SIST EN 12470-2:2001+A1:2009
(Main)Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
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
Relations
Overview
EN 12470-2:2000+A1:2009 is a CEN (European) standard that defines performance requirements and test methods for clinical phase-change (dot matrix) thermometers used to measure human body temperature in body cavities (mouth, rectum, axilla). It applies to single‑use and multiple‑use dot-matrix thermometers and sets requirements for scale, accuracy, retention, regeneration, storage effects and safety. This Part is one of several in the EN 12470 family covering clinical thermometers.
Key topics and technical requirements
- Measuring ranges and scale: Short-scale (35.5–40.4 °C) and long-scale (minimum 35.5–42.0 °C) options; scale interval no greater than 0.1 °C; numerals at each degree mark.
- Temperature indication: Distinct visible change (dot state/colour) when dots activate.
- Retention time: Readings must remain legible for at least 20 s after removal and equilibration at room temperature.
- Adjacent dot activation: The temperature step to activate adjacent dots is limited (test uses 0.2 °C increments).
- Skipped dots: No two adjacent skipped dots; total skipped dots ≤ 5% of all dots.
- Regeneration: Thermometers must be returnable to functional condition by a manufacturer‑specified regeneration method.
- Storage and environmental robustness: Standard defines cyclic storage tests (high/low temperature and humidity cycles) and subsequent verification against performance criteria.
- Multiple‑use durability: Multiple‑use thermometers must meet performance after the number of reuses claimed by the manufacturer, including cleaning and regeneration procedures.
- Safety & labelling: Probe geometry for mechanical safety; biocompatibility guidance (EN ISO 10993‑1); sterilization labelling reference (EN 556+A1); information supplied per EN 1041 and symbol rules per EN 980.
- Test methods: Uses traceable reference thermometers, controlled water baths, and sampling plans (ISO 2859‑2) for lot testing; includes detailed immersion and measurement procedures.
Applications and who uses this standard
- Thermometer manufacturers: design, type‑approval, production quality control and declaration of measurement performance.
- Test laboratories and notified bodies: performance verification, lot testing and compliance testing against CEN requirements.
- Healthcare procurement and clinicians: selecting devices that meet European performance and safety expectations for oral, rectal or axillary use.
- Regulatory affairs and quality managers: demonstrating conformity with EU medical device directives (see informative Annex ZA).
Related standards
- EN 12470 series (Parts 1, 3, 4, 5) - other clinical thermometer types
- EN 1041 - information supplied by the manufacturer
- EN 980 - symbols for labelling medical devices
- EN 556+A1 - sterilization labelling requirements
- ISO 2859‑2 - sampling plans for lot inspection
This standard is essential when evaluating or certifying phase‑change (dot matrix) clinical thermometers under European requirements (EN 12470‑2).
Frequently Asked Questions
SIST EN 12470-2:2001+A1:2009 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers". This standard covers: 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.
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.
SIST EN 12470-2:2001+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.
SIST EN 12470-2:2001+A1:2009 has the following relationships with other standards: It is inter standard links to SIST EN 12470-2:2001/kprA1:2009, SIST EN 12470-2:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 12470-2:2001+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.
You can purchase SIST EN 12470-2:2001+A1:2009 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
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
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
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
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
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
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
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...