1、 IEC 80601-2-35Edition 2.0 2009-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical 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 Appareils lectromd
2、icaux Partie 2-35: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destins au rchauffage des patients en usage mdical IEC80601-2-35:2009 colourinsideTHIS PUBLICATION IS C
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17、: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 80601-2-35Edition 2.0 2009-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattres
18、ses and intended for heating in medical use Appareils lectromdicaux Partie 2-35: Exigences particulires pour la scurit de base et les performances essentielles des dispositifs de rchauffage utilisant des couvertures, des coussins ou des matelas chauffants et destins au rchauffage des patients en usa
19、ge mdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XBICS 11.140 PRICE CODECODE PRIXISBN 2-8318-1065-7colourinside 2 80601-2-35 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references10 201.3 Terms
20、 and definitions10 201.4 General requirements .13 201.5 General requirements for testing ME EQUIPMENT 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS14 201.7 ME EQUIPMENT identification, marking and documents .14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .17 201.9 Protecti
21、on against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .22 201.10 Protection against unwanted and excessive radiation HAZARDS .24 201.11 Protection against excessive temperatures and other HAZARDS .24 201.12 Accuracy of controls and instruments and protection against hazardous outputs .27 201.
22、13 HAZARDOUS SITUATIONS and fault conditions 32 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 37 201.15 Construction of ME EQUIPMENT.37 201.16 ME SYSTEMS 41 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .41 202 Electromagnetic compatibility Requirements and tests .42 20
23、8 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.42 210 * Requirements for the development of physiologic closed-loop controllers .42 Annex D (informative) Symbols on marking43 Annex AA (informative) Particular guidance and r
24、ationale44 Annex BB (normative) Determination of the LAGGING MATERIAL .55 Annex CC (normative) *Determination of heat transfer towards the PATIENT .56 Annex DD (normative) *Determination of heat transfer away from the PATIENT .58 Annex EE (normative) Conditions of adequate heat discharge .59 Annex F
25、F (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES60 Annex GG (normative) Test procedure for maximum CONTACT SURFACE TEMPERATURE for FORCED AIR DEVICES under SINGLE FAULT CONDITION.62 Annex HH (normative) Safety test procedure for average CONTACT SURFACE TEMP
26、ERATURE for FORCED AIR DEVICES63 Bibliography65 Index of defined terms used in this particular standard66 Figure 201.101 Positioning of temperature sensors on the contact surface of the heated area of a HEATING DEVICE (see 201.12.4.101 and 201.12.4.105).11 Figure 201.102 Example of the positioning o
27、f temperature sensors on the contact surface of the heated areas of a HEATING DEVICE having more than one separately heated area 11 80601-2-35 IEC:2009 3 Figure 201.103 a) Apparatus for the spark ignition test Detail A: The apparatus (see 201.8.8.4.101).19 Figure 201.103 b) Apparatus for the spark i
28、gnition test Detail B: Lower member of mask.20 Figure 201.103 c) Apparatus for the spark ignition test Detail C: Upper member of mask.20 Figure 201.103 Apparatus for the spark ignition test 20 Figure 201.104 Ramp for the impact test on PADS 23 Figure 201.105 Partial covering conditions.25 Figure 201
29、.106 Method of folding BLANKETS .34 Figure 201.107 Examples of folds 36 Figure 201.108 Positions of a BLANKET for the RUCK-RESISTANCE test41 Figure HH.1 Sensor locations Average CONTACT SURFACE TEMPERATURE64 Table 201.101 *Additional ESSENTIAL PERFORMANCE requirements 13 Table 201.102 Temperature li
30、mits in dependency to time.38 4 80601-2-35 IEC: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 intended for heating in medical use
31、 FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in th
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41、lity 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. International Standard IEC 80601-2-35 has been prepared by IEC technical committee 62D: Electromedical equipment, of IEC techni
42、cal committee 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 constitute
43、s a technical 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. 80601-2-35 IEC:2009 5 The text of this particular standard is based on the
44、following documents: FDIS Report on voting 62D/784A/FDIS 62D/804/RVD Full 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, the standard has been approved by 15 P-members out of 15 having cast a vote. Thi
45、s 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. Informative material appearing outside of tables, such as notes, examples and references
46、: 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 AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within th
47、e 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 all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed
48、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 is true. The verbal forms used in this standard conform to usage describe
49、d 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 compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to ach
