Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

This Part of EN 12470 specifies performance requirements and test methods for phase change-type (dot matrix) thermometers for measuring temperature in body cavities.
NOTE   A body cavity can be the mouth, rectum or armpit.
This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for hypothermia) which owing to their measurement range, scale interval or maximum permissible error do not meet the requirements specified in this Standard.

Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix)

Dieser Teil der EN 12470 legt Anforderungen an die Gebrauchstauglichkeit von Phasenumschlag-
Thermometern (Punktmatrix) zur Messung der Temperatur in Körperhöhlen, sowie deren Prüfverfahren fest.
ANMERKUNG Eine Körperhöhle kann der Mund, das Rektum oder die Achselhöhle sein.
Diese Europäische Norm gilt nicht für medizinische Thermometer, die für spezifische Anwendungen (z. B.
Thermometer für Hypothermie) ausgelegt sind und die durch ihren Messbereich, ihre Skalenteilung oder ihre
maximal zulässige Messabweichung nicht die in dieser Norm festgelegten Anforderungen erfüllen.

Thermomètres médicaux - Partie 2: Thermomètres à changement de phase (matrice à points)

La présente partie de l'EN 12470 spécifie les exigences de performance et les méthodes d'essai relatives aux
thermomètres à changement de phase (matrice à points) mesurant la température du corps dans des orifices de
celui-ci.
NOTE Ces orifices peuvent être la bouche, le rectum ou l'aisselle.
La présente Norme européenne ne s'applique pas aux thermomètres médicaux conçus pour des applications
particulières (par exemple les thermomètres pour l'hypothermie) qui, de par leur étendue de mesure, leur graduation
ou leur erreur maximale tolérée, ne satisfont pas aux exigences de la présente norme.

Klinični termometri - 2. del: Termometri, ki zaznavajo spremembo faze (točkovna matrica)

General Information

Status
Published
Publication Date
16-Jun-2009
Current Stage
9093 - Decision to confirm - Review Enquiry
Completion Date
05-Jun-2023

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.PDWULFDMedizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix)Thermomètres médicaux - Partie 2: Thermomètres à changement de phase (matrice à points)Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12470-2:2000+A1:2009SIST EN 12470-2:2001+A1:2009en,fr,de01-oktober-2009SIST EN 12470-2:2001+A1:2009SLOVENSKI
STANDARD



SIST EN 12470-2:2001+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12470-2:2000+A1
June 2009 ICS 17.200.20 Supersedes EN 12470-2:2000English Version
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
Thermomètres médicaux - Partie 2: Thermomètres à changement de phase (matrice à points)
Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix) This European Standard was approved by CEN on 16 September 2000 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 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 version in any other language made by translation under the responsibility 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, 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
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 12470-2:2000+A1:2009: ESIST EN 12470-2:2001+A1:2009



EN 12470-2:2000+A1:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Terms and definitions .44Unit .55Type of thermometers .56Requirements .57Test methods .78Information supplied by the manufacturer . 10Annex A (informative)
Suggested types of testing for the requirements of this standard . 13Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 15Bibliography . 17 SIST EN 12470-2:2001+A1:2009



EN 12470-2:2000+A1:2009 (E) 3 Foreword This document (EN 12470-2:2000+A1:2009) has been prepared by Technical Committee CEN/TC 205 "Non-active 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 March 2010. This document includes Amendment 1, approved by CEN on 2009-05-16. This document supersedes EN 12470-2:2000. The start and finish of text introduced or altered by am
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