SIST EN 1060-3:2000/kprA2:2009
(Amendment)Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Nichtinvasive Blutdruckmeßgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische Blutdruckmeßsysteme
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za elektromehanske sisteme za merjenje krvnega tlaka
General Information
Relations
Overview
EN 1060-3:1997/FprA2 is a draft amendment to the European standard covering supplementary requirements for electro-mechanical non-invasive sphygmomanometers (blood pressure measuring systems). Prepared by CEN/TC 205 and issued as a final draft in April 2009, this amendment updates normative references and specific clauses to align these devices with modern medical electrical equipment standards.
This document is part of the EN 1060 series, which includes:
- Part 1: General requirements
- Part 2: Supplementary requirements for mechanical sphygmomanometers
- Part 3: Supplementary requirements for electro-mechanical systems (this standard)
- Part 4: Test procedures to determine overall system accuracy of automated non-invasive sphygmomanometers
It is submitted under the Unique Acceptance Procedure and supports essential requirements of EC Directive 93/42/EEC on medical devices.
Key Topics
- Updated normative references: Replaces older references to EN 60601-1:1990 and EN 60601-1-2:1993 with current references (EN 60601-1:2006 and EN 60601-1-2) and adds EN 60601-1-8 for alarm systems. The reference to EN 475 is removed.
- Clause modifications: The amendment modifies specific clauses (for example 7.5.3, 7.7.2, 7.10 and 9.2) to ensure consistency with current medical electrical equipment requirements, including legibility and EMC provisions.
- Annex ZA update: Replaces Annex ZA to clarify the relationship between this standard and the Essential Requirements of Directive 93/42/EEC, listing which clauses confer a presumption of conformity when the standard is cited in the Official Journal.
Applications
This amendment is relevant to manufacturers, testing laboratories, conformity assessors, and regulatory teams involved with:
- Development and certification of automated/non-invasive blood pressure monitors
- Integration of alarm systems and electromagnetic compatibility (EMC) measures in clinical devices
- Demonstrating conformity with the Essential Requirements of Directive 93/42/EEC
Practical benefits include:
- Clearer alignment with current medical electrical safety and EMC standards
- Guidance on legibility and alarm requirements to improve usability and safety
- A route to a presumption of conformity with EU medical device requirements when the standard is implemented
Related Standards
- EN 60601-1:2006 - Medical electrical equipment: general safety and essential performance
- EN 60601-1-2 - Electromagnetic compatibility for medical electrical equipment
- EN 60601-1-8 - Alarm systems in medical electrical equipment
- Other parts of EN 1060 (Parts 1, 2 and 4) for general requirements, mechanical devices, and accuracy test procedures
For manufacturers and compliance teams, EN 1060-3:1997/FprA2 is a focused resource to ensure electro-mechanical sphygmomanometers meet updated electrical safety, EMC and alarm expectations while supporting regulatory conformity in the EU.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za elektromehanske
sisteme za merjenje krvnega tlaka
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
Nichtinvasive Blutdruckmeßgeräte - Teil 3: Ergänzende Anforderungen für
elektromechanische Blutdruckmeßsysteme
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les
systèmes électromécaniques de mesure de la pression sanguine
Ta slovenski standard je istoveten z: EN 1060-3:1997/FprA2
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 1060-3:1997
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA2
April 2009
ICS 11.040.55
English Version
Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring
systems
Tensiomètres non invasifs - Partie 3: Exigences Nichtinvasive Blutdruckmeßgeräte - Teil 3: Ergänzende
complémentaires concernant les systèmes Anforderungen für elektromechanische
électromécaniques de mesure de la pression sanguine Blutdruckmeßsysteme
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 1060-3:1997. 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 1060-3:1997/FprA2:2009: E
worldwide for CEN national Members.
EN 1060-3:2005/FprA2:2009 (E)
Contents Page
Foreword .3
1 Modifications to Clause 2 .4
2 Modification to Clause 3 .4
3 Modification to 7.5.3 .4
4 Modification to 7.7.2 .4
5 Modification to 7.10 .4
6 Modification to 9.2 .4
7 Modification to Annex ZA .4
EN 1060-3:2005/FprA2:2009 (E)
Foreword
This document (EN 1060-3:2005/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
...
Frequently Asked Questions
SIST EN 1060-3:2000/kprA2:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems". This standard covers: Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
SIST EN 1060-3:2000/kprA2:2009 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 1060-3:2000/kprA2:2009 has the following relationships with other standards: It is inter standard links to SIST EN 1060-3:2000+A2:2010, SIST EN 1060-3:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 1060-3:2000/kprA2:2009 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.
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