BS EN 12470-3-2000 Clinical thermometers D Part 3 Performance of compact electrical thermometers (non-predictive and predictive) with maximum device.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12470-3:2000 The Eu
2、ropean Standard EN 12470-3:2000 has the status of a British Standard ICS 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device This British Stan
3、dard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 April 2000 BSI 04-2000 ISBN 0 580 34605 6 BS EN 12470-3:2000 Amendments issued since publication Amd. No.DateCo
4、mments National foreword This British Standard is the official English language version of EN 12470-3:2000. The UK participation in its preparation was entrusted by Technical Committee LBI/36, Laboratory glassware and related apparatus, to Subcommittee LBI/36/3, Thermometers, which has the responsib
5、ility to: 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 promulgate them in the UK. A list of organizatio
6、ns represented on this subcommittee 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 Standards Catalogue under the section entitled International Standards C
7、orrespondence Index, or by using the Find 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 n
8、ot 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 9 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. CEN European Committe
9、e for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12470-3:2000 E EUROPEAN STANDA
10、RDEN 12470-3 NORME EUROPE ENNE EUROPA ISCHE NORM January 2000 ICS 17.200.20 English version Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Thermome tres me dicaux Partie 3: Performances des thermome tres e lectriques c
11、ompacts (a comparaison et a extrapolation) avec dispositif a maximum Medizinische Thermometer Teil 3: Elecktrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung This European Standard was approved by CEN on 13 May 1999. CEN members are bound to comply with the
12、 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 standards may be obtained on application to the Central Secretariat or
13、 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 Central Secretariat has the same status as the official versi
14、ons. 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. Page 2 EN 12470-3:2000 BSI 04-2000 1)In preparation. F
15、oreword This European Standard has been prepared by Technical Committee CEN/TC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the lates
16、t by July 2000, and conflicting national standards shall be withdrawn at the latest by July 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 rela
17、tionship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Den
18、mark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This European Standard applies to clinical thermometers which are used for measuring the body temperature of humans. EN 12470 consists of the
19、 following parts under the general title Clinical thermometers: Part 1: Metallic liquid-in-glass thermometers with maximum device; Part 2: Phase change-type (dot matrix) thermometers; Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device; Part 4:1
20、)Performance of electrical thermometers for continuous measurements; Part 5:1)Performance of infra-red ear thermometers (with maximum device). Annexes A, B and ZA are informative. Contents Page Foreword2 1Scope3 2Normative references3 3Definitions3 4Unit3 5Types of thermometers3 6Performance require
21、ments3 7Test methods5 8Information supplied by the manufacturer7 Annex A (informative) Suggested types of testing for the requirements of this standard8 Annex B (informative) Bibliography8 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions
22、of EU Directives9 Page 3 EN 12470-3:2000 BSI 04-2000 1 Scope This part of EN 12470 specifies the performance requirements for compact clinical electrical thermometers with maximum device (non-predictive and predictive). This European Standard applies to devices that, when taking temperatures, are po
23、wered by an internal power supply and that provide a digital indication of temperature. This European Standard does not apply to clinical electrical thermometers for continuous measurement and thermometers intended to measure skin temperature. 2 Normative references This European Standard incorporat
24、es 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
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