SIST EN 1060-2:2000/kprA1:2009

Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

Nichtinvasive Blutdruckmeßgeräte - Teil 2: Ergänzende Anforderungen für mechanische Blutdruckmeßgeräte

Tensiomètres non invasifs - Partie 2: Exigences complémentaires concernant les tensiomètres mécaniques

Neinvazivni sfigmomanometri - 2. del: Dodatne zahteve za mehanske sfigmomanometre TC: Neinvazivni sfigmomanometri - 2. del: Dodatne zahteve za neavtomatizirane sfigmomanometre

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Aug-2009
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 15-Mar-2013
• Due Date: 20-Mar-2013
• Completion Date: 15-Mar-2013
• 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: EN 1060-2:1995/FprA1 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers

Relations

• Amends: SIST EN 1060-2:2000 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
• Effective Date: 01-Jul-2009
• Consolidated By: SIST EN 1060-2:2000+A1:2010 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
• Effective Date: 18-Jan-2023
• Consolidated By: SIST EN 1060-2:2000+A1:2010 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
• Effective Date: 19-Jan-2023
• Consolidated By: SIST EN 1060-2:2000+A1:2010 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
• Effective Date: 01-Mar-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1060-2:2000/kprA1:2009
01-julij-2009
Neinvazivni sfigmomanometri - 2. del: Dodatne zahteve za mehanske
sfigmomanometre
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical
sphygmomanometers
Nichtinvasive Blutdruckmeßgeräte - Teil 2: Ergänzende Anforderungen für mechanische
Blutdruckmeßgeräte
Tensiomètres non invasifs - Partie 2: Exigences complémentaires concernant les
tensiomètres mécaniques
Ta slovenski standard je istoveten z: EN 1060-2:1995/FprA1
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 1060-2:2000/kprA1:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 1060-2:2000/kprA1:2009

---------------------- Page: 2 ----------------------

SIST EN 1060-2:2000/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 1060-2:1995
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
April 2009
ICS 11.040.55

English Version
Non-invasive sphygmomanometers - Part 2: Supplementary
requirements for mechanical sphygmomanometers
Tensiomètres non invasifs - Partie 2: Exigences Nichtinvasive Blutdruckmeßgeräte - Teil 2: Ergänzende
complémentaires concernant les tensiomètres mécaniques Anforderungen für mechanische Blutdruckmeßgeräte
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 1060-2:1995. 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 1060-2:1995/FprA1:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 1060-2:2000/kprA1:2009
EN 1060-2:2002/FprA1:2009 (E)
Contents Page
Foreword .3
1 Modification to Clause 2 .4
2 Modification to 9.2 .4
3 Modification to 9.3 .4
4 Modification to Annex ZA .4
5 Addition of Bibliography .8

2

---------------------- Page: 4 ----------------------

SIST EN 1060-2:2000/kprA1:2009
EN 1060-2:2002/FprA1:2009 (E)
Foreword
This document (EN 1060-2:2002/FprA1:2009) 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

---------------------- Page: 5 ----------------------

SIST EN 1060-2:2000/kprA1:2009
EN 1060-2:2002/FprA1:2009 (E)
1 Modification to Clause 2
Replace the reference to EN 980 with the following, and delete the accompanying footnote:
"EN 980:2008, Symbols for use in the labelling of medical devices".
2 Modification to 9.2
Replace the first sentence with the following:
"Items a), b), c) and e) of 9.2 of EN 1060-1:1995 shall apply with the following addition:".
3 Modification to 9.3
9.3 Marking of the device
Replace the first sentence and a) with the following:
"9.3 of EN 1060-1:1995 shall apply with the following addition only required for mercury manometers:
a) symbol for “CAUTION” according to 5.11 of EN 980:2008;".
4 Modification to Annex ZA
Replace the existing Annex ZA with the following:
"
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepa
...