC 60601-1-6:-3), Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability IEC 60651:19794), Sound level meters Amendment 1 (1993) Amendment 2 (2000) IEC 6167
47、2-1:2002, Electroacoustics Sound level meters Part 1: Specifications IEC 62366:2007, Medical devices Application of usability engineering to medical devices ISO 3744:1994 2010, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering met
48、hod in for an essentially free field over a reflecting plane 2) A second edition of IEC 60601-1-2 exists, published in 2004 under the title Medical electrical equipment Part 1-2: General requirements for safety Collateral Standard: Electromagnetic compatibility Requirements and tests. A third editio
49、n under the title given above is currently to be published. References to IEC 60601-1-2 in this standard refer to the new edition.3)A first edition of IEC 60601-1-6 exists, published in 2004 under the title Medical electrical equipment Part 1-6: General requirements for safety Collateral Standard: Usability. A second edition under the title given above is currently to be published. References to IEC 60601-1-6 in this standard refer to the new edition. 4) IEC 60651:1979 has been withdra
