SIST EN 12470-3:2000+A1:2009
(Main)Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
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 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 thermometers intended to measure skin temperature.
Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung
Dieser Teil von EN 12470 legt die Leistungsanforderungen für medizinische elektrische (extrapolierende und
nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung fest.
Diese Europäische Norm gilt für Geräte, die während der Temperaturmessung durch eine interne Stromquelle
versorgt werden und eine digitale Temperaturanzeige liefern.
Diese Europäische Norm gilt nicht für elektrische medizinische Thermometer zur kontinuierlichen Messung
und für Thermometer zur Messung der Hauttemperatur.
Thermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif maximum
La présente partie de l'EN 12470 spécifie les exigences de performance relatives aux thermomètres médicaux
électriques compacts avec dispositif à maximum (à comparaison et à extrapolation).
La présente norme européenne s'applique aux dispositifs qui, lors du mesurage des températures, sont alimentés
par une source d'énergie interne, et qui donnent une indication numérique de la température.
La présente norme européenne ne s'applique pas aux thermomètres médicaux électriques de mesurage continu ni
aux thermomètres destinés à mesurer la température de la peau.
Klinični termometri - 3. del: Delovanje zaprtih trdnih električnih termometrov (brez umerjanja ali z njim)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit MaximumvorrichtungThermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif maximumClinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12470-3:2000+A1:2009SIST EN 12470-3:2000+A1:2009en,fr,de01-oktober-2009SIST EN 12470-3:2000+A1:2009SLOVENSKI
STANDARD
SIST EN 12470-3:2000+A1:2009
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12470-3:2000+A1
June 2009 ICS 17.200.20 Supersedes EN 12470-3:2000English Version
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
Thermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif à maximum
Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer 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 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 12470-3:2000+A1:2009: ESIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Unit .55Types of thermometers .56Performance requirements .57Test methods .88Information supplied by the manufacturer . 14Annex A (informative)
Suggested types of testing for the requirements of this standard . 16Annex B (informative)
Bibliography . 18Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 19 SIST 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 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 12470-3:2000. 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 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 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 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 12470-3:2000+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 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 thermometers 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 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. EN 980, !Symbols for use in the labelling of medical devices" 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 (IEC 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 (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 thermometer device which calculates the maximum temperature of a probe in contact with a body cavity, without waiting for thermal equilibrium to occur, by heat transfer data and a mathematical algorithm and maintains the calculated maximum temperature value for a specified time or until reset by its user 3.3 compact non-predictive thermometer device with a part or function of the thermometer that monitors over a required period of time the temperature measured by a temperature probe in contact with a body cavity after which it indicates and maintains the maximum temperature value for a specified time or until reset by its user SIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 5 3.4 indicating unit component of the thermometer that processes the output signal of the temperature sensor and displays the value of the temperature 3.5 maximum device part or function of the thermometer which stores and indicates the numerical value of the maximum temperature 3.6 temperature probe component of the thermometer, part of which is applied to a body cavity and establishes temperature. It comprises a temperature sensor with associated parts including coverings, seals, and inner leads when necessary NOTE A body cavity can be the mouth, rectum, armpit or naso-pharynx. 4 Unit The unit of temperature shall be the degree Celsius, symbol °C. 5 Types of thermometers The types of compact clinical electrical thermometers with maximum device shall be: a) non-predictive thermometers; b) predictive thermometers. 6 Performance requirements 6.1 Probe cover If protective probe covers are recommended or supplied by the manufacturer, the thermometer together with the probe cover shall meet the requirements specified in this standard. !If the probe cover is a single use device, it shall bear an indication on the probe cover or on its packaging, which is consistent across the European Community, that it is intended for single use only." 6.2 Metrological requirements 6.2.1 Measuring range The thermometer shall cover the minimum measuring range from 35,5 °C to 42,0 °C. The thermometer shall provide a visual or auditory warning when the measured value of temperature is not within its specified measuring range. Testing shall be carried out in accordance with 7.2. SIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 6 6.2.2 Digital increment The digital increment of the indicating unit shall be 0,1 °C or less. Testing shall be performed by visual inspection. 6.2.3 Maximum permissible error under reference conditions The maximum permissible error for the measuring range 35,5 °C to 42,0 °C shall be 0,1 °C within the ambient temperature range from 18 °C to 28 °C. Outside the measuring range of 35,5 °C to 42,0 °C or outside the ambient temperature range, the maximum permissible error shall not be greater than twice the specified value. Testing shall be in accordance with 7.3. For predictive and non-predictive thermometers with an offset, the manufacturer shall provide information on: a) data obtained from the result of a clinical investigation; NOTE For this investigation predictive thermometers can be modified by incorporating a switch to allow operation alternatively in predictive and non-predictive mode. In the non-predictive mode the thermometer should meet the requirements of 6.2.3 when tested according to 7.2. In this case the thermometer is tested in the predictive mode and read, then the mode is switched to non-predictive and the temperature is read again after achieving thermal equilibrium. The two temperature readings should not differ by more than 0,2 °C for more than 98% of the subjects. In the case that the thermometer to be investigated cannot be modified accordingly, it should be compared against a calibrated clinical reference thermometer, preferably at the same body site. Selection of test persons should be in accordance with the intended use of the thermometer. The clinical test should be performed in accordance with Annex X of the Medical Device Directive (MDD). b) the procedure for testing in a water bath. 6.2.4 Time response When a non-predictive thermometer at a temperature of (23 ± 2) °C is immersed into a water bath at (37 ± 1) °C for 60 s the indicated temperature shall not differ from the reference temperature by more than the maximum permissible error. Testing shall be performed in accordance with 7.4. 6.2.5 Maximum energy dissipation The indicating unit shall provide an energizing potential sufficiently low so that the energy dissipation (I2R) in the probe shall not cause an increase in indicated temperature by more than 0,01 °C when the probe is immersed in a reference water bath at (37 ± 0,1) °C. Testing shall be performed in accordance with 7.5. 6.2.6 Long term stability The long term stability of the thermometer, after exposing it for a minimum of 288 h to a temperature of (55 ± 2) °C, or for a minimum of 96 h to a temperature of (80 ± 2) °C, shall be such that the values for maximum permissible errors specified in 6.2.3 are met. SIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 7 Testing shall be performed in accordance with 7.6. 6.3 Environmental requirements 6.3.1 Ambient operating range The minimum ambient operating range of the thermometer shall be from + 10 °C to + 35 °C. When tested in accordance with 7.7, the thermometer shall comply with 6.2.3. 6.3.2 Effect of storage When tested in accordance with 7.8, the thermometer shall comply with 6.2.3. 6.3.3 Thermal shock When tested in accordance with 7.9, the thermometer shall comply with 6.2.3. 6.3.4 Humidity When tested in accordance with 7.10, the thermometer shall comply with 6.2.3. 6.3.5 Electromagnetic compatibility The thermometer shall comply with EN 60601-1-2. 6.3.6 Mechanical shock When tested in accordance with 7.11, thermometers with a housing of plastic or metal shall comply with 6.2.3. 6.3.7 Water resistance When tested in accordance with 7.12, the thermometer shall comply with 6.2.3. 6.4 Construction requirements 6.4.1 Functional units 6.4.1.1 Voltage limit indication The thermometer shall automatically provide a visual or auditory warning when its supply voltage is not within specified limits and shall meet the maximum permissible errors in 6.2.3 when the voltage is within these specified limits. Testing shall be performed in accordance with 7.13. 6.4.1.2 Indicating unit Numerical values on the display shall be at least 4 mm high or optically magnified so as to appear that height. After power-on all segments shall be activated for at least 1 s. Testing shall be performed by visual inspection. SIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 8 6.4.1.3 Functional safe test The thermometer shall have a self-testing routine. The correct operation shall be indicated by a given display. The manufacturer shall provide information as to how the self-testing routine operates and what display is to be expected. 6.4.2 Material The thermometer shall be free from biological hazards. NOTE See EN ISO 10993-1 for the selection of appropriate test methods. 6.5 Electrical safety The thermometer shall comply with EN 60601-1. 6.6 Mechanical safety 6.6.1 Thermometer Thermometers shall not have sharp ends or angles that could injure the user or patient. The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be performed by visual and tactile inspection. 6.6.2 Resistance to breakage A thermometer with a housing of glass shall comply with 6.1.2.7 of prEN 12470-1: 1998. 7 Test methods 7.1 General 7.1.1 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 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. SIST EN 12470-3:2000+A1:2009
EN 12470-3:2000+A1:2009 (E) 9 7.2 Method for the determination of the measuring range 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. Its calibration shall be tr
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