EN 12470-2:2000/prA1

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

Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix)

Thermomètres médicaux - Partie 2: Thermomètres à changement de phase (matrice à points)

Klinični termometri - 2. del: Termometri, ki zaznavajo spremembo faze (točkovna matrica)

General Information

• Status: Not Published
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 12 - Clinical thermometers
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 15-Apr-2009
• Completion Date: 15-Apr-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12470-2:2001/kprA1:2009 - Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

Relations

• Merged Into: EN 12470-2:2000+A1:2009 - Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
• Effective Date: 19-Jan-2023
• Amends: EN 12470-2:2000 - Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2009
.OLQLþQLWHUPRPHWULGHO7HUPRPHWULNL]D]QDYDMRVSUHPHPERID]HWRþNRYQD
PDWULFD
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
Medizinische Thermometer - Teil 2: Phasenumschlagthermometer (Punktmatrix)
Thermomètres médicaux - Partie 2: Thermomètres à changement de phase (matrice à
points)
Ta slovenski standard je istoveten z: EN 12470-2:2000/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 12470-2:2000
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 17.200.20
English Version
Clinical thermometers - Part 2: Phase change type (dot matrix)
thermometers
Thermomètres médicaux - Partie 2: Thermomètres à Medizinische Thermometer - Teil 2:
changement de phase (matrice à points) Phasenumschlagthermometer (Punktmatrix)
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 12470-2:2000. 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 12470-2:2000/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, Thermometer .4
4 Modification to 8.2.2, Primary package .4
5 Modification to 8.3, Instructions for use.4
6 Modification to Annex ZA .4

Foreword
This document (EN 12470-2:2000/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
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