Name: EN 12470-2:2000+A1:2009
Brand: CEN

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

Published date

06-17-2009

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Unit
5 Type 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 performance requirements and test methods for phase change-type (dot matrix) thermometers for measuring temperature in body cavities.NOTEA 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.

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	Current

Standards	Relationship
NEN EN 12470-2 : 2000 + A1 2009	Identical
I.S. EN 12470-2:2000	Identical
SN EN 12470-2 : 2001 + A1 2009	Identical
UNE-EN 12470-2:2001+A1:2009	Identical
NF EN 12470-2 : 2000 + A1 2009	Identical
DIN EN 12470-2:2009-11	Identical
NBN EN 12470-2 : 2001 + A1 2009	Identical
AS EN 12470.2-2004	Identical
NS EN 12470-2 : 2000 + A1 2009	Identical
PN EN 12470-2 : 2003 + A1 2010	Identical
UNI EN 12470-2 : 2009	Identical
BS EN 12470-2 : 2001	Identical
UNE-EN 12470-2:2001	Identical
BS EN 12470-2:2000+A1:2009	Identical

EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
ISO/IEC Guide 98:1993	Guide to the expression of uncertainty in measurement (GUM)
ISO 2859-2:1985	Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 980:2008	Symbols for use in the labelling of medical devices
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)