EN 50637-2017 en Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children.pdf

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1、Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for childrenBS EN 50637:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50637 November 2017

2、ICS 11.140 English Version Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children Appareils lectromdicaux - Exigences particulires de scurit de base et de performances essentielles des lits mdicaux pour enfants Medizinische

3、elektrische Gerte - Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von medizinischen Betten fr Kinder This European Standard was approved by CENELEC on 2017-08-30. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate

4、 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 CEN-CENELEC Management Centre or to any CENELEC member. This European St

5、andard 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 CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members a

6、re the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway,

7、Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Av

8、enue Marnix 17, B-1000 Brussels 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 50637:2017 ENational forewordThis British Standard is the UK implementation of EN 50637:2017.The UK participation in its preparation was entrusted

9、to Technical Committee 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 B

10、ritish Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 87946 3ICS 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 30 Novem

11、ber 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 50637:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50637 November 2017 ICS 11.140 English Version Medical electrical equipment - Particular requirements for the basic safety and essential perfo

12、rmance of medical beds for children Appareils lectromdicaux - Exigences particulires de scurit de base et de performances essentielles des lits mdicaux pour enfants Medizinische elektrische Gerte - Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von medizini

13、schen Betten fr Kinder This European Standard was approved by CENELEC on 2017-08-30. 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 list

14、s and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre 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 un

15、der the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre 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

16、stonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European

17、 Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide fo

18、r CENELEC Members. Ref. No. EN 50637:2017 EBS EN 50637:2017EN 50637:2017 (E) 2 Contents Page European foreword 5 Introduction 6 201.1 Scope, object and related standards 7 201.1.1 * Scope 7 201.1.2 Object 7 201.1.3 Collateral standards 7 201.1.4 Particular standards 8 201.2 Normative references . 8

19、201.3 Terms and definitions 9 201.4 General requirements . 14 201.4.2 *Risk management process for ME EQUIPMENT and ME SYSTEM . 14 201.5 General requirements for testing of ME EQUIPMENT 14 201.5.101 * Entrapment test TOOLS 14 201.5.102 Loading pad 17 201.5.103 Impactor 18 201.5.104 Side impactor . 1

20、9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 19 201.6.2 *Protection against electrical shock 19 201.7 ME EQUIPMENT identification, marking and documents 19 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 28 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME S

21、YSTEMS 28 201.9.1 *Mechanical HAZARDS of ME EQUIPMENT . 29 201.9.2 HAZARDS associated with moving parts . 36 201.9.3 HAZARDS associated with surfaces, corners and edges . 40 201.9.8 HAZARDS associated with support systems 45 201.9.101 *Protection against inadvertent PATIENT falls 54 201.10 Protectio

22、n against unwanted and excessive radiation HAZARDS 56 201.11 Protection against excessive temperatures and other HAZARDS 56 201.11.7 Biocompatibility of MEDICAL BED . 59 201.11.8 *Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT . 59 201.12 Accuracy of controls and instruments and prote

23、ction against hazardous outputs 59 201.12.2 USABILITY . 59 201.13 HAZARDOUS SITUATIONS and fault conditions . 59 201.14 Programmable electrical medical systems (PEMS) 60 201.15 Construction of ME EQUIPMENT 60 201.15.3 Mechanical strength 60 201.15.4 ME EQUIPMENT components and general assembly . 61

24、201.16 ME SYSTEMS 63 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 63 (normative) Particular guidance and rationale . 64 AA.1 General guidance 64 AA.1.1 Rationale for particular clauses and subclauses . 64 (normative) Design requirements and recommendations for MEDICAL BED 77

25、 BB.1 General . 77 BB.2 Human factors (ergonomic) . 77 BB.2.1 General 77 BB.2.2 Range of adjustment of the height of the mattress support platform 77 BB.2.3 Dimensions for handles and pedals 78 BB.2.4 Operating forces for handles and pedals 78 BB.3 Functionality 78 BB.3.1 General 78 BB.3.2 Combinati

26、on of MEDICAL BED and MOBILE hoists 78 BS EN 50637:2017EN 50637:2017 (E) 3 BB.3.3 Combination of MEDICAL BED and mattress. 79 BB.3.4 Range of adjustment of moveable sections of the MATTRESS SUPPORT PLATFORM . 79 (informative) Particular guidance for assessing risk of entrapment in v-shaped openings

27、. 81 Bibliography 87 FIGURE 201.101 MEDICAL BED, GENERAL ARRANGEMENT (EXAMPLE, SCHEMATIC PRESENTATION ONLY) 13 FIGURE 201.102A CONE TOOL . 15 FIGURE 201.102B FINGER PROBE FOR MESH . 15 FIGURE 201.102C CYLINDER TOOL . 15 FIGURE 201.102D BALL CHAIN . 16 FIGURE 201.102E BALL CHAIN LOOP AND SPHERICAL MA

28、SS . 16 FIGURE 201.102 ENTRAPMENT TEST TOOLS 16 FIGURE 201.103 LOADING PAD . 17 FIGURE 201.104 IMPACTOR . 18 FIGURE 201.105 - SIDE IMPACTOR 19 FIGURE 201.106 GRAPHICAL SYMBOL FOR MAXIMUM PATIENT WEIGHT AND SAFE WORKING LOAD . 20 FIGURE 201.107 MARKING FOR COMPATIBLE MATTRESSES SPECIFIED BY THE MANUF

29、ACTURER . 21 FIGURE 201.108 MARKING FOR DETACHABLE SIDE RAILS SPECIFIED BY THE MANUFACTURER . 21 FIGURE 201.109 DESCRIPTION OF ALLOWED LENGTH OF PATIENT 22 FIGURE 201.110 EXAMPLE OF MARKING ON THE MEDICAL BED FOR POSITIONING PATIENT IN MEDICAL BED . 23 FIGURE 201.111 MEDICAL BED FUNCTION CONTROLS AN

30、D/OR ACTUATORS: GUIDELINES FOR CREATING GRAPHICAL SYMBOLS . 25 FIGURE 201.112 MARKING ON THE MEDICAL BED OF STORAGE LOCATION FOR PENDANT CONTROL . 26 FIGURE 201.113 EXAMPLE OF MEDICAL BED WITH SEGMENTED OR SPLIT SIDE RAIL 30 FIGURE 201.114 EXAMPLE OF MEDICAL BED WITH SINGLE PIECE SIDE RAIL AND PROTE

31、CTION SIDE RAIL 31 FIGURE 201.115 - DIMENSION OF HANDLE FOR LIFTING POLE. . 35 FIGURE 201.116 ALLOWABLE SPACING FOR FINGERS IN AREAS OF NORMAL REACH AROUND THE PERIMETER OF THE MATTRESS SUPPORT PLATFORM 37 FIGURE 201.117 EXAMPLE USING BARRIERS FOR CLEARANCE MEASUREMENT AROUND THE PERIMETER OF THE MA

32、TTRESS SUPPORT PLATFORM TO MITIGATE PATIENT-FINGER ENTRAPMENT 38 FIGURE 201.118A FOOT AND TOE CLEARANCE AREA BETWEEN MOVING PARTS AND THE FLOOR 38 FIGURE 201.118B) TOE CLEARANCE AREA BETWEEN MOVING PARTS AND THE FLOOR . 39 FIGURE 201.118 CLEARANCE AREAS 39 FIGURE 201.119 - REQUIRED MINIMUM RADII OF

33、EDGES AND CORNERS . 40 FIGURE 201.120 RETENTION OF LOOP AND MASS . 41 FIGURE 201.121 LATERAL STABILITY TEST ALONG THE SIDE OF THE MEDICAL BED 42 FIGURE 201.122 LONGITUDINAL STABILITY TEST WITH REMOVABLE FOOT BOARD . 43 FIGURE 201.123 LONGITUDINAL STABILITY TEST WITH FIXED HEAD/FOOT BOARDS 43 FIGURE

34、201.124 DISTRIBUTION OF SAFE WORKING LOAD FOR TESTS 47 FIGURE 201.125 POSITION OF LOADING PAD AND IMPACTOR . 49 FIGURE 201.126 - IMPACT TO SLATS AND SOLID ELEMENTS OF MEDICAL BEDS 51 FIGURE 201.127 APPLICATION OF FORCES FOR TEST OF SIDE RAIL . 53 FIGURE 201.128 HEIGHT OF SIDE RAIL / PROTECTION SIDE

35、RAIL 55 FIGURE 201.129A ANGLE BETWEEN THE BACK SECTION AND THE LEG SECTION OF THE MATTRESS SUPPORT PLATFORM 61 FIGURE 201.129B ANGLE BETWEEN THE BACK SECTION AND THE UPPER LEG SECTION OF THE MATTRESS SUPPORT PLATFORM 61 FIGURE 201.129C ANGLE BETWEEN THE ANGLED BACK SECTION AND UPPER LEG SECTION OF T

36、HE MATTRESS SUPPORT PLATFORM 62 FIGURE 201.129D ANGLE BETWEEN THE ANGLED BACK SECTION AND THE LEG/UPPER LEG SECTION OF THE MATTRESS SUPPORT PLATFORM 62 FIGURE 201.129 CONFIGURATIONS OF THE MATTRESS SUPPORT PLATFORM . 62 FIGURE AA.1 RESULTANT FORCES WITHOUT MATTRESS . 68 FIGURE AA.2 RESULTANT FORCES

37、WITH MATTRESS 68 BS EN 50637:2017EN 50637:2017 (E) 4 FIGURE AA.3 EXAMPLE OF 40 MM GAP MEASUREMENT OF B . 68 FIGURE AA.4 ANGLE MEASUREMENT EXAMPLE OF B . 68 FIGURE AA.5 PLACEMENT OF MEASUREMENT TOOL FOR MEASUREMENT OF DX. 69 FIGURE AA.6 EXAMPLE OF AREA DXMEASUREMENT THAT PASSES . 70 FIGURE AA.7 EXAMP

38、LE OF AREA DXMEASUREMENT THAT FAILS 70 FIGURE AA.8 EXAMPLE OF AREA DXMEASUREMENT THAT FAILS (ON LIMIT) 70 FIGURE AA.9 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA A WITHIN THE SIDE RAIL 71 FIGURE AA.10 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA A BELOW THE SIDE RAIL 71 FIGURE AA.11 EXAMPLE O

39、F POTENTIAL PATIENT ENTRAPMENT IN AREA B . 71 FIGURE AA.12 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA C BETWEEN SPLIT SIDE RAIL 71 FIGURE AA.13 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA C BETWEEN SIDE RAIL AND HEAD BOARD . 71 FIGURE AA.14 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA DX

40、 . 71 FIGURE AA.15 EXAMPLE OF POTENTIAL PATIENT ENTRAPMENT IN AREA A BELOW A SINGLE PIECE SIDE RAIL . 72 FIGURE BB.1 SCHEMATIC PRESENTATION OF UNDER MEDICAL BED CLEARANCE 79 FIGURE BB.2 RECOMMENDATIONS AND REQUIREMENTS REGARDING ANGLES FOR DIFFERENT SECTIONS OF THE MATTRESS SUPPORT PLATFORM 80 FIGUR

41、E CC.1 WEDGE TOOL 82 FIGURE CC.2 V-SHAPED OPENING IN RELATION TO B . 83 FIGURE CC.3 PASS/FAIL IN RELATION TO AREA B 83 FIGURE CC.4 POSITIONING OF WEDGE TOOL 84 FIGURE CC.5 PASS/FAIL IN RELATION TO AREA C BETWEEN HEAD BOARD AND FOOT BOARD 85 FIGURE CC.6 PASS/FAIL IN RELATION TO AREA C BETWEEN SPLIT S

42、IDE RAILS 86 *TABLE 201.101 PROTECTION AGAINST PATIENT ENTRAPMENT 32 TABLE 201.102 PROTECTION AGAINST INADVERTENT PATIENT FALLS AND CLIMBING OUT OF MEDICAL BED . 56 TABLE 24 ALLOWABLE MAXIMUM TEMPERATURES FOR SKIN CONTACT WITH MEDICAL BED APPLIED PARTS . 57 TABLE AA.1 PROTECTION AGAINST PATIENT ENTR

43、APMENT IN NON-MOVING PARTS . 67 TABLE AA.2 HEIGHT OF PROTECTIVE BARRIER ACCORDING TO AGE . 75 BS EN 50637:2017EN 50637:2017 (E) 5 European foreword This document (EN 50637:2017) has been prepared by CLC/TC 62 ”Electrical equipment in medical practice“. The following dates are fixed: latest date by w

44、hich this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2018-08-30 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2020-08-30 Attention is drawn to the possibility that s

45、ome of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN and CENELEC by the European Commission. BS EN 50637:2017EN 50637:2017 (E) 6 Intr

46、oduction EN 60601-2-52 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS for ADULTS, hence not covering requirement for beds for CHILDREN and ADULTS with atypical anatomy. This particular standard is based on the Mandate M/467 Medical beds issued by the European Commision with th

47、e following background information: It appears, from a first analysis undertaken by Competent Authorities, that the current set of standards is not adapted to the needs of CHILDREN or ADULTS with an atypical anatomy. EN 60601-2-52 does not foresee a maximum distance for the bars that is small enough

48、 to prevent accidents. According to the Competent Authorities representatives, a part of the safety problem is due to the fact that medical beds for ADULTS are not appropriately labelled as being designed only for ADULTS with a normal anatomy. Users are therefore not always aware of the risk of medi

49、cal beds for young PATIENTS or for ADULTS with an atypical anatomy. Hospital administrations do not always see a need to buy medical beds which are appropriate for CHILDREN or for ADULTS with an atypical anatomy. Therefore, clear labelling of the targeted PATIENT groups for medical beds complying with EN 60601-2-52 could reduce the risk of inappropriate use of this kind of medical beds for CHILDREN or for ADULTS with an aty