Bsi bs en 01970 2000 scan

STD-BSI BS EN 1970-ENGL 2000 H L b b b 0865976 II BS EN L970:2000 BRITISH STANDARD Adjustable beds for disabled persons Requirements and test methods The European Stanàard EN 1970 British Standard as the status of a ICs 11.180, 97.140 NO COPYING WITEIOUT BSI PERMISSION EXCEPT AS PERMIWED BY COPYRIGIIT LAW COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 BS EN 19702000 National foreword This British Standard is the official English language version of E N 19702000 The UK participation in its preparation was entrusted by Technical Committee Cw31, Hospital furniture, to Subcommittee Cw31/1, Hospital bedsteads, which has the responsibility to: - aid enquirers to undeistand the text; - present to the responsible European committee any enquiries on the interpretation,or proposals for change, and keep the UK interests informed; - monitor related i n t e d o m l and European developments and promulgate them in the UK A list of organizationsrepresented on this subcommittee can be obtained on request to its secretary Cross-references The British Standards which implement intemational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”,or by using the “F”’ facility of the BSI Standards Electronic Catalogue A British Standard does not purport to include all the necessary provisions of a contract Users of British standardsare responsible for their correct application Compliance with a British Standard does not of itself confer immunity from legal obligations Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages to 41 and a back cover The BSI copyright notice displayed in this document indicates when the document was last issued This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15August Zoo0 Amendments issued since publication BSI û8-2ûûû ISBN O 680 36036 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services ~ STD.BS1 BS EN Lï70-ENGL 2000 H L b b b ï OBbsq78 m EN 1970 EUROPEAN STANDARD NORME EUROPÉENNE EUROPmSCHE NORM June 2000 ICs 11.180;97.140 English version Adjustable beds for disabled persons - Requirements and test methods Lits réglables pour les personnes handicapées et méthodes d'essai - Exigences Verstellbare Betten für behinderte Menschen Anforderungen und Prufveríahren This European Standard was approved by CEN on 11 May 2000 CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditionsfor giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographicalreferences concerning sich national standards may be obtained on application to the Central Secretariat or to any CEN member This European Standard exists in three official versions (English French, German) A version in any other language made by trarslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as he official versions CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN D E N O R M A L I S A T I O N E U R O P Ä I S C H E S KOMITEE FOR N O R M U N G Central Secretariat: rue da Stassart, 36 8-1050 Brussels Q 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members COPYRIGHT European Committee for Standardization Licensed by Information Handling Services Ref No EN 1970:2000E 标准分享网 www.bzfxw.com 免费下载 Page EN 1970:2000 4.1 4.2 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.3 5.3.1 5.3.2 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.4.9 5.4.10 5.4.11 5.4.12 5.4.13 5.4.14 5.4.15 5.4.16 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 5.5.6 5.5.7 5.5.8 5.5.9 5.6 5.7 5.8 5.8.1 5.8.2 5.8.3 5.9 5.10 5.11 5.12 5.12.1 5.12.2 5.13 (B BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 Page EN 1970:2000 Foreword This European Standard has been prepared by Technical Committee CENTTC 293, Technical aids for disabled persons, the Secretariat of which is held by SIS This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2000, and conflicting national standards shall be withdrawn at the latest by December 2000 This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s) For relationship with EU Directive(s),see informative Annex ZA, which is an integral part of this standard According to the CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom This standard provides one means to demonstrate that adjustable beds for disabled persons, which are also medical devices, conform to the essential requirements outlined in general terms in Annex of the EU Directive 93/42/EEC It is not intended to provide a means to show conformity with the requirements of any other directive There are three levels of European Standards dealing with technical aids for disabled persons These are as follows, with level being the highest: Level 1: General requirements for technical aids Level 2: Particular requirements for families of technical aids Level 3: Specific requirements for types of technical aids Where standards for particular aids or groups of aids exist (level or 3), the requirements of lower level standards take presedence over higher level standards Therefore, to address all requirements for a particular aid, it is necessary to start with standards of the lowest available standard This is a combined level 2-and 3- standard (lowest possible) for adjustable beds for disabled persons, which are also medical devices, as specified in the scope BSI 082000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services STD-BSI BS EN L970-ENGL 2000 M L b b b 08b5982 5 Page EN 1970:2000 Introduction This standard is intended to apply to the most common products, but certain products will have to fulfil further or other requirements, e.g regarding ergonomics, depending on the product in question The risk analysis should be used for determining if further or other requirements should be addressed for each specific product Due to the dissimilarity of disabilities to be alleviated, it is not possible to specify requirements for adjustable beds for disabled persons in such a way that any bed of this type is covered The present standard is therefore intended to cover the major part of adjustable beds for disabled persons Certain beds, e.g those designed to meet special needs, might need to fulfil other or further requirements, e.g regarding ergonomics or EMC, than specified in this standard Beds covered by the present standard differ from beds covered by the IEC standard on electrically operated hospital beds, e g due the following characteristics: - beds for disabled persons are intended to be used instead of domestic beds for permanent use, with the intention of alleviating or compensating for a disability or handicap and to facilitate better working conditions for attendants; - beds for disabled persons not require the same level of strength and cleaning as hospital beds, due to the different application; - beds for disabled persons not require the same electrical performance as hospital beds due to the different application Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 Page EN 1970:2000 Scope This standard specifies essential requirements and related test methods for non-electricallyand electrically operated adjustable beds, including detachable bed boards, bed lifts, side rails, grab handles and lifting poles intended to be used by disabled persons to alleviate or compensate for a disability or handicap The standard also applies to stand up beds The standard does not apply to lateral tilt beds The standard does not apply to beds intended for use in the diagnosis, treatment or monitoring of patients under medical supervision (covered by EN 60601-2-38 for electrically operated hospital beds) The standard does not apply to ordinary domestic beds, beds intended for children under 12 years of age, and mattresses The requirements in this standard not take into account extreme heavy duty use of the bed Normative references This European Standard incorporates by dated or undated reference, provisions from other publications These normative references are cited at the appropriate places in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard, only when incorporated in it by amendment or revision For undated references the latest edition of the publication referred to applies (including amendments) EN 1441 Medical devices - Risk analysis EN 60529 Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 60601-1 Medical electrical equipment - Part : General requirements for safety EN 60601-1 -211 993 Medical electrical equipment - Part : General requirements for safety Section 2:Collateral standard: Electromagnetic compatibility - Requirements and test methods EN 61000-3-2 Electromagnetic compatibility (EMC) - Part 3:Limits - Section 2:Limits for harmonic current emissions (equipment input current 16 A per phase) EN 61000-3-3 Electromagnetic compatibility (EMC) - Part 3:Limits - Section 3:Limitation of voltage fluctuation and flicker in low-voltage supply systems for equipment input current i 16 A EN 61000-4-3 Electromagnetic compatibility (EMC) - Part 4:Testing and measurement techniques - Section 3:Radiated radio-frequency, electromagnetic field immunity test Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services STD=BSI BS EN 1970-ENGL 2000 m L b b b OBb5984 325 Page EN 1970:2000 EN I S 3746 Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (IS0 3746:1995) EN IS0 14253-1 Geometrical Product Specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformance or non-conformance with specifications (IS0 14253-1:1998) I S 2439 Flexible cellular polymeric materials - Determination of hardness (indentation technique) GUM Guide to the Expression of Uncertainty in Measurement - GUM - 1st edition 1995 issued by BIPM, IEC, ISO, IUPAC, IUPAP, OIML ISBN 92-67-1O188-9 Terms and definitions For the purposes of this standard the following terms and definitions apply: 3.1 Adjustable bed Bed with one or more sections of the mattress support platform that can be adjusted in height and/or angle The adjustment can be non-electrically or electrically operated NOTE: Whenever the term "bed" is used it comprises detachable bed boards, bed lifts and accessories 3.2 Bed lift Height adjustable undercarriages on which a standard bed can be mounted, thus serving as a height adjustable bed 3.3 Stand up bed Bed capable of raising the disabled person to a standing position 3.4 Knock-down bed Bed intended to be disassembled into few main parts for storage or transportation 3.5 Safe working load (SWL) Maximum permissible load (of disabled person, mattress, bed linen and accessories and those parts of the bed intended to be lifted by the bed lift) to operate the bed safely 3.6 Grab handle Supporting structure for the disabled when getting in and out of bed, and when turning from one side to the other in bed 3.7 Side rail Fold-away or removable rail intended to prevent the disabled to fall out of the bed BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 Page EN 1970:2000 3.8 Lifting pole: Device suspended above the bed intended to enable the disabled person to change position by gripping it 3.9 Control unit: Device that controls the drives that activate various functions of electrically operated beds 3.1O Hold-to-run control device: Control device which initiates and maintains operation of operating elements, only as long as the manual control (actuator) is actuated The manual control (actuator) returns automatically to the stop position when released 3.11 Under bed clearance: Space beneath the bedstead base which is not occupied by the castors, legs or other constructional parts 3.12 Normal reach for fingers: Parts of the upper bed and parts under the bed (see figure 1) which are placed at a distance of less than 200 mm from upper/lower part of the outer edge of the bed board as shown in figure 3.13 Normal reach for feet: Parts under the bed which are placed at a distance of less than 120 mm from the vertical line of the outer edge of the bed board 3.14 Moving parts: Parts that are movable in relation to each other or in relation to a fixed part 3.15 Bed board: Mattress support platform and its frame, if any The nomenclature is given in figures to (the figures are only intended to illustrate the nomenclature) 2 Outer edge of bed board Distance 200 mm Potential squeezing or shearing point - Figure Normal reach for fingers Q BSI Oô-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services ~~ 标准分享网 www.bzfxw.com 免费下载 STD-BSI BS EN 1970-ENGL 2000 Zb24bb9 OBbb005 758 Page 28 EN 1970:2000 l\ / \\ / + I 1 f / \ A I Mattress thickness h, (lowest part of seat section) (highest point of side) Mattress - Figure 14 Height of seat section 5.5.3 Under bed clearance With the mattress support platform lowered to any position higher than 400 mm, the height of the under bed clearance shall be at least 150 mm at a length of at least 500 mm positioned on each side of the symmetry plane of the mattress support platform (see figure 15) If the bedbed lift is intended and designed to be used with certain identified hoists only, the under bed clearance need not to fulfil the above given requirement if information is given in the instructions for use Dimensions in millimeters Symmetry plane Bed Under bed clearance - Figure 15 Under bed clearance BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services STD*BS1 BS EN Lq70-ENGL 2000 m Lb24bbq n8bb00b 694 Page 29 EN 1970:2000 5.5.4 5.5.4.1 Angles of mattress support platform Two section mattress support platform The angle A between the back rest section and the bed board frame shall at least be adjustable within the range of O" (horizontal) and 70" A maximum of 85" shall only be reachable when the bed is intended to raise a disabled person to an upright sitting position for transfer If adjustable, the angle B between the leg section and horizontal shall be adjustable between O" and at least 12" The angle C between the back rest section and the leg section shall be greater than 90" - Figure 16 Angles of two section mattress support platform 5.5.4.2 Three section mattress support platform The ans,v A between the back rest section and the bed board frame shall at least be ac, Jstable within the range of O" (horizontal) and 70" A maximum of 85"shall only be reachable when the bed is intended to raise a disabled person to an upright sitting position for transfer The angle B between the upper leg section and horizontal shall be adjustable between O" and at least 12" The angle C between the back rest section and the upper leg section shall be greater than 90" The angle D between the lower leg section and horizontal shall be adjustable between O" and at least 20' under horizontal The angle E between the upper side of the upper leg section and the upper side of the lower leg section shall be at least 180" Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services ~ ~ STD.BSI BS EN - E N G L 2000 Page 30 EN 1970:2000 - 标准分享网 www.bzfxw.com 免费下载 L b b b 08hh007 520 - Figure 17 Angles of three section mattress support platform - Figure 18 Angles of three section mattress support platform 5.5.4.3 Four section mattress support plform The angle A between the back rest section and the bed board frame shall at least be adjustable within the range of O" (horizontal) and 70" A maximum of 85" shall only be reachable when the bed IS intended to raise a disabled person to an upright sitting position for transfer The angle B between a line drawn between the turning point of the back rest section/seat section and the turning point of the upper/lower leg section and horizontal shall be adjustable between O" and at least 12" Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services STDUBS1 B S EN L770-ENGL 2000 I1624669 0866008 4b7 Page 31 EN 197O:ZOOO The angle C between the back rest section and a line drawn between the turning point of the back rest section/seat section and the turning point of the upper/lower leg section shall be greater than 90" The angle D between the lower leg section and horizontal shall be adjustable between O" and at least 20" under horizontal The angle E between the upper side of the upper leg section and the upper side of the lower leg section shall be at least 180" - Figure 19 Angles of four section mattress support platform Ca BSI 082000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 STDmBSI BS EN 1970-ENGL 2000 1624669 OBbb009 3T3 W Page 32 EN 1970:2000 5.5.5 Dimensions of side rails and grab handles Distances (see figures 20 and 21) between elements of side rails/grab handles and between side raildgrab handles and elements of the bedlaccessories shall fulfil the requirements given in table Table 1: Dimensions of side raildgrab handles Designation Dimension Requirement mm A The greatest dimension in at least one direction between elements inside of the perimeter of the side rail/grab handle in all normal use positions A i 120 B Thickness of normal use mattress as specified by the manufacturer without compression As specified by the manufacturer C Height of the top of the side rail above the mattress without compression and with the bed board in flat position C L 220 mm D Distance between the head end panelífoot end panel/ accessories and the side rail/grab handle with the bed board in flat position Applies also if the end panels are extended D i 60 or D 250 E Distance between segmented side rails with the bed board in flat position F The greatest dimension in at least one direction of any accessible opening below the side rail, either E160 or 250 E i 400 if D or E L 250 if Dor E i 60 then: F < 120 No requirements Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services S T D U B S BS EN L970-ENGL 2000 Lb24bb9 O B b b O L O 015 Page 33 EN 1970:2000 - D iD G & .I c qr r 1: I A :: : I I I ' i I I A > U I - Figure 20 Dimensions of single piece side rails - Figure 21 Dimensions of segmented side rails O BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services ~ I B r 标准分享网 www.bzfxw.com 免费下载 Page 34 EN 1970:2000 5.5.6 Test methods for determining the distance between any elements of the side raivgrab handle and between any elements of the side rail/grab handle and their supporting structure Press the relevant cone as specified in 5.2.6 between any elements of the side rail/grab handle and/or between any elements of the side rail/grab handle and their supporting structure with 30 N Check that any distance between elements fulfils the requirement of 5.5.5 during application of the force 5.5.7 Distances to the handle of the lifting pole The horizontal distance between the outer edge of the mattress support platform in the head end and the centre of the handle of the lifting pole shall be between 600 mm and 850 mm measured at the centre line of the bed The height of a handle of the lifting pole shall be adjustable 5.5.8 Dimensions of the control unit The surface of buttons shall at least cover a circle of 15 mm in diameter Any distance between buttons shall be more than 10 mm NOTE: The buttons may have any shape, e.g they need not to be circular 5.5.9 Dimensions of handles and pedals All handles and pedals shall be reachable from normal working positions and be placed so they allow operations to be carried out in a safe and ergonomic manner The free distance between any handle (those parts intended to be grabbed) requiring an operating force of more than 10 N and any construction part shall be more than 35 mm The free distance between the upper side of any pedal (those parts intended to be stepped on) and any construction part shall be more than 75 mm The diameter of operating handles requiring an operating force of more than 1O N shall be between 19 mm and 43 mm Pedals shall be placed not more than 300 mm over the surface of the floor 5.6 Operating forces In the case of electrically operated functions, the force to operate the control unit buttons shall be less than N In the case of non-electrically operated functions, the force to release operating handles shall be no more than 10 N and the force required to lift any part of the bed board shall be no more than 200 N, when loads are fixed to the bed board as shown in figure 22,with their centre of gravity in the middle of the sections Q BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services STD-BSI BS EN L970-ENGL 2000 Lb24bb9 08bbOl12 998 = Page 35 EN 1970:2000 The static force to operate pedals shall be no more than 300 N when loads are fixed to the bed board, as shown in figure 22, with their centre of gravity in the middle of the sections I 400 N 2ûûN l 150N 150N I Back rest section Seat section Upper leg section Lower leg section - Figure 22 Loading of bed board 5.7 Operating speed and time If electrically operated, the average speed of height adjustment of the mattress support platform shall be within 10 mm/s to 30 mm/s when loaded as shown in figure 22 If electrically operated, the time to adjust other elements of the mattress support platform shall be less than 30 s, when loaded as shown in figure 22 It shall take more than s to raise the back rest section to an upright position when unloaded and without the mattress, and more than s by normal operation to lower it to horizontal position, when fitted with the mattress and loaded as shown in figure 22 5.8 Additional requirements regarding stand up beds The stand-up function shall be mentioned in the instructions for use It shall be possible to adjust the bed board longitudinally to any angle from horizontal to an upper limit between 75"and 85",so that the head end becomes higher than the foot end The foot end panel shall withstand a vertical downward force of twice the safe working load of the person (see 4.1) placed at the centre of the end panel, when the mattress support platform is adjusted to its maximum angle to horizontal The bed shall be equipped with a mechanism allowing emergency soft lowering It shall not be possible to raise the back rest to an angle of more than 85"in relation to horizontal in any position of the bed BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 www.bzfxw.com 免费下载 STD-BSI BS EN 1970-ENGL 2000 Page 36 EN 1970:2000 When tested in accordance with 5.8.3 the bed shall not overbalance Accessories shall not become loose due to change in the position of the bed board The bed, if not intended for transfer from the bed in upright position, shall be equipped with length adjustable straps, designed and placed to maintain the disabled person in the up-right position The straps shall have a quick release mode The straps shall have no visible defects when tested in accordance with 5.8.2 5.8.1 Stand-up beds intended for transfer from the bed in upright position The foot end panel shall be able to be adjusted to horizontal when the mattress support platform is adjusted to its maximum angle to horizontal The mattress shall be fixed to the mattress support platform The distance between the foot end panel and the floor shall be less than 25 mm when the mattress support platform is adjusted to its maximum angle to horizontal The distance shall not fulfil the dimensional requirements given in clause A device shall stop raising the bed into the up-right position when an outside force of more than 20 N is met by those parts coming closer than 120 mm to the floor 5.8.2 Test methods for straps for stand-up beds Apply 10 times a tensile force of 500 N to the strap Examine that the strap and its fastenings have not fractured or become loose or open, and that the lock is still functioning and that all parts have no visible defects after removal of the force 5.8.3 Test methods for the stability of stand up beds Load the bed board with the safe working load (see 4.1) distributed and fixed to the bed board as shown in figure 23, with the centre of gravity of the loads at the middle of the sections and 150 mm above the mattress support platform Apply a force of 200 N to the top of the fully raised bed board in any horizontal direction Examine whether the bed overbalances during the application of the force á) COPYRIGHT European Committee for Standardization Licensed by Information Handling Services BSI 08-2000 S T D - B S I B S EN L970-ENGL 2000 W Lb24bb9 OBbbOL4 b Page 37 EN 1970:2000 I 45 % 25% 2 15% 15 % I Back rest section Seat section Upper leg section Lower leg section - Figure 23 Distribution of the SWL onto the bed board 5.9 Immobilization For beds provided with wheels, it shall be possible to immobilize it so that the fastenings of the wheels will not move more than 10 mm when tested in accordance with 5.10 5.10 Test method for immobilization Place the bed on a flat and rigid vinyl covered surface Immobilize the unloaded bed as described in the instructions for use Position the wheels in the most adverse position If adjustable in height, position the bed board in the highest position Apply a horizontal force of 270 N for 30 s in the most adverse point of the bed Record the movement of the fastenings of the wheels 5.11 Electrotechnicalrequirements The requirements specified in EN 60601-1 apply when subjects are not covered by this particular standard NOTE: The attention is drawn to the fact that in some countries the bed should be supplied with double insulation because mains power connections with suitable protective earthing are not available The degree of protection of electrotechnical parts provided by enclosures shall be at least IPX 4, in accordance with EN 60529 NOTE: It is recommended that in most situations, the length of cable for power supply should be within m and 3,5m from the furthest edge from the fixation of the cable on the bed 5.12 EMC requirements The equipment shall fulfil the requirements specified in EN 60601-1-2 and shall in addition fulfil the following thenviserequested Information on standards BSI provides a wide range of information on nataonal, European and international standards through its Library and its Technical Help to Exporters Service.Various BSI electronic information services are also available which give details on ail its x-oductsand services Contact the Information Centre Tel 020 8996 7111 Fax 020 8996 7048 hbscribing members of BSI are kept up to date with standards developments and -eceivesubstantiai discounts on the purchase price of standards For details of hese and other benefits contact Membership Admhktmh'on Tel 020 8996 7002 ?ax020 8996 7001 Zopyright 2opynght subsists in all BSI publications BSI also holds the copyright, in the UK, of he publications of the international standadhion bodies Except as permitted mder the Copyright, Designs and Patents Act 1988no extract may be 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