1、 IEC 60601-2-57 Edition 1.0 2011-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic u
2、se Appareils lectromdicaux Partie 2-57: Exigences particulires pour la scurit de base et les performances essentielles des appareils source de lumire non-laser prvus pour des utilisations thrapeutiques, de diagnostic, de surveillance et de cosmtique/esthtique IEC60601-2-57:2011 colourinsideTHIS PUBL
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17、ntactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-2-57 Edition 1.0 2011-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment
18、 intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use Appareils lectromdicaux Partie 2-57: Exigences particulires pour la scurit de base et les performances essentielles des appareils source de lumire non-laser prvus pour des utilisations thrapeutiques, de diagnostic, de surve
19、illance et de cosmtique/esthtique INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.50; 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-88912-344-5 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotec
20、hnique Internationale colourinside 2 60601-2-57 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards 8 201.2 Normative references 10 201.3 Terms and definitions 10 201.4 General requirements 13 201.5 General requirements for testing ME EQUIPMENT . 13 201.6 Classi
21、fication of ME EQUIPMENT and ME SYSTEMS . 13 201.7 ME EQUIPMENT identification, marking and documents 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 19 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20 201.10 Protection against unwanted and excessive rad
22、iation HAZARDS 20 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21 201.13 HAZARDOUS SITUATIONS and fault conditions . 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Co
23、nstruction of ME EQUIPMENT . 23 201.16 ME SYSTEMS. 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 Annexes . 23 Annex AA (informative) Particular guidance and rationale 24 Annex BB (informative) Exposure limit values 26 Annex CC (informative) Protective eyewear for LS EQUIP
24、MENT 30 Annex DD (informative) Summary of MANUFACTURERS requirements 31 Annex EE (informative) Symbols on marking 32 Bibliography 33 Index of defined terms used in this particular standard 34 Figure 201.101 Example of explanatory label for a device with multiple HAZARD spectral regions 18 Figure 201
25、.102 Warning label HAZARD symbol . 19 Table 201.101 EMISSION LIMITS for risk groups of LS EQUIPMENT 14 Table 201.102 Risk group time base criteria for classification of LS EQUIPMENT 15 Table 201.103 Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT . 15 Table
26、 201.104 Requirements for labelling of LS EQUIPMENT according to risk group classification . 17 Table BB.1 EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26 Table BB.2 S() dimensionless, 200 nm to 400 nm 28 Table BB.3 B (), R () dimensionless, 300 nm to 1 400 nm . 29 60601-2-57 IEC:2011
27、3 Table DD.1 Summary of MANUFACTURERS requirements . 31 Table EE.1 Symbols, references and descriptions 32 4 60601-2-57 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-57: Particular requirements for the basic safety and essential performance of non-laser lig
28、ht source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of
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38、spensable 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. International Standard IEC 60601
39、-2-57 has been prepared by IEC technical committee TC 76: Optical radiation safety and laser equipment The text of this standard is based on the following documents: FDIS Report on voting 76/438/FDIS 76/441/RVD Full information on the voting for the approval of this standard can be found in the repo
40、rt on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: 60601-2-57 IEC:2011 5 Requirements and definitions: roman type. Test specifications: italic type. Informative material
41、 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 AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the t
42、erm “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 all subclauses of Clause 7). References to clau
43、ses 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 is tr
44、ue. 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 compliance with this standard; “should” means that co
45、mpliance 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 achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table tit
46、le 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. 6 60601-2-57 IEC:2011 The committee has decided that the contents of this p
47、ublication 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 amended. IMPORTANT The colour inside
48、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 document using a colour printer. 60601-2-57 IEC:2011 7 INTRODUCTION This particular standard amends and sup
49、plements IEC 60601-1:2005 (third edition): Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance. The requirements of this particular standard should be taken as the minimum to comply with, in order to achieve a reasonable level of safety and reliability during operation and application of non-laser light source equ
