EN 12470-2:2000+A1:2009
Current
The latest, up-to-date edition.
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
17-06-2009
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 |
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