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
- 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
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 18-Jan-2023
- Effective Date
- 18-Jan-2012
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.
You can purchase EN 12470-4:2000+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 CEN standards.
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
...
The EN 12470-4:2000+A1:2009 standard presents a comprehensive framework focused on the performance requirements for electrical thermometers used in continuous measurement of body temperature. The scope of this standard is specifically tailored to devices powered by electricity, ensuring that they meet designated metrological and technical specifications for accurate temperature readings. One of the strengths of this standard is its clear definition of the types of devices it applies to, which includes those using mains or internal power sources. This precision ensures that manufacturers can align their products with recognized performance standards, enhancing the reliability and trustworthiness of thermometers in clinical settings. The inclusion of provisions for devices equipped with secondary indicators and other auxiliary tools demonstrates a forward-thinking approach, acknowledging the evolving needs of modern medical practice. The standard also emphasizes the importance of auxiliary devices, while noting that the metrological requirements for such accessories are not within its purview. This delineation aids manufacturers in understanding the boundaries of the standard, fostering compliance with the specific metrological requirements outlined. Furthermore, the acknowledgment that other measuring principles may provide equivalent performance for continuously measuring body temperature indicates an inclusive attitude towards innovation and technology in medical thermometry. This adaptability is vital in a landscape where diverse methodologies can coexist, thereby encouraging the development of a broader range of testing methods for body temperature assessment. While the standard explicitly excludes thermometers intended for measuring skin temperatures and does not cover the performance of devices based on different measuring principles, this clarification helps avoid misunderstandings and misapplications among users and manufacturers alike. It is crucial for manufacturers to specify which parts of the EN 12470 series apply to their devices, ensuring clarity and compliance. Overall, the EN 12470-4:2000+A1:2009 standard serves as a critical benchmark in the realm of clinical thermometers. Its specific focus on metrological and technical requirements, along with its adaptability to advancing technologies, makes it highly relevant in ensuring accurate and consistent body temperature measurement in clinical environments.
EN 12470-4:2000+A1:2009は、継続的な測定のための電気式体温計に関する規格であり、メトロロジーおよび技術的要件を具体化しています。この規格の適用範囲は、主に電力供給によって動作するデバイスに関するもので、主電源や内部電源を利用している製品が含まれます。 この規格の強みは、電気式体温計の性能を統一的に評価するためのガイドラインを提供することにあります。これにより、メーカーは製品の品質と信頼性を確保でき、医療機関や消費者に対しても安心感を与えることができます。また、二次指標や印刷デバイス、他の補助装置を装備可能なデバイスについても言及していますが、そのメトロロジー要件は別の規格によって扱われるため、専門的な情報整理が必要です。 しかし、皮膚温度を測定するための体温計はこの規格の適用外であり、また他の測定原理に基づくデバイスでも、継続的な測定で同等の性能を提供する場合は排除されないことが示されています。これにより、市場において多様な体温測定器が存在可能となり、使用者のニーズに応じた選択肢が広がることが期待されます。 さらに、この規格は、特定の機能がEN 12470の他の部分でカバーされている場合、製造者がその旨を明示する責任を持つことも強調しており、製品の透明性と専門性を促進します。全体として、EN 12470-4:2000+A1:2009は、電気式体温計の信頼性と品質を保証するための重要な枠組みを提供しており、医療分野における安全基準の向上に寄与するものです。
SIST EN 12470-4:2001+A1:2009 표준은 지속적인 측정을 위한 전기 온도계의 성능에 대해 정의하고 있으며, 메트로로지와 기술적 요구사항을 명확하게 규정합니다. 이 표준은 전원 공급 장치에 의해 작동되는 장비에 적용되며, 이는 일반 전원 또는 내부 전원 소스를 포함합니다. 이 표준의 강점 중 하나는 전기 온도계가 보조 지시기, 인쇄 장치 및 기타 보조 장치와 함께 사용될 수 있도록 설계된 점입니다. 그러나, 이러한 보조 장치에 대한 메트로로지 요구사항은 포함되지 않음을 분명히 하고 있습니다. 또한 피부 온도를 측정하기 위한 온도계는 이 표준의 적용 범위에서 제외되며, 이는 사용자가 특정한 용도에 맞는 장비를 선택할 수 있도록 돕습니다. SIST EN 12470-4:2001+A1:2009는 지속적으로 체온을 측정하는 장치에 대한 필수적인 성능 기준을 제공하며, 이는 병원 및 의료 환경에서의 신뢰성 있는 체온 측정을 보장합니다. 이 표준은 다른 측정 원리를 기반으로 하는 장치도 동등한 성능을 제공할 수 있음을 인정하고, 제조사가 해당 기능이 EN 12470의 어떤 부분에 포함되는지를 명기할 책임이 있다는 점에서, 사용자와 제조사 모두에게 중요한 정보를 제공합니다. 따라서 이 표준은 전기 온도계의 지속적인 측정을 위한 성능 요구 사항을 명확히 하고, 의료 장비에서 필수적으로 요구되는 안전성과 신뢰성을 높이는 데 크게 기여합니다. 이러한 점에서 SIST EN 12470-4:2001+A1:2009는 의료 기기 분야에서 매우 중요한 표준이라고 할 수 있습니다.
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