1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-52: Particular requirements for basic safety and essential performance of medical bedsBS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANG
2、E CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 60601-2-52:2010. It isidentical to IEC 60601-2-52:2009. It supersedes BS EN 1970:2000 and BS EN 60601-2-38:1997, which will be withdrawn on 1 April 2013.The UK partici
3、pation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/4,Electromedical equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to includ
4、e all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010ISBN 978 0 580 54190 2ICS 11.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and S
5、trategy Committee on 31 May 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 60601-2-52 NORME EUROPENNE EUROPISCHE NORM April
6、 2010 CEN-CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2010 CEN-CENELEC - All rights of exploitation in any form and by any mea
7、ns reserved worldwide for CEN-CENELEC members. Ref. No. EN 60601-2-52:2010 E ICS 11.140 Supersedes EN 60601-2-38:1996 + A1:2000, EN 1970:2000English version Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:20
8、09) Appareils lectromdicaux - Partie 2-52: Exigences particulires pour la scurit de base et les performances essentielles des lits mdicaux (CEI 60601-2-52:2009) Medizinische elektrische Gerte - Teil 2-52: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von m
9、edizinischen Betten (IEC 60601-2-52:2009) This European Standard was approved by CENELEC on 2010-04-01. 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 alterat
10、ion. 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 tran
11、slation 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, Croatia, Cyprus, the Czech Republic, Denmark, E
12、stonia, 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 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHIN
13、A STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSIEN 60601-2-52:2010 - 2 - Foreword The text of document 62D/795/FDIS, future edition 1 of IEC 60601-2-52, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC par
14、allel vote and was approved by CENELEC as EN 60601-2-52 on 2010-04-01. This European Standard supersedes EN 60601-2-38:1996 + A1:2000 and EN 1970:2000. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be h
15、eld responsible for identifying any or all such patent rights. 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) 2011-01-01 latest date by which the national standards conflicti
16、ng with the EN have to be withdrawn (dow) 2013-04-01 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 93/42/EEC. See Annex ZZ. Annexes ZA and ZZ have been add
17、ed by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-52:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standards indicated: IEC 60601-2-38 NOTE Harmo
18、nized as EN 60601-2-38 _ BS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSI- 3 - EN 60601-2-52:2010 Annex ZA (normative) Normative references to international publications with their corresponding European publications The followi
19、ng 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
20、common modifications, indicated by (mod), the relevant EN/HD applies. Addition to Annex ZA of EN 60601-2: Publication Year Title EN/HD Year IEC 60068-2-31 2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens EN 60068-2-31 2008 BS EN 6
21、0601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSIEN 60601-2-52:2010 - 4 - Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the Europe
22、an 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 except the following: Essential Requirement 7.1 Compliance with this standard provides one means of conformity with the
23、 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 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Co
24、py, (c) BSI 2 60601-2-52 IEC:2009 CONTENTS INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references9 201.3 Terms and definitions10 201.4 General requirements .13 201.5 General requirements for testing of ME EQUIPMENT 13 201.6 Classification of ME EQUIPMENT and ME SYSTEM
25、S15 201.7 ME EQUIPMENT identification, marking and documents .15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .20 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .21 201.10 Protection against unwanted and excessive radiation HAZARDS .44 201.11 Protection a
26、gainst excessive temperatures and other HAZARDS .44 201.12 Accuracy of controls and instruments and protection against hazardous outputs .46 201.13 HAZARDOUS SITUATIONS and fault conditions 47 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47 201.15 Construction of ME EQUIPMENT.48 201.16 ME S
27、YSTEMS 51 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .51 Annexes .51 Annex AA (informative) Particular guidance and rationale52 Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS.67 Annex CC (informative) Particular guidance for assessing risk of e
28、ntrapment in v-shaped openings 75 Bibliography81 Index of defined terms used in this particular standard82 Figure 201.101 APPLIED PART10 Figure 201.102 MEDICAL BED, general arrangement (example, schematic presentation only) .12 Figure 201.103a Cone tool.14 Figure 201.103b Cylinder tool 14 Figure 201
29、.103 Entrapment test tools.14 Figure 201.104 Loading pad 15 Figure 201.105 Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD .16 Figure 201.106 MEDICAL BED function controls and/or actuators: guidelines for creating graphic symbols 18 Figure 201.107 Example of MEDICAL BED with segmente
30、d or split SIDE RAIL .22 Figure 201.108 Example of MEDICAL BED with single piece SIDE RAIL .23 Figure 201.109 Allowable spacing for fingers in areas of normal reach around the perimeter of the MATTRESS SUPPORT PLATFORM 28 BS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30
31、/08/2010 07:59, Uncontrolled Copy, (c) BSI60601-2-52 IEC:2009 3 Figure 201.110 Example using barriers for clearance measurement around the perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment 29 Figure 201.111a Foot and toe clearance area between moving parts and the floo
32、r.29 Figure 201.111b Toe clearance area between moving parts and the floor 30 Figure 201.111 Clearance areas 30 Figure 201.112 Lateral stability test along the side of the MEDICAL BED.32 Figure 201.113 Longitudinal stability test with removable FOOT BOARD .32 Figure 201.114 Longitudinal stability te
33、st with fixed HEAD/FOOT BOARDS33 Figure 201.115 Distribution of SAFE WORKING LOAD for tests37 Figure 201.116 Position of loading pad (see Figure 201.104).40 Figure 201.117 Application of forces for test of SIDE RAIL42 Figure 201.118 Height of SIDE RAIL .43 Figure 201.119a Angle between the back sect
34、ion and the leg section of the MATTRESS SUPPORT PLATFORM49 Figure 201.119b Angle between the back section and the upper leg section of the MATTRESS SUPPORT PLATFORM49 Figure 201.119c Angle between the angled back section and upper leg section of the MATTRESS SUPPORT PLATFORM 49 Figure 201.119d Angle
35、 between the angled back section and the leg/upper leg section of the MATTRESS SUPPORT PLATFORM 50 Figure 201.119 Configurations of the MATTRESS SUPPORT PLATFORM .50 Figure AA.1 Marking to select recommended mattresses specified by the MANUFACTURER54 Figure AA.2 Marking for detachable SIDE RAILS spe
36、cified by the MANUFACTURER .54 Figure AA.3 Resultant forces without mattress.58 Figure AA.4 Resultant forces with mattress58 Figure AA.5 Example of 60 mm gap measurement of B58 Figure AA.6 Angle measurement example of B 58 Figure AA.7 Placement of measurement TOOL for measurement of D .59 Figure AA.
37、8 Example of area D measurement that passes .59 Figure AA.9 Example of area D measurement that fails59 Figure AA.10 Example of area D measurement that fails (on limit) .60 Figure AA.11 Example of potential PATIENT entrapment in area A within the SIDE RAIL 60 Figure AA.12 Example of potential PATIENT
38、 entrapment in area A below the SIDE RAIL 60 Figure AA.13 Example of potential PATIENT entrapment in area B.60 Figure AA.14 Example of potential PATIENT entrapment in area C between split SIDE RAIL 60 Figure AA.15 Example of potential PATIENT entrapment in area C between SIDE RAIL and HEAD BOARD 61
39、Figure AA.16 Example of potential PATIENT entrapment in area D.61 Figure AA.17 Example of potential PATIENT entrapment in area A below a single piece SIDE RAIL 61 Figure BB.1 Other areas of possible impact testing68 Figure BB.2 Impactor .69 Figure BB.3 Schematic presentation of under MEDICAL BED cle
40、arance.72 BS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSI 4 60601-2-52 IEC:2009 Figure BB.4 Recommendations and requirements regarding angles for different sections of the MATTRESS SUPPORT PLATFORM 74 Figure CC.1 Wedge tool.76
41、Figure CC.2 V-shaped opening in relation to B.77 Figure CC.3 Pass/fail in relation to area B .77 Figure CC.4 Positioning of wedge tool .78 Figure CC.5 Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD79 Figure CC.6 Pass/fail in relation to area C between split SIDE RAILS .80 Table 20
42、1.101 Protection against PATIENT entrapment .24 Table 201.102 Protection against inadvertent PATIENT falls 44 Table 24 Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED PARTS45 Table BB.1 Normative and informative requirements for different APPLICATION ENVIRONMENTS 1 to 5 .67
43、BS EN 60601-2-52:2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 30/08/2010 07:59, Uncontrolled Copy, (c) BSI60601-2-52 IEC:2009 7 INTRODUCTION In 1996, the IEC published the first edition of the particular standard for electrically operated hospital beds, IEC 60601-2-38. The publication
44、was in response to demand in the field for a universal standard addressing HAZARDS specific to the safety of the hospital bed. Used in conjunction with a MANUFACTURERS RISK ASSESSMENT, the standard was felt to be the current thinking on establishing a basic safety benchmark for industry. An amendmen
45、t of IEC 60601-2-38 issued in 1999 recognized the need to mitigate against a RISK of PATIENT entrapment in the SIDE RAILS, again combined with the use of the MANUFACTURERS RISK ASSESSMENT. Although this improved the particular standard, it still was centered upon electrically operated hospital beds,
46、 and failed to take into account manually operated hospital beds and products in other medical environments. In 2000, the EN 1970 standard (Adjustable beds for DISABLED PERSONS Requirements and test methods) was published, which addressed beds used by DISABLED PERSONS to alleviate or compensate for
47、a disability or handicap. This standard offered a broadened scope in conjunction with IEC 60601-2-38, but after the edition of Amendment 1 to IEC 60601-2-38, the opportunity presented itself to combine the two standards to a common, international standard. As work began on the integration, the IEC a
48、djusted its stance on BASIC SAFETY and ESSENTIAL PERFORMANCE, integrating them into the third edition of IEC 60601-1. It therefore became necessary to align the new standard with the third edition. The particular standard was given a new number, IEC 60601-2-52, and work began on alignment to third e
49、dition. This particular standard, therefore, is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. It represents the current thinking in BASIC SAFETY and ESSENTIAL PERFORMANCE of the MEDICAL BED as used to alleviate illness of PATIENTS and disability of DISABLED PERSONS. This is the effort of a join
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