BS EN 60601-2-50-2009 医用电气设备.婴儿光疗设备基本安全和基本性能的特殊要求.pdf

®¿·-·²¹ -¬¿²¼¿®¼- ©±®´¼©·¼» ÒÑ ÝÑÐÇ×ÒÙ É×ÌØÑËÌ ÞÍ× ÐÛÎÓ×ÍÍ×ÑÒ ÛÈÝÛÐÌ ßÍ ÐÛÎÓ×ÌÌÛÜ ÞÇ ÝÑÐÇÎ×ÙØÌ ÔßÉ ÞÍ× Þ®·¬·-¸ ͬ¿²¼¿®¼- ®¿·-·²¹ -¬¿²¼¿®¼- ©±®´¼©·¼» ÒÑ ÝÑÐÇ×ÒÙ É×ÌØÑËÌ ÞÍ× ÐÛÎÓ×ÍÍ×ÑÒ ÛÈÝÛÐÌ ßÍ ÐÛÎÓ×ÌÌÛÜ ÞÇ ÝÑÐÇÎ×ÙØÌ ÔßÉ ÞÍ× Þ®·¬·-¸ ͬ¿²¼¿®¼- Medical electrical equipment Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment BS EN 60601-2-50: 2009 National foreword This British Standard is the UK implementation of EN 60601-2-50:2009. It is identical to IEC 60601-2-50:2009. It supersedes BS EN 60601-2-50:2002, which will be withdrawn on 1 May 2012. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/4, Electromedical equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. © BSI 2009 ISBN 978 0 580 57241 8 ICS 11.040.60 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009 Amendments issued since publication Amd. No. Date Text affected BRITISH STANDARDBS EN 60601-2-50:2009 EUROPEAN STANDARD EN 60601-2-50 NORME EUROPÉENNE EUROPÄISCHE NORM May 2009 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels © 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-50:2009 E ICS 11.040.60 Supersedes EN 60601-2-50:2002 English version Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009) Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés (CEI 60601-2-50:2009) Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten (IEC 60601-2-50:2009) This European Standard was approved by CENELEC on 2009-05-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60601-2-50:2009 EN 60601-2-50:2009 - 2 - Foreword The text of document 62D/736A/FDIS, future edition 2 of IEC 60601-2-50, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-50 on 2009-05-01. This European Standard supersedes EN 60601-2-50:2002. Specific technical changes from EN 60601-2-50:2002 include: requiring graphical representation of the spectral irradiance in the instructions for use (this was previously optional; see 201.7.9.2.5 b); requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101); requiring restoration of any preset values upon interruption and restoration of the power supply, if applicable (see 201.11.8); and corrections to the first four exposure limits (ELs) listed in Table AA.1. Minor changes from EN 60601-2-50:2002 include replacing the figure containing the eye protection symbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see 201.3.202) and clarifying the titles for subclauses 201.5.4.102 and 201.5.4.103. The main purpose, however, is to provide consistency with the general standard EN 60601-1:2006. This EN 60601-2-50:2009 further provides consistency with the four other particular standards related to pediatric equipment for which the committee is responsible. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2010-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-05-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. 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: 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 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). BS EN 60601-2-50:2009 - 3 - EN 60601-2-50:2009 References to 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 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 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 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 title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-50:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60335-2-27 NOTE Harmonized as EN 60335-2-27:1997 (not modified). IEC 60601-2-19 NOTE Harmonized as EN 60601-2-19:2009 (not modified). IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified). ISO 3743-1 NOTE Harmonized as EN ISO 3743-1:1995 (not modified). _ BS EN 60601-2-50:2009 EN 60601-2-50:2009 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the 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. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 BS EN 60601-2-50:2009 - 5 - EN 60601-2-50:2009 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. _ BS EN 60601-2-50:2009 2 60601-2-50 IEC:2009 CONTENTS INTRODUCTION.6 201.1 Scope, object and related standards .7 201.2 Normative references9 201.3 Terms and definitions9 201.4 General requirements10 201.5 General requirements for testing of ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT identification, marking and documents11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS14 201.10 Protection against unwanted and excessive radiation HAZARDS15 201.11 Protection against excessive temperatures and other HAZARDS16 201.12 Accuracy of controls and instruments and protection against hazardous outputs16 201.13 HAZARDOUS SITUATIONS and fault conditions.19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19 201.15 Construction of ME EQUIPMENT.19 201.16 ME SYSTEMS20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.20 202 Electromagnetic compatibility .20 Annexes .20 Annex AA (informative) Particular guidance and rationale21 Bibliography26 Index of defined terms used in this particular standard28 Figure 201.101 Example of a measuring grid .17 Figure 201.102 Layout of weight test devices.19 Table 201.101 List of symbols, abbreviations and acronyms 10 Table AA.1 UV radiation exposure limits and spectral weighting function .24 BS EN 60601-2-50:2009 6 60601-2-50 IEC:2009 INTRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of INFANT PHOTOTHERAPY EQUIPMENT. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance, hereinafter referred to as the general standard. The requirements are followed by specifications for the relevant tests. A general guidance and rationale for the requirements of this particular standard are given in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of this particular standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard. BS EN 60601-2-50:2009 60601-2-50 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment 201.1 Scope, object and related standards Clause 1 of the general standard1) applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information see IEC 80601-2-35; INFANT INCUBATORS; for information see IEC 60601-2-19; INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; INFANT RADIANT WARMERS; for information see IEC 60601-2-21. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in 201.3.203), which reduce the safety HAZARDS to PATIENTS and OPERATORS as much as possible and to specify tests for demonstrating compliance with these requirements. 1) The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. BS EN 60601-2-50:2009 8 60601-2-50 IEC:2009 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard. IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-102) do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMA