SIST EN 12470-4:2001/kprA1:2009
(Amendment)Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
Medizinische Thermometer - Teil 4: Anforderungen an elektrische Thermometer zur kontinuierlichen Messung
Thermomètres médicaux - Partie 4: Performances des thermomètres électriques de mesurage continu
Klinični termometri - 4. del: Delovanje električnih termometrov za nepretrgano merjenje
General Information
Relations
Overview
EN 12470-4:2000/prA1 is a CEN draft amendment to the European standard EN 12470-4 - “Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement.” This document applies to clinical electrical thermometers intended for continuous measurement of human body temperature. The 2009 prA1 amendment updates normative references, marking and labelling requirements, instructions for use, and the informative Annex ZA linking the standard to EU medical device legislation.
Key topics and requirements
- Scope and application
- Applies to clinical electrical thermometers used for continuous body-temperature monitoring.
- Part of the EN 12470 family covering different thermometer technologies (liquid-in-glass, phase-change, compact electrical, infra-red ear).
- Normative references
- Updates include referencing EN 60601-1:2006 (Medical electrical equipment - general safety and essential performance) and the retitling of EN 980 as “Symbols for use in the labelling of medical devices.”
- Marking and labelling
- Thermometers must display °C adjacent to numeric values if not shown on the display.
- Where the manufacturer has no registered place of business in the community, the name and address of the authorised representative must appear on the complete thermometer, temperature probe and indicating unit.
- Instructions for use
- Manufacturers must state the date of issue or latest revision of the instruction leaflet.
- Instructions must include the name and address of the authorised representative when applicable.
- Regulatory alignment
- Annex ZA maps clauses of the standard to the Essential Requirements of EU Directive 93/42/EEC (medical devices), supporting conformity assessment within the directive’s scope.
Practical applications and users
- Who uses this standard
- Medical device manufacturers and designers of continuous electrical thermometers.
- Notified bodies and conformity assessors performing CE marking evaluation.
- Clinical engineers, biomedical technicians and test laboratories verifying product labelling and compliance with safety/performance references.
- Procurement teams and hospital risk managers specifying compliant monitoring equipment.
- Why it matters
- Ensures consistent labelling, instructions and regulatory traceability, improving patient safety and facilitating market access in Europe.
- Links device performance and safety expectations to established electrical safety standards (EN 60601-1), streamlining compliance for medical electrical equipment.
Related standards
- EN 12470 (other parts): Part 1, Part 2, Part 3, Part 5
- EN 60601-1:2006 (medical electrical equipment - general requirements)
- EN 980 (labelling symbols)
Keywords: clinical thermometers, electrical thermometers, continuous measurement, EN 12470-4, CEN, medical device standard, EN 60601-1, labelling, instructions for use, EU Directive 93/42/EEC.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
.OLQLþQLWHUPRPHWULGHO 'HORYDQMHHOHNWULþQLKWHUPRPHWURY]DQHSUHWUJDQR
PHUMHQMH
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous
measurement
Medizinische Thermometer - Teil 4: Anforderungen an elektrische Thermometer zur
kontinuierlichen Messung
Thermomètres médicaux - Partie 4: Performances des thermomètres électriques de
mesurage continu
Ta slovenski standard je istoveten z: EN 12470-4:2000/prA1
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 12470-4:2000
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 17.200.20
English Version
Clinical thermometers - Part 4: Performance of electrical
thermometers for continuous measurement
Thermomètres médicaux - Partie 4: Fonctionnement des Medizinische Thermometer - Teil 4: Anforderungen an
thermomètres électriques de mesurage continu elektrische Thermometer zur kontinuierlichen Messung
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 12470-4:2000. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
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 Ref. No. EN 12470-4:2000/prA1:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
1 Modification to Clause 2, Normative references .4
2 Modification to 8.1, General .4
3 Modification to 8.2.1, Complete thermometer .4
4 Modification to 8.2.2, Temperature probe .4
5 Modification to 8.2.3, Indicating unit.4
6 Modification to 8.3, Instructions for use.5
7 Modification to Annex ZA .5
Foreword
This document (EN 12470-4:2000/prA1:2009) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
This European Standard applies to clinical thermometers which are used for meas
...
Frequently Asked Questions
SIST EN 12470-4:2001/kprA1:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement". This standard covers: Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
SIST EN 12470-4:2001/kprA1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 12470-4:2001/kprA1:2009 has the following relationships with other standards: It is inter standard links to SIST EN 12470-4:2001+A1:2009, SIST EN 12470-4:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 12470-4:2001/kprA1:2009 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 12470-4:2001/kprA1:2009 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.
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...