SIST EN 591:2002

Instructions for use for in vitro diagnostic instruments for professional use

This standard specifies the requirements for the contents of user manuals for in vitro diagnostic instruments including apparatus and equipment for professional use, hereafter called instruments. Note 1: User manuals are essential to enable the safe and proper operation of instruments. Note 2: This standard can also be applied to accessories. This standard is not applicable to field repair instructions.

Gebrauchsanweisungen für Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal

Diese Norm legt die Anforderungen an den Inhalt von Gebrauchsanweisungen für Geräte für in-vitro-diagnostische  Untersuchungen einschließlich Apparaten, Instrumenten, Kalibriermaterialien und Kontrollmaterialien, nachstehend IVD-Geräte genannt, zum Gebrauch durch Fachpersonal fest.
ANMERKUNG 1   Gebrauchsanweisungen sind erforderlich, um den sicheren und ordnungsgemäßen Betrieb von IVD-Geräten zu ermöglichen.
ANMERKUNG 2   Diese Norm kann auch für Zubehör angewendet werden.
Diese Norm ist nicht anwendbar auf Anweisungen für die Durchführung von Reparaturen.

Notices d'utilisation des instruments pour le diagnostic in vitro pour usage professionnel

1 Domaine d'application
La présente Norme européenne spécifie les exigences s'appliquant au contenu des notices d'utilisation pour les instruments de diagnostic in vitro incluant les appareils, les équipements, les calibrateurs et les matériaux de contrôle a usage professionnel, ci-dessous appelés instruments de DIV.
NOTE 1   Les notices d'utilisation sont essentielles pour permettre un usage correct et en toute sécurité des instruments de diagnostic in vitro.
NOTE 2   La présente norme peut également s'appliquer aux accessoires.
Elle ne s'applique pas aux instructions de réparation sur site.

Zahteve za priročnike za uporabnike diagnostičnih instrumentov in vitro za profesionalno uporabo

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2002
• Withdrawal Date: 19-Jan-2010
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 18-Jan-2010
• Due Date: 10-Feb-2010
• Completion Date: 20-Jan-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use

Relations

• Replaced By: SIST EN ISO 18113-3:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
• Effective Date: 01-Mar-2010
• Replaces: SIST EN 591:2000 - In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
• Effective Date: 01-May-2002

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 591:2002
01-maj-2002
1DGRPHãþD
SIST EN 591:2000
=DKWHYH]DSULURþQLNH]DXSRUDEQLNHGLDJQRVWLþQLKLQVWUXPHQWRYLQYLWUR]D
SURIHVLRQDOQRXSRUDER
Instructions for use for in vitro diagnostic instruments for professional use
Gebrauchsanweisungen für Geräte für in-vitro-diagnostische Untersuchungen zum
Gebrauch durch Fachpersonal
Notices d'utilisation des instruments pour le diagnostic in vitro pour usage professionnel
Ta slovenski standard je istoveten z: EN 591:2001
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 591:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

EUROPEAN STANDARD
EN 591
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2001
ICS 11.100 Supersedes EN 591:1994
English version
Instructions for use for in vitro diagnostic instruments for
professional use
Notices d'utilisation des instruments pour le diagnostic in Gebrauchsanweisungen für Geräte für in-vitro-
vitro pour usage professionnel diagnostische Untersuchungen zum Gebrauch durch
Fachpersonal
This European Standard was approved by CEN on 19 January 2001.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 591:2001 E
worldwide for CEN national Members.

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

Page 2
EN 591:2001
Foreword
This European Standard has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medical
devices", the secretariat of which is held by DIN.
The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by September 2001, and conflicting national standards shall be withdrawn at the latest
by September 2001.
This European Standard supersedes EN 591:1994.
This European Standard 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 standard.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.

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

Page 3
EN 591:2001
1 Scope
This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments
including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD
instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments.
NOTE 2 This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
ISO 1000, SI units and recommendations for the use of their multiples and of certain other units.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
calibrator
substance, material or article intended by its manufacturer to be used to establish the measurement relationships
of an in vitro diagnostic medical device [EN 375]
3.2
control material
substance, material or article intended by its manufacturer to be used to verify the performance characteristics of an
in vitro diagnostic medical device [EN 375]
3.3
instructions for use
information supplied by the manufacturer with an IVD instrument concerning the proper use and the safe and correct
operation, maintenance and basic trouble-shooting of the IVD instrument
3.4
internal quality control
operational techniques and activities at the point of use that are used to fulfil requirements for quality of services [EN
375]
NOTE Internal quality control comprises all steps of activity for production of results from collection of sample
and measurement of a measurable quantity to reporting of result of measurement.
3.5
in vitro diagnostic instrument
IVD instrument
in vitro diagnostic medical device which is an instrument, apparatus or equipment
NOTE 1 For the definition of an in vitro diagnostic medical device see [4].
NOTE 2 In some cases a particular IVD instrument, as defined for use in human medicine, may serve also
in veterinary medicine.
3.6
professional use
use by personnel who have received special education and training with regard to procedures utilizing in vitro
diagnostic medical devices [EN 375]

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

Page 4
EN 591:2001
3.7
specimen
biological material which is obtained in order to detect or to measure one or more quantities [EN 375]
4 Form and presentation of the instructions for use
The wording shall be readily understandable. The following shall be given, where appropriate:
a) overview of operating elements;
b) flow and block diagrams of instrument construction;
c) integration and arrangement of text/illustrations;
d) graphic emphasis of warnings;
e) examples;
f) diagrams of procedural steps;
g) relevant scientific literature.
5 Requirements for the content of the instructions for use
5.1 General
Instructions for use for IVD instruments shall contain the information given in 5.2 to 5.23. This information may be
supplied in different ways, e. g. as user manual, part of the built-in software of the instrument, audio or video
recording or other electronic means.
Instructions for use shall include a table of contents and an index.
Languages shall be used in accordance with the requirements of the country(ies) in which the IVD instrument is
distributed.
5.2 Graphical symbols
Any graphical symbols used on the IVD instrument shall be explained in the instructions for use, if no European or
International Standards exist to which the symbols used conform.
NOTE Any graphical symbols used on the IVD instrument should be explained and/or the relevant European
or International Standards should be given.
5.3 Manufacturer

The name and address of the manufacturer shall be given.

NOTE The manufacturer is the entity which has taken the legal responsibility for the IVD instrument.
The name and address of the authorized representative shall also be given when this is a legal requirement.
5.4 Identification
The name of the IVD instrument and/or separate instrument modules, including, where applicable, software shall be
given.
5.5 Storage and handling
Instructions relevant to any particular storage and/or handling conditions shall be given.

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

Page 5
EN 591:2001
5.6 Warnings and precautions

Any warnings and precautions shall be given relevant to:
a) any special, unusual risks related to installation, operation, maintenance, transportation, storage or disposal
of the IVD instrument;
NOTE Examples of such risks are those related to handling and disposal of infectious or potentially
infectious materials.
b) known interferences;
c) use not recommended by the man
...