BS-EN-864-1997 BS-5724-2.30-1997.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 864 : 1997 BS 5724
2、: Section 2.30 : 1997 The European Standard EN 864 : 1996 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Medical electrical equipment Capnometers for use with humans Particular requirements Licensed Copy: sheffieldun sheffiel
3、dun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 864 : 1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1997 BSI 1997
4、The following BSI references relate to the work on this standard: Committee reference CH/46 Draft for comment 92/57780 DC ISBN 0 580 27093 9 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was ent
5、rusted to Technical Committee CH/46, Lung ventilators and related equipment, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries Association of Paediatric Anaesthetists British Anaesthetic and Respi
6、ratory Equipment Manufacturers Association British Paediatric Association Department of Health Electro Medical Trade Association Limited Institution of Mechanical Engineers Institution of Physics and Engineering in Medicine and Biology Intensive Care Society Safety Equipment Association Licensed Cop
7、y: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 864 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 8643 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 200
8、6, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 864 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/46 and is the English language version of EN 864 Medical electrical equipment Capnometers for use with humans Particular requirements, published by the Europ
9、ean Committee for Standardization (CEN). It supersedes BS 5724 : Section 2.30 : 1993, which is withdrawn. Cross-references Publication referred toCorresponding British Standard EN 475BS EN 475 : 1995 Medical devices Electrically-generated alarm signals EN 1281-2BS EN 1281 Anaesthetic and respiratory
10、 equipment Conical connectors Part 2 : 1996 Screw-threaded, weight-bearing connectors EN 60601-1 : 1990BS 5724 Medical electrical equipment Part 1 : 1989 General requirements for safety EN 60601-1-2BS EN 60601 Medical electrical equipment Part 1 General requirements for safety Section 1.2 : 1993 Col
11、lateral standard. Electromagnetic compatibility. Requirements and tests EN ISO 3744BS EN ISO 3744 : 1995 Acoustics Determination of sound power level of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane IEC 651BS EN 60651 : 1994 Specification
12、for sound level meters IEC 801-2BS EN 60801 Electromagnetic compatibility for industrial-process measurement and control equipment Part 2 : 1993 Electrostatic discharge requirements Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This do
13、cument comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 20, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite
14、 Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN 864 : 1996 E EUROPEAN STANDARDEN 864 NORME EUROPE ENNE EUROPA ISCHE NORM October 1996 ICS 11.040.10 Descriptors: electromedical e
15、quipment, capnometers, men, safety requirements, accident prevention, detail specifications, protection against electric shocks, protection against mechanical hazard, radiation protection, explosion proofing, fire protection, performance evaluation, tests, marking English version Medical electrical
16、equipment Capnometers for use with humans Particular requirements Appareils e lectrome dicaux Capnome tres pour utilisation chez lhomme Prescriptions particulie res Medizinische elektrische Gera te Kapnometer fu r die Anwendung am Menschen Besondere Anforderungen This European Standard was approved
17、on CEN on 1996-09-14. CEN 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 lists and bibliographical references concerning such national standard
18、s 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 translation under the responsibility of a CEN member into its own language and notified to the
19、 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed
20、 Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 864 : 1996 BSI 1997 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the secretariat of which is held by BSI. This E
21、uropean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 1997, and conflicting national standards shall be withdrawn at the latest by June 1998 This European Standard has been prepared under a mandate give
22、n to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive(s). For relationship with EU Directives, see informative annex ZA, which is an integral part of this standard. Annexes AA, BB and ZA are for information only. According to
23、the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzer
24、land and the United Kingdom. Contents Page Foreword2 Introduction3 Section one. General 1Scope4 2Normative references4 3Terminology and definitions4 4General requirements and general requirements for tests6 5Classification6 6Identification, marking and documents6 7Power input7 Section two. Environme
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