1、ANSI/AAMI/ISO 80601-2-35:2009Medical electrical equipmentPart 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use American National StandardThis document was approved and published
2、when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained, so there are some variations from the typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA
3、 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, wi
4、thout 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 permission of the
5、 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.org or contact AA
6、MI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. Printed in the United States of America ISBN 1570205361 Approved as an American National Standard by ASTM InternationalINTERNATIONAL ANSI/IECSTANDARD 80601-2-35Edition 2.0 2009-10Medical electrica
7、l equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical useAppareils lectromdicaux- Partie 2-35: Exigences particulires pour la scurit de base et les performances essentiel
8、les des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destins au rchauffage des patients en usage mdical ASTM InternationalApproved as an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009-10These materials are subject to copyrig
9、ht claims of ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International. Ii ASTM InternationalApproved a
10、s an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009 CONTENTSFOREWORDvINTRODUCTION viii201.1 Scope, object and related standards . 1201.2 Normative references . 3201.3 Terms and definitions . 3201.4 General requirements. 6201.5 General requirements for testing ME EQUIPMENT 7
11、201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7201.7 ME EQUIPMENT identification, marking and documents 7201.8 Protection against electrical HAZARDS from ME EQUIPMENT .11201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .16201.10 Protection against unwanted and exces
12、sive radiation HAZARDS .18201.11 Protection against excessive temperatures and other HAZARDS .18201.12 Accuracy of controls and instruments and protection against hazardous outputs21201.13 HAZARDOUS SITUATIONS and fault conditions26201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)31201.15 Constr
13、uction of ME EQUIPMENT31201.16 ME SYSTEMS 36201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .36202 Electromagnetic compatibility Requirements and tests 36208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICALELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS 3
14、6210 * Requirements for the development of physiologic closed-loop controllers .37Annex D (informative) Symbols on marking.37Annex AA (informative) Particular guidance and rationale .38Annex BB (normative) Determination of the LAGGING MATERIAL 50Annex CC (normative) *Determination of heat transfer t
15、owards the PATIENT .51Annex DD (normative) *Determination of heat transfer away from the PATIENT .53Annex EE (normative) Conditions of adequate heat discharge.54Annex FF (normative) Test procedure for maximum CONTACT SURFACE TEMPERATUREfor FORCED AIR DEVICES 55Annex GG (normative) Test procedure for
16、 maximum CONTACT SURFACE TEMPERATUREfor FORCED AIR DEVICES under SINGLE FAULT CONDITION57Annex HH (normative) Safety test procedure for average CONTACT SURFACETEMPERATURE for FORCED AIR DEVICES 58Bibliography60Index of defined terms used in this particular standard.61Figure 201.101 Positioning of te
17、mperature sensors on the contact surface of the heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105) 12 ASTM International iii Approved as an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009 Figure 201.102 Example of the positioning of temperature sensors on th
18、e contact surface of the heated areas of a HEATING DEVICE having more than one separately heated area 5Figure 201.103 a) Apparatus for the spark ignition test Detail A: The apparatus (see 201.8.8.4.101).13Figure 201.103 b) Apparatus for the spark ignition test Detail B: Lower member of mask 14Figure
19、 201.103 c) Apparatus for the spark ignition test Detail C: Upper member of mask 14Figure 201.103 Apparatus for the spark ignition test .14Figure 201.104 Ramp for the impact test on PADS .17Figure 201.105 Partial covering conditions .19Figure 201.106 Method of folding BLANKETS 28Figure 201.107 Examp
20、les of folds.30Figure 201.108 Positions of a BLANKET for the RUCK-RESISTANCE test .35Figure HH.1 Sensor locations Average CONTACT SURFACE TEMPERATURE .59Table 201.101 *Additional ESSENTIAL PERFORMANCE requirements 7Table 201.102 Temperature limits in dependency to time 33iv ASTM InternationalApprove
21、d as an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _MEDICAL ELECTRICAL EQUIPMENT Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intende
22、d for heating in medical use FOREWORD1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Committees). The object of IEC is to promoteinternational co-operation on all questions concern
23、ing standardization in the electrical and electronic fields. Tothis end and in addition to other activities, IEC publishes International Standards, Technical Specifications,Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IECPublication(s)”). Their pre
24、paration is entrusted to technical committees; any IEC National Committee interestedin the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closelyw
25、ith the International Organization for Standardization (ISO) in accordance with conditions determined byagreement between the two organizations.2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an internationalconsensus of opinion on the relevant subje
26、cts since each technical committee has representation from allinterested IEC National Committees.3) IEC Publications have the form of recommendations for international use and are accepted by IEC NationalCommittees in that sense. While all reasonable efforts are made to ensure that the technical con
27、tent of IECPublications is accurate, IEC cannot be held responsible for the way in which they are used or for anymisinterpretation by any end user.4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publicationstransparently to the maximum extent possible
28、in their national and regional publications. Any divergencebetween any IEC Publication and the corresponding national or regional publication shall be clearly indicated inthe latter.5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformityasses
29、sment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for anyservices carried out by independent certification bodies.6) All users should ensure that they have the latest edition of this publication.7) No liability shall attach to IEC or its directors, employee
30、s, servants or agents including individual experts andmembers of its technical committees and IEC National Committees for any personal injury, property damage orother damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) andexpenses arising out of the publi
31、cation, use of, or reliance upon, this IEC Publication or any other IECPublications.8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications isindispensable for the correct application of this publication.9) Attention is drawn to the possibility
32、 that some of the elements of this IEC Publication may be the subject ofpatent rights. IEC shall not be held responsible for identifying any or all such patent rights.International Standard IEC 80601-2-35 has been prepared by IEC technical committee 62D: Electromedical equipment, of IEC technical co
33、mmittee 62: Electrical equipment in medical practice, and subcommittee 1: Breathing attachments and anaesthetic machines, of ISO technical committee 121: Anaesthetic and respiratory equipment. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a te
34、chnical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible. ASTM International vApproved as an American National Standard by ASTM Internation
35、alANSI/IEC 80601-2-35:2009 The text of this particular standard is based on the following documents: FDIS Report on voting 62D/784A/FDIS 62D/804/RVDFull information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. In ISO, t
36、he standard has been approved by 15 P-members out of 15 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informati
37、ve 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 CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR ASNOTED: SMALL CAPITALS.In referring to the structure of this standar
38、d, the term “clause” means one of the seventeen numbered divisions within the table of contents,inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are allsubclauses of Clause 7).References to
39、 clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions
40、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 verb: “shall” means that compliance with a requirement or a test is mandatory for compliancewith this standard; “should” means tha
41、t compliance with a requirement or a test is recommended but is notmandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement ortest.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table ti
42、tle indicates that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment can be found on the IEC website. vi ASTM InternationalApproved as an American National Standard by ASTM Int
43、ernationalANSI/IEC 80601-2-35:2009 The committee has decided that the contents of this particular standard will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publicatio
44、n will be reconfirmed; withdrawn; replaced by a revised edition, or amended.IMPORTANT The “colour inside” logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this p
45、ublication using a colour printer. ASTM International viiApproved as an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009 INTRODUCTIONThe minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operati
46、on for heating devices using BLANKETS,PADS or MATTRESSES and intended for heating in medical use. This particular standard amends and supplements IEC 60601-1 (third edition, 2005) Medical electrical equipment Part 1: General requirements for basic safety and essential performance, hereinafter referr
47、ed to as the general standard. The text of this particular standard relating to forced air warmers is based on ASTM F2196-02, Standard specification for circulating liquid and forced air patient temperature management devices.The requirements are followed by specifications for the relevant tests. A
48、“general guidance and rationale“ section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA. While K (degree Kelvin) is the recognized unit and symbol for absolute temperature and temperature difference, C has been used throughout this par
49、ticular standard because all measurements are commonly made using equipment marked with the Celsius temperature scale.viii ASTM InternationalApproved as an American National Standard by ASTM InternationalANSI/IEC 80601-2-35:2009 MEDICAL ELECTRICAL EQUIPMENT Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use 201.1 Scope, object and related standards Clause
