BS EN 12470-3-2000+A1-2009 医用体温计.最大装置小型电体温计(非预测型和预测型)的性能.pdf
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1、 - P - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - w - - - - - EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-3:2000+A1 June 2009 ICS 17.200.20 Supersedes EN 12470-3:2000 English Version Clinical thermometers - Part 3: Performance of compact electrical
2、 thermometers (non-predictive and predictive) with maximum device Thermomtres mdicaux - Partie 3: Performances des thermomtres lectriques compacts ( comparaison et extrapolation) avec dispositif maximum Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompak
3、tthermometer mit Maximumvorrichtung This European Standard was approved by CEN on 13 May 1999 and includes Amendment 1 approved by CEN on 16 May 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status
4、 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 CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A v
5、ersion in any other language made by translation under the respons bility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
6、 Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORM
7、ALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12470-3:2000+A1:2009: E EN 12470-3:2000+A1:2009 (E) 2 Contents Page Foreword 3 1Scop
8、e 4 2Normative references 4 3Definitions 4 4Unit 5 5Types of thermometers .5 6Performance requirements .5 7Test methods 8 8Information supplied by the manufacturer 14 Annex A (informative) Suggested types of testing for the requirements of this standard . 16 Annex B (informative) Bibliography . 18 A
9、nnex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC“ . 19 BS EN 12470-3:2000+A1:2009 EN 12470-3:2000+A1:2009 (E) 3 Foreword This document (EN 12470-3:2000+A1:2009) has been prepared by Technical Committee CEN/TC 205 “Non- active
10、 medical devices“, the secretariat of which is held by DIN. 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 2009, and conflicting national standards shall be withdrawn at the latest by Ma
11、rch 2010. This document includes Amendment 1, approved by CEN on 2009-05-16. This document supersedes EN 12470-3:2000. The start and finish of text introduced or altered by amendment is indicated in the text by tags ! “. This European Standard has been prepared under a mandate given to CEN by the Eu
12、ropean 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. This European Standard applies to clinical thermometers which are used for m
13、easuring the body temperature of humans. EN 12470 consists of the 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 thermomet
14、ers (non-predictive and predictive) with maximum device Part 4: Performance of electrical thermometers for continuous measurements Part 5: Performance of infra-red ear thermometers (with maximum device) Annexes A, B and ZA are informative. According to the CEN/CENELEC Internal Regulations, the natio
15、nal standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, P
16、oland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 12470-3:2000+A1:2009 EN 12470-3:2000+A1:2009 (E) 4 1 Scope This Part of EN 12470 specifies the performance requirements for compact clinical electrical thermometers with maximum device (non-predictive
17、and predictive). This European Standard applies to devices that, when taking temperatures, are powered 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 thermomete
18、rs intended to measure skin temperature. 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 refer
19、ences, 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. EN 980, !Symbols for use in the labelling of medical devi
20、ces“ EN 1041, Information supplied by the manufacturer with medical devices prEN 12470-1:1998, Clinical thermometers Part 1: Metallic liquid-in-glass thermometers with maximum device EN 60601-1, !Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IE
21、C 60601-1:2005) “ EN 60601-1-2, Medical electrical equipment Part 1: General requirements for safety 2: Collateral Standard - Electromagnetic compatibility - Requirements and tests ISO 2859-2: 1985, Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (
22、LQ) for isolated lot inspection 3 Definitions For the purposes of this Part of EN 12470 the following definitions apply: 3.1 compact electrical thermometer contact thermometer that consists of a temperature probe and an indicating unit permanently connected together 3.2 compact predictive thermomete
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- BS EN 12470-3-2000+A1-2009 医用体温计.最大装置小型电体温计非预测型和预测型的性能 12470 2000 A1 2009 医用 体温计 最大 装置 小型 预测 性能
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