EN 12470-4:2000+A1:2009
(Main + Amendment)Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
General Information
- Abstract
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.
- Status
- Withdrawn
- Publication Date
- 16-Jun-2009
- Withdrawal Date
- 16-Oct-2012
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 12 - Clinical thermometers
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 17-Oct-2012
- Completion Date
- 17-Oct-2012
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 293 OJ Date: 02-Dec-2009
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 18-Jan-2023
- Effective Date
- 18-Jan-2012
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Frequently Asked Questions
EN 12470-4:2000+A1:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement". This standard covers: 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.
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.
EN 12470-4:2000+A1:2009 is classified under the following ICS (International Classification for Standards) categories: 17.200.20 - Temperature-measuring instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12470-4:2000+A1:2009 has the following relationships with other standards: It is inter standard links to EN 12470-4:2000, EN 12470-4:2000/prA1, EN ISO 80601-2-56:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12470-4:2000+A1:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12470-4:2000+A1:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
The temperature probe shall be smoothly rounded in order to prevent tissue damage during use. Testing shall be carried out by visual and tactile inspection.
7 Test methods 7.1 General Each individual lot shall undergo either individual or statistical testing. 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 Testing for compliance with 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. Its calibration shall be traceable to national measurement standards. NOTE The definition of the coverage factor “k” is found in the “Guide to the expression of uncertainty in measurement”. SIST EN 12470-4:2001+A1:2009
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