BS EN 1970-2000 Adjustable beds for disabled persons -Requirements and test methods.pdf

STD-BSI BS EN 1970-ENGL 2000 H Lb24bb9 0865976 259 I I BRITISH STANDARD Adjustable beds for disabled persons - Requirements and test methods The European Stanàard EN 1970 British Standard ICs 11.180, 97.140 as the status of a BS EN L970:2000 NO COPYING WITEIOUT BSI PERMISSION EXCEPT AS PERMIWED BY COPYRIGIIT LAW COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services BS EN 19702000 This B r i t i s h 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 i n t o effect on 15 August Zoo0 6 BSI û8-2ûûû ISBN O 680 36036 9 National foreword This British Standard is the official English language version of EN 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 - monitor related intedoml and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed; them in the UK A list of organizations represented 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 t h i s 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 standards are 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 2 to 41 and a back cover. The BSI copyright notice displayed in this document indicates when the document was l a s t issued. Amendments issued since publication COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 w w w .b z f x w .c o m 免费下载 STD.BS1 BS EN Lï70-ENGL 2000 H Lb24bbï OBbsq78 021 m EUROPEAN STANDARD EN 1970 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 - Exigences et méthodes d'essai 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 conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references 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 NORMALISATION EUROPÄISCHES KOMITEE FOR NORMUNG 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. Ref. No. EN 1970:2000 E COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services Page 2 EN 1970:2000 1 2 3 4 4 . 1 4.2 5 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 . 1 1 5.4.12 5 . 4 . 1 3 5.4.14 5 . 4 . 1 5 5 . 4 . 1 6 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 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 w w w .b z f x w .c o m 免费下载 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 . 1 1 5.12 5.12.1 5.12.2 5.13 6 7 (B BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services Page 4 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 1 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 1 being the highest: Level 1: Level 2: Level 3: General requirements for technical aids Particular requirements for families of technical aids Specific requirements for types of technical aids. Where standards for particular aids or groups of aids exist (level 2 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. 8 BSI 082000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 w w w .b z f x w .c o m 免费下载 STD-BSI BS EN L970-ENGL 2000 M Lb24bb9 08b5982 552 Page 5 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 do not require the same level of strength and cleaning as hospital beds, due to the different application; - beds for disabled persons do 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 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services Page 6 EN 1970:2000 1 Scope This standard specifies essential requirements and related test methods for non-electrically and 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 do not take into account extreme heavy duty use of the bed. 2 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 EN 60529 EN 60601-1 EN 60601 -1 -211 993 EN 61000-3-2 EN 61000-3-3 EN 61000-4-3 Medical devices - Risk analysis Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) Medical electrical equipment - Part 1 : General requirements for safety Medical electrical equipment - Part 1 : General requirements for safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and test methods Electromagnetic compatibility (EMC) - Part 3: Limits - Section 2: Limits for harmonic current emissions (equipment input current 5 1 6 A per phase) 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 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 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services 标准分享网 w w w .b z f x w .c o m 免费下载 STD=BSI BS EN 1970-ENGL 2000 m Lb24bb9 OBb5984 325 Page 7 EN 1970:2000 EN IS0 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) IS0 2439 Flexible cellular polymeric materials - Determination of hardness (indentation technique) GUM Guide to the Expression of Uncertainty in Measurement - GUM - 1 st edition 1995 issued by BIPM, IEC, ISO, IUPAC, IUPAP, OIML - ISBN 92-67-1 O 1 88-9 3 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. 8 BSI 08-2000 COPYRIGHT European Committee for Standardization Licensed by Information Handling Services COPYRIGHT European Committee for Standardization Licensed by Information Handling Services Page 8 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. 3.1 O 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. 3.1 1 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 1. 3.1 3 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. 3.1 4 Moving parts: