EN 12470-1:2000+A1:2009

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device

This Part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glass thermometers with maximum device and applies only to thermometers filled with metallic liquid.
NOTE 1   Note that in some European countries the use of mercury is prohibited in clinical thermometers.   
NOTE 2   Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No reference is made to these in this European standard because there is no experience of clinical thermometers which use other substances.
This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of this standard.

Medizinische Thermometer - Teil 1: Mit metallischer Flüssigkeit gefüllte Glasthermometer mit Maximumvorrichtung

Dieser Teil der EN 12470 legt Anforderungen und Prüfverfahren für medizinische Flüssigkeits-Glasthermometer
mit Maximumvorrichtung fest und gilt nur für Thermometer, die mit metallischen Flüssigkeiten gefüllt
sind.
ANMERKUNG 1 Es ist zu beachten, dass in einigen europäischen Ländern der Gebrauch von Quecksilber in
medizinischen Thermometern verboten ist.
ANMERKUNG 2 Es können auch andere Substanzen bei der Herstellung von Flüssigkeits-Glasthermometern verwendet
werden. In dieser Europäischen Norm wird auf diese kein Bezug genommen, da keine Erfahrungen mit medizinischen
Thermometern, die andere Substanzen verwenden, vorliegen.
Diese Europäische Norm gilt nicht für klinische Thermometer, die für spezifische Anwendungen (z. B.
Thermometer für Frühgeburten, Ovulationsthermometer) ausgelegt sind und die durch ihren Messbereich, ihre
Skalenteilung oder ihre Fehlergrenzen aus dem Anwendungsbereich dieser Norm fallen.

Thermomètres médicaux - Partie 1: Thermomètres à dilatation de liquide métallique dans une gaine de verre, avec dispositif à maximum

La présente partie de l’EN 12470 spécifie les exigences de performance et les méthodes d'essai relatives aux
thermomètres médicaux à dilatation de liquide dans une gaine de verre avec dispositif à maximum et s'applique
seulement aux thermomètres contenant un liquide métallique.
NOTE 1 L’utilisation du mercure dans les thermomètres médicaux est interdite dans certains pays européens.
NOTE 2 D'autres substances que les liquides métalliques peuvent être utilisées dans la fabrication des thermomètres
à dilatation de liquide dans une gaine de verre. Aucune référence n'est mentionnée sur ce point dans la présente
Norme européenne, car à ce jour, aucune expérimentation n'a été faite sur des thermomètres médicaux contenant
d'autres substances.
La présente norme européenne ne s'applique pas aux thermomètres médicaux conçus pour des applications
particulières (par exemple les thermomètres destinés aux bébés prématurés, les thermomètres d'ovulation), qui,
en raison de leur étendue de mesure, de leur graduation, ou de leur erreur maximale tolérée, n’entrent pas dans
le domaine d’application de la présente norme.

Klinični termometri - 1. del: Zaprti stekleni termometri s tekočimi kovinami

General Information

• Status: Published
• Publication Date: 16-Jun-2009
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 12 - Clinical thermometers
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 05-Jun-2023
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12470-1:2000+A1:2009 - Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device

Relations

• Merged From: EN 12470-1:2000 - Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
• Effective Date: 18-Jan-2023
• Merged From: EN 12470-1:2000/prA1 - Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
• Effective Date: 29-Apr-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Thermometer - Teil 1: Mit metallischer Flüssigkeit gefüllte Glasthermometer mit MaximumvorrichtungThermomètres médicaux - Partie 1: Thermomètres à dilatation de liquide métallique dans une gaine de verre, avec dispositif à maximumClinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12470-1:2000+A1:2009SIST EN 12470-1:2000+A1:2009en,fr,de01-oktober-2009SIST EN 12470-1:2000+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12470-1:2000+A1
June 2009 ICS 17.200.20 Supersedes EN 12470-1:2000English Version
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
Thermomètres médicaux - Partie 1: Thermomètres à dilatation de liquide métallique dans une gaine de verre, avec dispositif à maximum
Medizinische Thermometer - Teil 1: Mit metallischer Flüssigkeit gefüllte Glasthermometer 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 12470-1:2000+A1:2009: ESIST EN 12470-1:2000+A1:2009

Suggested types of testing for the requirements of this standard . 16Annex B (informative)
Advice to be considered for inclusion in the instruction leaflet accompanying mercury-in-glass thermometers . 18Annex C (informative)
Bibliography . 19Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 20Annex ZB (informative)
A-deviations . 23 SIST EN 12470-1:2000+A1:2009

For A-deviations, see annex ZB. 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, C, ZA and ZB 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 12470-1:2000+A1:2009

NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No reference is made to these in this European standard because there is no experience of clinical thermometers which use other substances. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of 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. EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices ISO 719, Glass - Hydrolytic resistance of glass grains at 98 degrees C - Method of test and classification 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 correction value added algebraically to the uncorrected result of a measurement to compensate for systematic error 3.2 error result of measurement minus a true value of the measurand 3.3 maximum device device which prevents the liquid column from falling when the temperature of the liquid in the bulb returns to the ambient temperature 3.4 scale panel (enclosed-scale type) panel to which the scale is fixed longitudinally behind the capillary tube 3.5 stabilized thermometer reading SIST EN 12470-1:2000+A1:2009

The scale marks and numbers shall be at right angles to the axis of the thermometer and shall be visible at the same time as the liquid column. Testing shall be performed by visual inspection. 6.1.2.2 Scale spacing The distance between adjacent scale marks shall be at least 0,5 mm for solid-stem thermometers and at least 0,6 mm for enclosed-scale thermometers. Testing shall be performed using an appropriate device, which magnifies the scale by at least x 4. SIST EN 12470-1:2000+A1:2009

6.1.2.3 Width and length of the scale marks The scale marks shall be durably marked and shall be of uniform width not exceeding one-quarter of the length of a scale spacing plus 0,05 mm for solid-stem thermometers, or one-fifth of the length of a scale spacing plus 0,05 mm for enclosed-scale thermometers. Scale marks representing whole degrees and half degrees shall be longer than the other scale marks. Testing shall be performed using an appropriate device, which magnifies the scale by at least x 4. 6.1.2.4 Numbering Scale marks representing whole degrees shall be numbered. NOTE The scale mark representing the temperature of 37 ûC can be rendered conspicuous by means of a different colour from that used for the numbering and/or by additional marking. Testing shall be performed by visual inspection. 6.1.2.5 Special requirements for solid-stem thermometers The scale shall be indelibly marked directly on the thick-walled capillary stem. When tested in accordance with 7.2, the appearance of the scale lines shall not be significantly affected. 6.1.2.6 Special requirements for enclosed-scale thermometers The thermometer shall have a separate scale panel adjacent to the capillary tube. The capillary tube and the scale panel shall be enclosed in a transparent tube impermeably fixed to the bulb and forming a protection sheath. The scale shall be marked on a scale panel fixed longitudinally behind the capillary tube. Testing shall be performed by visual inspection. 6.1.2.7 Resistance to breakage of enclosed-scale thermometers The thermometer shall not break when subjected to a force of at least 50N in accordance with 7.8. 6.2 Material 6.2.1 Thermometer bulb 6.2.1.1 General The thermometer bulb shall be made of a type of glass which satisfies the requirements specified in 6.2.1.2 and 6.2.1.3. This glass shall be clearly and indelibly identified by either: a) an integral mark introduced by the glass manufacturer in such a way as to be clearly recognizable on the bulb after manufacture of the thermometer or; b) by a mark chosen by the glass manufacturer and affixed by the thermometer manufacturer and clearly indicating the type of glass used. SIST EN 12470-1:2000+A1:2009

6.3.2 Capillary tube The capillary tube shall ensure that the entire length of the liquid column and the meniscus are c
...