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
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Due Date
02-Dec-2017
Completion Date
02-Dec-2017

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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 amendment is indicated in the text by tags ! ". 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 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 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) 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 and ZA are informative. According to the CEN/CENELEC Internal Regulations, the national 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. SIST EN 12470-2:2001+A1:2009

EN 12470-2:2000+A1:2009 (E) 4 1 Scope 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. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publication. 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 Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 980, !Symbols for use in the labelling of medical devices" EN 1041, Information supplied by the manufacturer with medical devices EN 556+A1, Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile" ISO 2859-2:1985, Sampling procedures for inspection by attributes – Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection 3 Terms and definitions For the purposes of this Part of EN 12470, the following terms and definitions apply: 3.1

measurement time length of time required to measure body temperature 3.2
phase change (dot matrix) thermometer

device utilising a change in state of chemical components designed to measure and indicate human body temperature 3.3

retention time duration of time for which the optimal signal for reading persists 3.4

sensor matrix temperature measuring area consisting of temperature dots NOTE The dots contain different chemical mixtures, which change their state at specific temperatures. This change is accompanied by a change in appearance, e.g. change of colour. When in contact with the temperature site being measured, the change of state takes place in the sequence of dots up to and including the dot corresponding to the temperature of the site. This dot indicates the site temperature. SIST EN 12470-2:2001+A1:2009

EN 12470-2:2000+A1:2009 (E) 5 3.5
temperature offset

designed difference between preadjusted thermometer reading and water bath temperature after reaching thermal equilibrium 3.6

preadjusted thermometer
thermometer which is designed to have a temperature offset 3.7

skipped dot a dot which fails to activate when exposed to a temperature which would have caused activation 3.8

adjacent dots dots which are numerically sequential according to the scale 3.9

storage package smallest original shipping unit used by the manufacturer 4 Unit The unit of temperature shall be the degree Celsius, symbol °C. 5 Type of thermometers Thermometers covered by this Part of EN 12470 are either of the single-use type or the multiple-use type. Thermometers are classified by their measuring range into the following types: a) short scale type with a measuring range of 35,5 °C to 40,4 °C; b) long scale type with a minimum measuring range of 35,5 °C to 42,0 °C. 6 Requirements 6.1 Scale 6.1.1 Measuring range and scale interval The thermometer shall cover one of the measuring ranges specified in clause 5 with a scale interval no greater than 0,1 °C. Testing shall be performed by visual inspection. 6.1.2 Scale marks and numbering Numerals shall be placed at least at every degree graduation on the scale. Testing shall be performed by visual inspection. SIST EN 12470-2:2001+A1:2009

EN 12470-2:2000+A1:2009 (E) 6 6.1.3 Temperature indication There shall be a distinct difference in appearance before and after the change of the state of the thermometer dots. Testing shall be performed by visual inspection. 6.2 Measurement retention Any temperature measurement reading of the thermometer shall be maintained for a minimum period of 20 s after the thermometer has been removed from the test site and has been allowed to stabilise at room temperature (23 ± 5) °C. Testing shall be performed in accordance with 7.2. 6.3 Regeneration The thermometer shall be designed in such a way that if it has been partially or totally activated, it can be returned to functional condition and accuracy by a method specified by the manufacturer. Testing shall be performed in accordance with 7.4. 6.4 Effect of storage After testing in accordance with 7.3 the thermometer shall meet the requirements specified in 6.5. 6.5 Maximum permissible error under reference conditions The maximum permissible error shall not exceedCC°+°−1,02,0 for each individual dot.

Testing shall be performed in accordance with 7.2. The temperature difference necessary to activate two adjacent dots shall not exceed 0,2 °C.

Testing shall be performed in accordance with 7.5.

If the thermometer has an offset, the offset shall be uniform throughout the measuring range of the thermometer. 6.6 Skipped dots The thermometer shall not have two adjacent skipped dots. The total number of skipped dots shall not be greater than 5 % of the total number of dots for that thermometer. Testing shall be performed in accordance with 7.6. 6.7 Thermometers supplied sterile Thermometers which are labelled "STERILE" shall comply with EN 556+A1. NOTE Sterilization processes should be validated and routinely controlled. 6.8 Biocompatibility The thermometer shall be free from biological hazard. SIST EN 12470-2:2001+A1:2009

EN 12470-2:2000+A1:2009 (E) 7 NOTE EN ISO 10993-1 should be used as guidance. 6.9 Measurement time (clinical) for preadjusted thermometers The manufacturer shall demonstrate and document that the specified measurement time conforms to the chosen offset by either: a) compilation and analysis of relevant scientific literature; or b) analysis of data obtained from the result of clinical investigation. 6.10 Additional requirements for multiple-use thermometers Thermometers for multiple use shall be designed to fulfil the requirements of this standard for at least the number of uses specified by the manufacturer after use, cleaning and regeneration as specified by the manufacturer.

Testing shall be performed in accordance with 7.7.

6.11 Mechanical safety The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be performed by visual inspection. 7 Test methods 7.1 General Each individual lot shall be subjected to testing, either individual or statistical. For statistical testing the lot shall be homogenous and thermometers from various sources shall not be mixed. The sampling plan shall correspond to ISO 2859-2:1985, level II with a limiting quality level LQ=5%. NOTE 1 Other sampling plans can be used if they are statistically equivalent. NOTE 2 For suggested types of testing see Annex A. 7.2 Test of compliance of the maximum permissible error 7.2.1 Apparatus 7.2.1.1 Reference thermometer, with an uncertainty in temperature reading not greater than ± 0,02 °C (coverage factor k=2) shall be used to determine the temperature of the water bath. I

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