EN 1060-2:1995/FprA1
(Amendment)Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
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
Relations
Overview
EN 1060-2:1995/FprA1 is the CEN draft amendment addressing supplementary requirements for mechanical non-invasive sphygmomanometers. Prepared by Technical Committee CEN/TC 205, this amendment updates references and specific marking and documentation obligations for mechanical blood pressure devices. The document is issued as a final draft (FprA1) and, while distributed for review, is subject to change until formally accepted and published.
This part of the EN 1060 series complements the general requirements in Part 1 and sits alongside Part 3 (electro-mechanical systems) and Part 4 (system accuracy test procedures) as part of the European framework for non-invasive blood pressure measurement devices.
Key Topics
- Reference updates: Clause 2 replaces the referenced standard for symbols with EN 980:2008, Symbols for use in the labelling of medical devices.
- Marking and labelling: Modifications to Clauses 9.2 and 9.3 clarify which items of Part 1 apply and add a specific marking requirement for mercury manometers: the symbol for "CAUTION" per EN 980:2008.
- Annex ZA (Regulatory link): The amendment replaces Annex ZA to define the relationship between EN 1060-2 and the Essential Requirements of Directive 93/42/EEC on medical devices, indicating which clauses provide a presumption of conformity with the Directive.
- Bibliography: The amendment adds a bibliography entry, notably EN 1041, Information supplied by the manufacturer of medical devices.
Applications
This amendment is relevant to:
- Manufacturers and designers of mechanical sphygmomanometers seeking to align products with current European labelling and regulatory mapping.
- Regulatory and conformity assessment teams assessing device compliance with Directive 93/42/EEC (medical devices) using referenced EN clauses.
- Technical writers and labeling specialists implementing EN 980 symbols and manufacturer information per EN 1041.
Practical benefits include clearer marking rules (important for user safety and risk reduction), an updated symbol reference to harmonized labelling practice, and explicit mapping to essential regulatory requirements that supports CE conformity assessments.
Related Standards
- EN 1060-1 - General requirements for non-invasive sphygmomanometers (referenced throughout).
- EN 1060-3 / EN 1060-4 - Complementary parts covering electro-mechanical systems and test procedures.
- EN 980:2008 - Symbols for labelling of medical devices (updated reference in this amendment).
- EN 1041 - Information supplied by the manufacturer of medical devices (added to bibliography).
Note: This draft amendment is distributed for review and shall not be regarded as the final European Standard until formally adopted. Always consult the latest published national implementation for definitive requirements.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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
...
Frequently Asked Questions
EN 1060-2:1995/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers". This standard covers: Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
EN 1060-2:1995/FprA1 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.
EN 1060-2:1995/FprA1 has the following relationships with other standards: It is inter standard links to EN 1060-2:1995+A1:2009, EN 1060-2:1995. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1060-2:1995/FprA1 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.
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