BS EN 12470-5-2003 Clinical thermometers — Part 5 Performance of infra-red ear thermometers (with maximum device)1.pdf
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1、BRITISH STANDARD BS EN 12470-5:2003 Clinical thermometers Part 5: Performance of infra-red ear thermometers (with maximum device) The European Standard EN 12470-5:2003 has the status of a British Standard ICS 17.200.20 ? BS EN 12470-5:2003 This British Standard was published under the authority of t
2、he Standards Policy and Strategy Committee on 25 April 2003 BSI 25 April 2003 ISBN 0 580 41677 1 National foreword This British Standard is the official English language version of EN 12470-5:2003. The UK participation in its preparation was entrusted by Technical Committee LBI/36, Laboratory glassw
3、are and related apparatus, to Subcommittee Thermometers, LBI/36/3 which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications refer
4、red to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence 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 provis
5、ions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation,
6、or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 28, an inside back cover and a back cover.
7、The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12470-5 April 2003 ICS 17.200.20 English version Clinical thermometers - Part 5: Performance o
8、f infra-red ear thermometers (with maximum device) Thermomtres mdicaux - Partie 5: Performance des thermomtres tympaniques infrarouges (avec dispositif maximum) Medizinische Thermometer - Teil 5: Anforderungen an Infrarot- Ohrthermometer (mit Maximumvorrichtung) This European Standard was approved b
9、y CEN on 27 December 2002. 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 sta
10、ndards may be obtained on application to the Management Centre 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
11、the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Swede
12、n, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
13、Ref. No. EN 12470-5:2003 E EN 12470-5:2003 (E) 2 Contents page Foreword3 1Scope 4 2Normative References.4 3Terms and definitions4 4Unit5 5Type of thermometers .5 6Requirements.6 6.1General6 6.2Range of displayed temperature6 6.3Maximum permissible error6 6.4Environmental requirements6 6.5Indicating
14、unit.7 6.6Construction.8 7Test Methods9 7.1General9 7.2Sampling.9 7.3Testing for compliance of the range of displayed temperature9 7.4Testing for compliance of the maximum permissible error within ambient operating range .10 7.5Testing for compliance of maximum permissible error under extended opera
15、ting conditions11 7.6Testing for compliance of maximum permissible error under changing environmental conditions.12 7.7Testing for compliance with maximum permissible clinical repeatability - Procedure13 7.8Testing for compliance with the effect of storage and long term stability14 7.9Method of test
16、 for mechanical shock 14 7.10Testing for compliance with the variation of the supply voltage14 7.11Testing for compliance with cleaning and disinfection.15 8Information supplied by the manufacturer16 8.1General16 8.2Marking .16 8.3Instructions for use .16 Annex A (informative) Clinical trial to dete
17、rmine clinical accuracy18 A.1Introduction18 A.2Clinical accuracy18 A.3Clinical trial procedure18 A.4Clinical bias and its standard deviation19 A.5Clinical repeatability19 Annex B (informative) Suggested types of testing for the requirements of this standard.21 Annex C (informative) Example for a sui
18、table design of a black body radiator 23 Annex D (informative) Alternative approaches to prove compliance with 6.3.26 D.1General26 D.2Separation of the maximum permissible error for the instrument and for the probe covers26 D.3Calculation of the error using error propagation analysis26 Annex ZA (inf
19、ormative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives27 Bibliography28 w w w . b z f x w . c o m EN 12470-5:2003 (E) 3 Foreword This document (EN 12470-5:2003) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices
20、“, 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 latest by October 2003, and conflicting national standards shall be withdrawn at the latest by October 2003. This
21、document 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 document. This Europe
22、an Standard applies to clinical thermometers which are used for measuring 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)
23、 thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Part 4: Performance of electrical thermometers for continuous measurement Part 5: Performance of infra-red ear thermometers (with maximum device) Annexes A, B, C, and D are inform
24、ative. 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, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, N
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