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EN 12470-4:2000+A1:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

Superseded date

10-01-2012

Superseded by

EN ISO 80601-2-56:2017

Published date

06-17-2009

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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Unit
5 Types of thermometers
6 Requirements
7 Test methods
8 Information supplied by the manufacturer
Annex A (informative) - Suggested types of testing for the
                        requirements of this standard
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         93/42/EEC
Bibliography

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.NOTEDevices 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.

Committee
CEN/TC 205
DevelopmentNote
2000 Edition Re-Issued in June 2009 & incorporates AMD 1 2009. (08/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
IEC 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
EN 980:2008 Symbols for use in the labelling of medical devices
EN 60068-2-14:2009 Environmental testing - Part 2-14: Tests - Test N: Change of temperature
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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