BS-EN-12523-1999.pdf
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1、BRITISH STANDARD BS EN 12523:1999 Incorporating Corrigendum No. 1 External limb prostheses and external orthoses Requirements and test methods The European Standard EN 12523:1999 has the status of a British Standard ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:18 GMT+
2、00:00 2006, Uncontrolled Copy, (c) BSI BS EN 12523:1999 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 15 June 1999 BSI 21 February 2003 ISBN 0 580 3
3、2072 3 National foreword This British Standard is the English language version of EN 12523:1999. It supersedes BS 2574-3:1990 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/168, Prosthetics orthotics, which has the responsibility to: A list of org
4、anizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Corre
5、spondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not
6、of itself confer immunity from legal obligations. aid enquirers to understand 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 international and European developments and promulga
7、te them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 57 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No.DateCommen
8、ts 14082 Corrigendum No. 1 21 February 2003Revision of national foreword Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12523 January 1999 ICS 11.180 Descriptors: medical equipment, surgi
9、cal implants, prosthetic devices, orthotics, definitions, specifications, materials, toxicity, contamination, flammability, safety, design, mechanical strength, operating requirements, ergonomics, tests, information English version External limb prostheses and external orthoses Requirements and test
10、 methods Prothses de membre externes et orthses externes Exigences et mthodes dessai Externe Gliedmaenprothesen und externe Orthesen Anforderungen und Prfverfahren This European Standard was approved by CEN on 8 November 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations
11、 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 such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European
12、 Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national
13、 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. CEN European Committee for Standardization Comit Europen de Normalisation Europisches K
14、omitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12523:1999 E Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:30:18 GMT+00:00 2006, Uncontroll
15、ed Copy, (c) BSI EN 12523:1999 BSI 21 February 2003 2 Foreword This European Standard has been prepared by Technical Committee CEN/TC 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
16、publication of an identical text or by endorsement, at the latest by July 1999, and conflicting national standards shall be withdrawn at the latest by July 1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement
17、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 European Standard has been prepared under a mandate given to CEN by the Eur
18、opean Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex Z, which is an integral part of this standard. This standard provides one means to demonstrate that external limb prostheses
19、and external orthoses, 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 S
20、tandards dealing with technical aids for disabled persons. These are as follows, with level 1 being the highest. Where standards for particular aids or groups of aids exist (level 2 or 3), the requirements of lower level standards take precedence over higher level standards. Therefore, to address al
21、l requirements for a particular aid, it is necessary to start with standards of the lowest available level. This is a combined level 2 and 3 standard (lowest possible) for external limb prostheses and external orthoses, as specified in the scope. In this standard, in addition to the reference to exi
22、sting test standards, test methods for several types of prostheses and orthoses are specified in separate Annex A, Annex B, Annex C and Annex D. Annex Z (informative) is included to show the parts of this European Standard which address the essential requirements of EU Directive 93/43/EEC. NOTE 1The
23、 test methods specified in Annex A and Annex C require further work on evaluation of practicality and/or amendment/completion and/or verification/validation to establish the basis from which to decide on a change of their status. In order to allow their use as guidance, for the purposes of this edit
24、ion of EN 12523, they are included as informative parts. The test methods specified in Annex D have primarily been developed and applied to establish a database from which to decide on the applicability of ranges of operating force specified in EN 614-1 and/or other standards referred to therein suc
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