EN 60601-2-52-2010 en Medical electrical equipment - Part 2-52 Particular requirements for basic safety and essential performance of medical beds (Incorporating Corrigendum April 2.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-52: Particular requirements for basic safety and essential performance of medical bedsBS EN 60601-2-52:2010Incorporating corrigenda September 2010 and April 2011BS EN 60601-2-52:2010+A1:2015Incorporating corrigenda September 2010 and April

2、2011BS EN 60601-2-52:2010+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 60601-2-52:2010+A1:2015, incorporating corrigendum April 2011. It is identical to IEC 60601-2-52:2009, incorporating amendment 1:2015 and corrigendum September 2010. It supersedes

3、BS EN 60601-2-52:2010 which will be withdrawn on 22 April 2018.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. Text altered by IEC corrigendum September 2010 is indicated in the text by .The start and finish of text introduced or altered by amendme

4、nt is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice,

5、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. The British

6、Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 82158 5ICS 11.140Compliance 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 May 2010.Am

7、endments/corrigenda issued since publicationDate Text affected31 September 2011 Implementation of IEC corrigendum September 2010 and CENELEC corrigendum April 2011: modification of EN foreword30 June 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015EUROPEAN STANDARD EN 606

8、01-2-52NORME EUROPENNE EUROPISCHE NORMApril 2010CEN-CENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2010 CEN-CENELEC - All rights of ex

9、ploitation in any form and by any means reserved worldwide for CEN-CENELECmembers.Ref. No. EN 60601-2-52:2010 EICS 11.140 Incorporating corrigendum April 2011English versionMedical electricalequipment - Part 2-52: Particular requirements for basic safety and essentialperformance of medical beds (IEC

10、 60601-2-52:2009)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 Leistungsmerkm

11、ale von medizinischen Betten(IEC 60601-2-52:2009)This European Standard was approved by CENELEC on 2010-04-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any a

12、lteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by

13、translation under the responsibility of a CENELEC member into its own language and notifiedto 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,

14、 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.Supersedes EN 60601-2-38:1996 + A1:2000,EN 1970:2000EN 60601-2-5

15、2:2010+A1May 2015Foreword The text of document 62D/795/FDIS, future edition 1 of IEC 60601-2-52, prepared bySC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 60601-2-52 on 2010-04-0

16、1.This European Standard supersedes EN 60601-2-38:1996 + A1:2000 and EN 1970:2000.Attention is drawn to the possibilitythat some of the elements of this document may be the subject ofpatent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patentrights.The followi

17、ng dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2011-01-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2013-04-01This European Standardha

18、s been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements ofEC Directive 93/42/EEC. See Annex ZZ.Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe text of the International Standard IEC 6060

19、1-2-52:2009 wasapproved 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 Harmonized as EN 60601-2-38 _This European Standard is the result of a CENELEC lead joint c

20、ollaboration between CLC/TC 62 and CEN/TC 293. BS EN 60601-2-52:2010EN 60601-2-52:2010 (E) 2 BS EN 60601-2-52:2010+A1:2015EN 60601-2-52:2010+A1:2015 (E) 2 BS EN 60601-2-52:2010+A1:2015EN 60601-2-52:2010+A1:2015 (E) 3 EN 60601-2-52:2010/A1:2015 - 2 -ForewordThe text of document 62D/1186/FDIS, future

21、IEC 60601-2-52:2009/A1, prepared by SC 62D “Electromedical equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-52:2010/A1:2015. The following dates are fixed: latest date by which the document has to

22、beimplemented at national level bypublication of an identical nationalstandard or by endorsement(dop) 2016-01-22 latest date by which the nationalstandards conflicting with thedocument have to be withdrawn(dow) 2018-04-22 Attention is drawn to the possibility that some of the elements of this docume

23、nt may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirem

24、ents of EU Directive. For the relationship with EU Directive see informative Annex ZZ, included in EN 60601-2-52:2010. Endorsement notice The text of the International Standard IEC 60601-2-52:2009/A1:2015 was approved by CENELEC as a European Standard without any modification. Foreword to amendment

25、A1Annex ZA(normative)Normative references to international publicationswith their corresponding European publicationsThe following referenced documents are indispensable for the application of this document. For dated references, onlythe edition cited applies. For undated references, the latest edit

26、ion 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/HDapplies.Addition to Annex ZA of EN 60601-2:Publication Year Title EN/HD YearIEC 60068-2-31 2008 Environmental test

27、ing -Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-typespecimens EN 60068-2-31 2008BS EN 60601-2-52:2010EN 60601-2-52:2010 (E) 3 BS EN 60601-2-52:2010+A1:2015EN 60601-2-52:2010+A1:2015 (E) 4 Annex ZZ(informative)Coverage of Essential Requirements of EC Directives This Eu

28、ropean Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope thestandard covers all relevant essential requirements as given in Annex I of the EC Directive93/42/EEC except the following: Essential Requireme

29、nt 7.1Compliance with this standard provides one means of conformity with the specified essentialrequirements of the Directive concerned. WARNING:Other requirements and other EC Directives may be applicable to the productsfalling within the scope of this standard.BS EN 60601-2-52:2010EN 60601-2-52:2

30、010 (E) 4 BS EN 60601-2-52:2010+A1:2015EN 60601-2-52:2010+A1:2015 (E) 5 CONTENTSINTRODUCTION.201.1Scope, objectand related standards.201.2Normative references201.3Terms and definitions11201.4General requirements.14201.5General requirements for testingof ME EQUIPMENT 14201.6Classification of ME EQUIP

31、MENT and ME SYSTEMS16201.7MEEQUIPMENT identification, marking and documents.16201.8Protection againstelectrical HAZARDS from ME EQUIPMENT .21201.9Protection against MECHANICALHAZARDS of ME EQUIPMENT and ME SYSTEMS .22201.10 Protection against unwanted and excessive radiation HAZARDS .45201.11 Protec

32、tion againstexcessive temperatures and other HAZARDS .45201.12 Accuracy ofcontrols and instruments and protection againsthazardousoutputs.47201.13 HAZARDOUS SITUATIONS and fault conditions 48201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).48201.15 Construction of ME EQUIPMENT.49201.16 MESYSTEM

33、S52201.17 Electromagnetic compatibilityof ME EQUIPMENT and ME SYSTEMS.52Annexes.52AnnexAA (informative)Particular guidance and rationale53AnnexBB (normative) Design requirements and recommendations for MEDICAL BEDS.68AnnexCC (informative) Particular guidance forassessing risk of entrapment in v-shap

34、ed openings 76Bibliography82Indexof defined terms used in thisparticular standard83Figure 201.101 APPLIED PART11Figure 201.102 MEDICAL BED,general arrangement (example, schematic presentationonly).13Figure 201.103a Cone tool.15Figure 201.103b Cylindertool15Figure 201.103 Entrapment test tools.15Figu

35、re 201.104 Loading pad16Figure 201.105 Graphic symbol for maximum PATIENT weight and SAFE WORKINGLOAD .17Figure 201.106 MEDICAL BED function controls and/or actuators: guidelines forcreating graphic symbols19Figure 201.107 Example of MEDICAL BED withsegmented orsplit SIDE RAIL.23Figure 201.108 Examp

36、le of MEDICALBED with single piece SIDE RAIL.24Figure 201.109 Allowable spacing for fingersin areas of normal reach around theperimeter of the MATTRESS SUPPORT PLATFORM29BS EN 60601-2-52:2010EN 60601-2-52:2010 (E) 5 8910CONTENTSINTRODUCTION.201.1Scope, objectand related standards.2Normative referenc

37、es3Terms and definitions. 114General requirements. 45G s for testingof ME EQUIPMENT 6Classification of ME EQUIPMENT and SYSTEMS 67MEEQUIPMENT identification, marking and documents.8Protection againstelectrical HAZARDS from ME EQUIPMENT .219P MECHANICALHAZARDS of UIPM and ME SYSTEMS 210 Protection ag

38、ainst unwanted and excessive radiation HAZARDS 4511 tion gainstexcessive temperatures and other RDS12 Accuracy ofcontrols and instruments and protection againsthazardousoutputs.47201.13 HAZARDOUS SITUATIONS and fault conditions . 814 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)15 Construction of M

39、E EQUIPMENT. 916 MESYSTEMS. 5217 Electromagnetic compatibilityof ME EQUIPMENT and ME SYSTEMSAnnexesxAA (informative)Particular guidance and rationale 3xBB (normative) Design requirements recommendations for MEDICAL BEDS.68xCC (informative) Particular guidance forassessing risk of entrapment in v-sha

40、ped openings 76Bibliography82Indexof defined terms used in thisparticular standard 3Figure 201.101 APPLIED PART112 MEDICAL BED,general arrangement (example, schematic presentationonly).13Figure 201 103a Cone tool 5b Cylindertool201 Entrapment test tools.re 201.104 Loading pad 6Fi re 5 Graphic symbol

41、 for maximum PATIENT weight and SAFE WORKINGLOAD .17Figure 201.106 MEDICAL BED function controls and/or actuators: guidelines forcreating graphic symbols19Figure 201.107 Example of MEDICAL BED withsegmented orsplit SIDE RAIL 2308 DICALBED ith single piece SIDE RAIL 409 Allowable spacing for fingersi

42、n areas of normal reach around theperimeter of the MATTRESS SUPPORT PLATFORM29BS EN 60601-2-52:2010EN 60601-2-52:2010 (E) 5 8910BS EN 60601-2-52:2010+A1:2015EN 60601-2-52:2010+A1:2015 (E) 6 91012121616181823244747495050515454545570788485121417171821252631Figure 201.120 Physical description of an adu

43、lt .19Figure 201.103a Cool tool schematic .Figure 201.103b Cylinder tool schematic .1617 Figure 201.110 Example using barriers for clearance measurement around theperimeter of the MATTRESS SUPPORT PLATFORMto mitigate PATIENT-finger entrapmentFigure 201.111a Foot and toe clearance area between moving

44、 partsand the floor.Figure 201.111b Toe clearancearea between moving parts and the floor31Figure 201.111 Clearance areas31Figure 201.112 Lateral stability test along the side of the MEDICAL BED.33Figure 201.113 Longitudinal stabilitytest with removable FOOT BOARD .33Figure 201.114 Longitudinal stabi

45、litytest with fixed HEAD/FOOT BOARDS34Figure 201.115 Distribution of SAFE WORKINGLOAD for tests38Figure 201.116 Position of loading pad (see Figure 201.104).41Figure 201.117 Application of forces fortestof SIDE RAIL43Figure 201.118 Height of SIDE RAIL.44Figure 201.119a Angle between the back section

46、 and the leg section of theMATTRESS SUPPORT PLATFORMFigure 201.119b Angle between the back section and the upper leg section oftheMATTRESS SUPPORT PLATFORMFigure 201.119c Angle between the angled backsection and upper leg section ofthe MATTRESS SUPPORT PLATFORMFigure 201.119d Angle between the angle

47、d backsection and the leg/upper leg section of the MATTRESS SUPPORT PLATFORM51Figure 201.119 Configurations of the MATTRESS SUPPORT PLATFORM.51Figure AA.1 Marking to select recommended mattresses specified bytheMANUFACTURER55Figure AA.2 Marking for detachable SIDE RAILS specified by the MANUFACTURER

48、 .55Figure AA.3 Resultantforces withoutmattress.59Figure AA.4 Resultantforces with mattress59Figure AA.5 Example of 60 mm gap measurement of B59Figure AA.6 Anglemeasurement example of B59Figure AA.7 Placement of measurement TOOL for measurement of D.60Figure AA.8 Example of area Dmeasurement that pa

49、sses.60Figure AA.9 Example of area Dmeasurement that fails60Figure AA.10 Example of area D measurement that fails (on limit).61Figure AA.11 Example ofpotential PATIENT entrapment in area A within the SIDE RAIL61Figure AA.12 Example ofpotential PATIENT entrapment in area A below the SIDE RAIL61Figure AA.13 Example ofpotential PATIENT entrapmentin area B.61Figure AA.14 Example ofpotential PATIENT entrapment in a