EN 1060-1:1995/FprA2

Non-invasive sphygmomanometers - Part 1: General requirements

Nichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine Anforderungen

Tensiomètres non invasifs - Partie 1: Exigences générales

Neinvazivni sfigmomanometri - 1. del: Splošne zahteve

General Information

• Status: Not Published
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 10 - Non-invasive sphygmomanometers
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 14-Oct-2009
• Completion Date: 14-Oct-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 1060-1:2000/kprA2:2009 - Non-invasive sphygmomanometers - Part 1: General requirements

Relations

• Merged Into: EN 1060-1:1995+A2:2009 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 18-Jan-2023
• Amends: EN 1060-1:1995 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1060-1:2000/kprA2:2009
01-september-2009
Neinvazivni sfigmomanometri - 1. del: Splošne zahteve
Non-invasive sphygmomanometers - Part 1: General requirements
Nichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine Anforderungen
Tensiomètres non invasifs - Partie 1: Exigences générales
Ta slovenski standard je istoveten z: EN 1060-1:1995/FprA2
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 1060-1:2000/kprA2:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1060-1:2000/kprA2:2009

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SIST EN 1060-1:2000/kprA2:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 1060-1:1995
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA2
May 2009
ICS 11.040.55

English Version
Non-invasive sphygmomanometers - Part 1: General
requirements
Tensiomètres non invasifs - Partie 1: Exigences générales Nichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine
Anforderungen
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 A2, if approved, will modify the European Standard EN 1060-1:1995. 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 1060-1:1995/FprA2:2009: E
worldwide for CEN national Members.

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SIST EN 1060-1:2000/kprA2:2009
EN 1060-1:1995/FprA2:2009 (E)
Contents Page
Foreword .3
1 Modifications to Clause 2 .4
2 Modification to 9.1 .4
3 Modification to 9.2 .4
4 Modification to 9.3 .4
5 Modifications to Annex ZA .4

2

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SIST EN 1060-1:2000/kprA2:2009
EN 1060-1:1995/FprA2:2009 (E)
Foreword
This document (EN 1060-1:1995/FprA2:2009) 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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
This European Standard ‘Non-invasive sphygmomanometers’ consists of the following parts:
Part 1: General requirements
Part 2: Supplementary requirements for mechanical sphygmomanometers
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Part 4: Test procedures to determine the overall system accuracy of automated non-invasive
sphygmomanometers
3

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SIST EN 1060-1:2000/kprA2:2009
EN 1060-1:1995/FprA2:2009 (E)
1 Modifications to Clause 2
Replace the reference to "EN 980" with the f
...