EN 12470-4:2000+A1:2009
(Main)Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
This part of EN 12470 specifies the metrological and technical requirements for electrical thermometers for continuous measurements.
This European Standard applies to devices that are operated by an electrical power supply either by mains or internal power sources.
The devices can be equipped to accommodate secondary indicators, printing devices, and other auxiliary devices. The metrological requirements for such accessories are not covered by this European Standard.
Thermometers intended to measure skin temperatures are not covered by this European Standard.
This European Standard does not intend to exclude the use of any device based on other measuring principles that provides an equivalent performance in continuously measuring body temperature.
NOTE Devices can have functions which are covered by different parts of EN 12470. In this case, it is the responsibility of the manufacturer to indicate by which part of EN 12470 the function is covered, e.g. electrical thermometer with maximum device and exchangeable temperature probes.
Medizinische Thermometer - Teil 4: Anforderungen an elektrische Thermometer zur kontinuierlichen Messung
Dieser Teil der EN 12470 legt die messtechnischen und sonstigen technischen Anforderungen an elektrische
Thermometer zur kontinuierlichen Messung fest.
Diese Europäische Norm gilt für Geräte, die durch eine elektrische Energiequelle, entweder durch das Netz
oder eine interne Stromversorgung, betrieben werden.
Die Geräte können mit sekundären Anzeigen, Druckern und anderen Hilfsvorrichtungen ausgestattet sein. Die
messtechnischen Anforderungen für derartiges Zubehör sind nicht in dieser Europäischen Norm enthalten.
Thermometer zur Messung der Hauttemperatur sind nicht in dieser Europäischen Norm enthalten.
In dieser Europäischen Norm ist nicht beabsichtigt, die Verwendung von Geräten auf der Grundlage anderer
Messprinzipien auszuschließen, vorausgesetzt, dass sie bei kontinuierlicher Messung der Körpertemperatur
eine gleichwertige Leistung erbringen.
ANMERKUNG Die Geräte können Funktionen beinhalten, die durch andere Teile der EN 12470 abgedeckt werden. In
diesem Fall ist der Hersteller dafür verantwortlich, anzugeben, durch welchen Teil der EN 12470 die Funktion abgedeckt
wird, z. B. medizinische Thermometer mit Maximumvorrichtung und austauschbaren Temperaturfühlern.
Thermomètres médicaux - Partie 4: Fonctionnement des thermomètres électriques de mesurage continu
La présente partie de l'EN 12470 spécifie les exigences métrologiques et techniques auxquelles doivent satisfaire les
thermomètres électriques conçus pour les mesurages en continu.
La présente Norme européenne s'applique aux dispositifs fonctionnant grâce à une alimentation électrique provenant
du secteur ou de sources électriques internes.
Ces dispositifs peuvent être équipés pour pouvoir recevoir des indicateurs auxiliaires, des dispositifs d'impression ou
tout autre dispositif auxiliaire. Les exigences métrologiques relatives aux accessoires de ce type ne sont pas traitées
dans la présente norme européenne.
Les thermomètres conçus pour mesurer la température de la peau ne sont pas traités dans la présente Norme
européenne.
La présente Norme européenne n'entend pas exclure l'utilisation de dispositifs basés sur d'autres principes
de mesurage s'ils sont dotés des mêmes performances en ce qui concerne le mesurage continu de la température
du corps.
NOTE Certains dispositifs peuvent assurer des fonctions traitées dans différentes parties de l’EN 12740. Il est de la
responsabilité du fabricant d'indiquer la ou les parties applicables de la norme ; c'est le cas, par exemple, pour les
thermomètres électriques avec dispositif à maximum et sonde de température interchangeable.
Klinični termometri - 4. del: Delovanje električnih termometrov za nepretrgano merjenje
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.PHUMHQMHMedizinische Thermometer - Teil 4: Anforderungen an elektrische Thermometer zur kontinuierlichen MessungThermomètres médicaux - Partie 4: Fonctionnement des thermomètres électriques de mesurage continuClinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12470-4:2000+A1:2009SIST EN 12470-4:2001+A1:2009en,fr,de01-oktober-2009SIST EN 12470-4:2001+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12470-4:2000+A1
June 2009 ICS 17.200.20 Supersedes EN 12470-4:2000English Version
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
Thermomètres médicaux - Partie 4: Fonctionnement des thermomètres électriques de mesurage continu
Medizinische Thermometer - Teil 4: Anforderungen an elektrische Thermometer zur kontinuierlichen Messung 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 12470-4:2000+A1:2009: ESIST EN 12470-4:2001+A1:2009
Suggested types of testing for the requirements of this standard . 15Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 17Bibliography . 19 SIST EN 12470-4:2001+A1:2009
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 12470-4:2001+A1:2009
continuously measuring electrical thermometer
device that continuously measures
and displays the temperature of the human body and consists of an indicating unit and a connected temperature probe
3.2
indicating unit
component of the thermometer that processes the output signal of the temperature sensor and displays the value of the temperature. 3.3
temperature probe
component of the thermometer which is used
to
establish body temperature and comprises a temperature sensor with associated parts including coverings, seals, inner leads and connecting plug(s) when necessary. 4 Unit The unit of temperature shall be the degree Celsius, symbol °C. 5 Types of thermometers Electrical thermometers for continuous measurements (complete thermometers) shall consist of an indicating unit and a temperature probe (which may or may not be exchangeable). 6 Requirements 6.1 General
If protective probe covers are recommended or supplied by the manufacturer, the thermometer together with the probe cover shall conform to the requirements specified in this standard. 6.2 Measuring Range The measuring range shall be at least 25 °C to 45 °C. Larger measuring ranges can be subdivided into several partial measuring ranges; however, the range from 25 °C to 45 °C shall be continuous. Testing shall be performed in accordance with 7.2. 6.3 Maximum permissible error The maximum permissible error of a complete thermometer shall be ± 0,2 °C in the temperature range from 25 °C to 45 °C. For the manufacturing of components of complete thermometers the following values apply within the temperature range 25 °C to 45 °C: a) indicating unit : ± 0,1 °C; b) temperature probe : ± 0,1 °C. For thermometers where the specified measuring range is greater than 25 °C to 45 °C, the maximum permissible error shall not be greater than twice the specified values for temperatures < 25 °C and > 45 °C.
Testing shall be performed in accordance with 7.2. SIST EN 12470-4:2001+A1:2009
When subjected to rapid temperature change the indicated temperature of the complete thermometer shall not differ from the reference temperature after 150 s by more than the maximum permissible error. Testing shall be performed in accordance with 7.3. 6.5 Environmental operating range The minimum environmental operating range of the complete thermometer shall be from + 10 °C to + 40°C and 30 % to 75 % relative humidity. When tested in accordance with 7.4 the thermometer shall comply with 6.3. 6.6 Effect of Storage When tested in accordance with 7.5 the complete thermometer shall comply with 6.3. 6.7 Humidity When tested in accordance with 7.6 the complete thermometer shall comply with 6.3. 6.8 Electromagnetic compatibility The complete thermometer shall comply with EN 60601-1-2. 6.9 General requirements for safety The complete thermometer shall comply with EN 60601-1. The applied part shall be according to EN 60601-1:1990 Type BF or for direct cardiac application of Type CF. 6.10 Additional requirements for the indicating unit 6.10.1 Digital increment The digital increment of the indicating unit shall be 0,1 °C or less. Testing shall be carried out by visual inspection. 6.10.2 Display Numerical values on the display shall be at least 4 mm high or optically magnified so as to appear that height and shall be visible and/or legible to an operator having a visual acuity (corrected if necessary) of at least 1,0 when the operator is located 1 m in front of the indicating unit at an illuminance of 215 lx. The indicating unit shall provide an update at least every 10 s. The thermometer shall provide a visual or audible signal when the measured value of temperature is not within its specified measuring range. For segment based displays, all segments shall be activated after power on for at least 2 s, where applicable. Testing shall be carried out by visual inspection. SIST EN 12470-4:2001+A1:2009
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