SIST EN 12470-1:2000/kprA1:2009
(Amendment)Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
Medizinische Thermometer - Teil 1: Mit metallischer Flüssigkeit gefüllte Glasthermometer mit Maximumvorrichtung
Thermomètres médicaux - Partie 1: Thermomètres à dilatation de liquide métallique dans une gaine de verre, avec dispositif à maximum
Klinični termometri - 1. del: Zaprti stekleni termometri s tekočimi kovinami
General Information
- Status
- Not Published
- Public Enquiry End Date
- 09-Apr-2009
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 98 - Abandoned project (Adopted Project)
- Start Date
- 27-Mar-2013
- Due Date
- 01-Apr-2013
- Completion Date
- 27-Mar-2013
Relations
- Consolidated By
SIST EN 12470-1:2000+A1:2009 - Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device - Effective Date
- 01-Oct-2009
- Effective Date
- 01-Apr-2009
Overview
EN 12470-1:2000/prA1 (CEN draft amendment A1, 2009) is a European standard for clinical thermometers - specifically metallic liquid‑in‑glass thermometers with a maximum device used to measure human body temperature. Prepared by CEN/TC 205, this amendment updates the original EN 12470‑1:2000 and aligns marking, instructions and regulatory relationship with the EU medical devices Directive 93/42/EEC.
Key topics and requirements
- Scope and device type: Applies to metallic liquid‑in‑glass clinical thermometers that include a maximum (maximum-reading) device for retaining peak temperature.
- Manufacturer documentation:
- The manufacturer shall state the date of issue or the latest revision of the instructions for use (modification to clause 8.1).
- Instructions for use must include the name and address of the authorised representative when the manufacturer does not have a registered place of business within the European Community (additions to clauses 8.2 and 8.3).
- Marking: Labelling requirements are expanded to include authorised representative details where applicable (modification to clause 8.2).
- Regulatory alignment (Annex ZA):
- The amendment replaces Annex ZA to define the relationship between the standard and Essential Requirements of EU Directive 93/42/EEC.
- When cited in the Official Journal and adopted nationally, compliance with specified clauses provides a presumption of conformity with corresponding Directive requirements (within the standard’s scope).
- Standard lifecycle: This document is a draft amendment distributed for review and subject to change; it is not (yet) the final published European Standard.
Practical applications and users
Who uses EN 12470‑1:
- Manufacturers and product designers of liquid‑in‑glass clinical thermometers for ensuring compliant labelling and instructions.
- Regulatory and conformity assessment bodies assessing medical device compliance with Directive 93/42/EEC (legacy directive).
- Procurement teams and hospital biomedical engineering groups specifying or accepting clinical thermometers for clinical use.
- Notified bodies and authorised representatives who ensure that documentation, marking and instructions meet European requirements.
Practical benefits:
- Provides a clear basis for meeting EU regulatory expectations and helps demonstrate conformity for market access in Europe.
- Ensures consistent, traceable instructions and marking that support safe use in clinical environments.
Related standards
EN 12470 series (clinical thermometers):
- Part 2: Phase change‑type (dot matrix) thermometers
- Part 3: Performance of compact electrical thermometers (with maximum device)
- Part 4: Performance of electrical thermometers for continuous measurement
- Part 5: Performance of infra‑red ear thermometers (with maximum device)
Keywords: EN 12470‑1, clinical thermometers, liquid‑in‑glass thermometers, maximum device, CEN, medical device standard, 93/42/EEC, marking requirements, authorised representative.
Frequently Asked Questions
SIST EN 12470-1:2000/kprA1:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device". This standard covers: Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
SIST EN 12470-1:2000/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 12470-1:2000/kprA1:2009 has the following relationships with other standards: It is inter standard links to SIST EN 12470-1:2000+A1:2009, SIST EN 12470-1:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 12470-1:2000/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 12470-1:2000/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 =DSUWLVWHNOHQLWHUPRPHWULVWHNRþLPLNRYLQDPL
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum
device
Medizinische Thermometer - Teil 1: Mit metallischer Flüssigkeit gefüllte Glasthermometer
mit Maximumvorrichtung
Thermomètres médicaux - Partie 1: Thermomètres à dilatation de liquide métallique dans
une gaine de verre, avec dispositif à maximum
Ta slovenski standard je istoveten z: EN 12470-1:2000/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 12470-1:2000
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 17.200.20
English Version
Clinical thermometers - Part 1: Metallic liquid-in-glass
thermometers with maximum device
Thermomètres médicaux - Partie 1: Thermomètres à Medizinische Thermometer - Teil 1: Mit metallischer
dilatation de liquide métallique dans une gaine de verre, Flüssigkeit gefüllte Glasthermometer mit
avec dispositif à maximum Maximumvorrichtung
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 12470-1:2000. 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 12470-1:2000/prA1:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
1 Modification to 8.1, General .4
2 Modification to 8.2, Marking .4
3 Modification to 8.3, Instructions for use.4
4 Modification to Annex ZA .4
Foreword
This document (EN 12470-1:2000/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 un
...
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