SIST EN 1060-2:2000/kprA1:2009

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: Not Harmonized2007/47/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:

  ---

  Not Harmonized93/42/EEC - 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

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

Overview

SIST EN 1060-2:2000/kprA1:2009 specifies the supplementary requirements for mechanical non-invasive sphygmomanometers-devices used to measure blood pressure without penetrating the skin. Developed by the Slovenian Institute for Standardization (SIST) in alignment with European norms, this amendment supports the harmonization of medical device standards with the essential safety and performance requirements of EU Directive 93/42/EEC for medical devices.

Its focus is on mechanical blood pressure measuring devices such as aneroid or mercury sphygmomanometers. By meeting the requirements outlined here, manufacturers ensure safer, more reliable products and facilitate market access across Europe.

Key Topics

The standard addresses several critical subjects to enhance the safe and effective use of mechanical non-invasive sphygmomanometers:

• Labeling and Marking: Updated to reference EN 980:2008, ensuring consistent use of symbols for medical device labeling, including mandatory caution markers for mercury instruments.
• Supplementary Technical Requirements: Additional specifications build upon the general requirements from EN 1060-1, ensuring mechanical devices meet rigorous accuracy and reliability standards.
• Harmonization with EU Legislation: Direct correspondence between standard clauses and the essential requirements stipulated in EU Directive 93/42/EEC, ensuring legal compliance.
• Enhanced Documentation: Requirements for information supplied by manufacturers, supporting safe and proper use as outlined in EN 1041.
• Modification and Interpretation Guidance: Updates and clarifications to previous clauses align with evolving safety standards and regulatory expectations.

Applications

This standard applies to a broad spectrum of stakeholders in the medical device sector:

• Manufacturers: Provides a clear framework for designing, labeling, and documenting mechanical sphygmomanometers. Compliance enables smoother certification processes under the Medical Devices Directive, streamlining access to both national and European markets.
• Regulatory Authorities: Offers a reference point for device conformity assessments, facilitating approvals and market surveillance.
• Healthcare Institutions and Professionals: Assures that non-invasive sphygmomanometers being procured are compliant with the latest European safety and performance requirements, supporting better patient safety.
• Notified Bodies and Testing Laboratories: Supplies criteria for testing, inspection, and conformity assessment services related to mechanical blood pressure devices.

By following SIST EN 1060-2:2000/kprA1:2009, organizations ensure that their mechanical blood pressure measurement devices offer consistent results, safe operation, and user-friendly labeling, which leads to improved patient care and user confidence.

Related Standards

For comprehensive conformity and market readiness, the following standards and guidance documents work in conjunction with SIST EN 1060-2:

• EN 1060-1: General requirements for non-invasive sphygmomanometers
• EN 1060-3: Supplementary requirements for electro-mechanical blood pressure measuring systems
• EN 1060-4: Test procedures for system accuracy of automated non-invasive sphygmomanometers
• EN 980:2008: Symbols for use in the labeling of medical devices
• EN 1041: Information supplied by the manufacturer of medical devices
• EU Directive 93/42/EEC: Essential requirements and compliance framework for medical devices in the European Union

Practical Value

Adhering to SIST EN 1060-2:2000/kprA1:2009 ensures that mechanical non-invasive sphygmomanometers meet high standards for accuracy, labeling consistency, and regulatory compliance. This standard is vital for enabling international market access, reducing risk of regulatory non-compliance, and protecting patient safety in clinical practice. It is recommended for all organizations involved in the design, production, procurement, or regulation of non-invasive blood pressure monitors.

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
...