SIST EN 1060-1:2000/kprA2:2009

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
• Public Enquiry End Date: 14-Oct-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 1060-1:1995/FprA2 - Non-invasive sphygmomanometers - Part 1: General requirements

Relations

• Consolidated By: SIST EN 1060-1:2000+A2:2010 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 01-Mar-2010
• Amends: SIST EN 1060-1:2000 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 01-Sep-2009

Overview

EN 1060-1:1995/FprA2 is a CEN draft amendment addressing the general requirements for non-invasive sphygmomanometers (blood pressure measuring devices). Prepared by CEN/TC 205, this document updates references, clarifies manufacturer documentation and labelling obligations, and aligns the standard with the Essential Requirements of EU Directive 93/42/EEC (Medical Devices Directive) via Annex ZA.

This part (Part 1) is the foundational element of the EN 1060 series, which also includes:

• Part 2: Supplementary requirements for mechanical sphygmomanometers
• Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
• Part 4: Test procedures to determine overall system accuracy of automated devices

The FprA2 amendment specifically updates Clause 2 and Clauses 9.1–9.3 and replaces Annex ZA to clarify regulatory relationships.

Key Topics

• Scope and purpose: Establishes general safety and information requirements applicable to non-invasive sphygmomanometers as a baseline for the series.
• Documentation and instructions: Requires the manufacturer to state the date of issue or latest revision of the instruction for use, improving traceability of user information.
• Labelling: Updates references to harmonized symbol and information standards (EN 980 and EN 1041) and reinforces obligations for manufacturer identification on labels and documentation.
• Manufacturer and representative details: Mandates inclusion of the name and address of the manufacturer and, where applicable, the authorised representative if the manufacturer is not established in the Community.
• Annex ZA: Defines the correspondence between clauses of EN 1060-1 and the Essential Requirements of Directive 93/42/EEC, clarifying the presumption of conformity when implemented as a national standard.

Applications

This standard is intended for:

• Manufacturers developing or updating non-invasive sphygmomanometers to meet EU regulatory expectations.
• Regulatory affairs teams verifying device documentation and demonstrating conformity with the Medical Devices Directive.
• Procurement and clinical engineering departments requiring assurance that devices meet harmonized European requirements for safety and labelling.
• Test laboratories and conformity assessment bodies using Part 1 as the normative framework when applying Parts 2–4 for device-specific testing.

Benefits include clearer labelling requirements, improved user instructions, and a documented pathway to demonstrate presumption of conformity with EU MDD provisions.

Related Standards

• EN 980 - Symbols for use in the labelling of medical devices
• EN 1041 - Information supplied by the manufacturer of medical devices
• EN 1060-2, EN 1060-3, EN 1060-4 - Supplementary and test procedure parts of the series

For manufacturers and stakeholders, EN 1060-1:1995/FprA2 provides a practical, regulatory-aligned framework for assuring basic safety, traceability and information quality for non-invasive blood pressure measuring equipment.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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 requiremen
...