SIST EN 12470-2:2001/kprA1:2009
(Amendment)Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
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
Relations
Overview
EN 12470-2:2000/prA1 is a CEN draft amendment addressing clinical thermometers - Part 2: Phase change type (dot matrix) thermometers. Prepared by Technical Committee CEN/TC 205 (Non‑active medical devices), this prA1 document proposes targeted modifications to the existing EN 12470-2:2000 standard. The standard applies to clinical thermometers used for measuring the body temperature of humans and sits within the EN 12470 family of medical thermometer standards.
Note: this document was circulated as a draft amendment for Unique Acceptance Procedure and, if approved, will amend the EN 12470-2:2000 text.
Key topics and requirements
The amendment/published draft focuses on administrative, labelling and instructions‑for‑use requirements as well as the Standard’s relationship with EU medical device law:
- Normative references
- Updates the title of EN 980 to: “Symbols for use in the labelling of medical devices.”
- Instructions for use
- Manufacturer must state the date of issue or latest revision of the instructions for use.
- Adds requirement to include the name and address of the authorised representative when the manufacturer does not have a registered place of business in the Community.
- Thermometer and primary packaging labelling
- Requires the authorised representative’s name/address to appear on the thermometer and on primary packaging where applicable.
- Annex ZA (informative)
- Replaces/updates the Annex ZA to map clauses of EN 12470-2 to the Essential Requirements of Directive 93/42/EEC (medical devices). This provides the presumption of conformity pathway when the standard is implemented nationally and cited in the Official Journal.
Practical applications and users
Who uses this standard and why:
- Manufacturers of phase change (dot matrix) clinical thermometers - for product labeling, packaging and instructions compliance.
- Regulatory affairs and quality teams - to demonstrate conformity with EU requirements and prepare technical documentation for CE marking.
- Notified bodies and conformity assessors - to assess whether devices meet the mapped Essential Requirements.
- Procurement and clinical engineering - to specify compliant devices.
- Standards bodies and test laboratories - for national adoption, testing scope and harmonization.
Related standards
- EN 12470 (series): Part 1 (liquid‑in‑glass), Part 3–5 (electrical, continuous, infra‑red ear).
- EN 980: Symbols for labelling medical devices (updated title referenced).
Keywords: EN 12470-2, clinical thermometers, phase change thermometers, dot matrix, CEN, medical device standard, instructions for use, labelling, Annex ZA, 93/42/EEC, authorised representative.
Frequently Asked Questions
SIST EN 12470-2:2001/kprA1:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers". This standard covers: Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
SIST EN 12470-2:2001/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 12470-2:2001/kprA1:2009 has the following relationships with other standards: It is inter standard links to SIST EN 12470-2:2001+A1:2009, SIST EN 12470-2:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 12470-2:2001/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 12470-2:2001/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.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
.OLQLþQLWHUPRPHWULGHO 7HUPRPHWULNL]D]QDYDMRVSUHPHPERID]H WRþNRYQD
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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