SIST EN 592:2002

Instructions for use for in vitro diagnostic instruments for self-testing

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1   Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
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 zur Eigenanwendung

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

Notice d'utilisation des instruments de diagnostic in vitro pour usage comme auto-test

La présente Norme européenne spécifie les exigences relatives au contenu des notices d'utilisation des instruments de diagnostic in vitro, y compris les appareils et les équipements pour auto-test, qui sont désignés par le terme instruments DIV (pour diagnostic in vitro) dans la suite de ce document.
NOTE 1   La notice d'utilisation est primordiale pour permettre aux personnes non initiées de se servir des instruments DIV correctement et en toute sécurité.
NOTE 2   La présente norme peut également etre appliquée aux accessoires.
La présente norme n'est pas applicable aux instructions de réparation sur place.

Navodila za uporabo diagnostičnih instrumentov in vitro za samopreskušanje

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-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 592:2002 - Instructions for use for in vitro diagnostic instruments for self-testing

Relations

• Replaced By: SIST EN ISO 18113-5:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
• Effective Date: 01-Mar-2010
• Replaced By: SIST EN ISO 18113-5:2010 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 592:2000 - In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home use
• Effective Date: 01-Nov-2002

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 592:2002
01-november-2002
1DGRPHãþD
SIST EN 592:2000
1DYRGLOD]DXSRUDERGLDJQRVWLþQLKLQVWUXPHQWRYLQYLWUR]DVDPRSUHVNXãDQMH
Instructions for use for in vitro diagnostic instruments for self-testing
Gebrauchsanweisungen für Geräte für in-vitro-diagnostische Untersuchungen zur
Eigenanwendung
Notice d'utilisation des instruments de diagnostic in vitro pour usage comme auto-test
Ta slovenski standard je istoveten z: EN 592:2002
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 592:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN 592
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2002
ICS 11.100 Supersedes EN 592:1994
English version
Instructions for use for in vitro diagnostic instruments for self-
testing
Instructions d'utilisation d'instruments pour le diagnostic in Gebrauchsanweisungen für Geräte für in-vitro-
vitro pour usage comme auto-test diagnostische Untersuchungen zur Eigenanwendung
This European Standard was approved by CEN on 20 December 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, Malta, 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
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 592:2002 E
worldwide for CEN national Members.

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EN 592:2002 (E)
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 August 2002, and conflicting national standards shall be withdrawn at the
latest by August 2002.
This European Standard supersedes EN 592:1994.
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 EU Directive(s).
For relationship with EU 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, Malta, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and the United Kingdom.
1 Scope
This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic
instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1  Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
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 editions 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
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 [1].
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EN 592:2002 (E)
NOTE 2  In some cases a particular IVD instrument, as defined for use in human medicine, may serve also in veterinary
medicine.
[EN 591:2001]
3.2
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 [EN 591:2001]
3.3
lay person
individual who does not have specific medical education [EN 376:2002]
3.4
self-testing
use in the home or similar environments by a lay person who will relate the result of the test to him- or herself
[EN 376:2002]
3.5
specimen
biological material which is obtained in order to detect or to measure one or more quantities [EN 375:2001]
4 Form and presentation of the instructions for use
The wording shall be readily understood. Consideration shall be given to the following aspects of presentation,
where appropriate:
a) overview of operating elements;
b) flow and block diagrams;
c) integration and arrangement of text/illustrations;
d) graphic emphasis of warnings;
e) examples;
f) diagrams of procedural steps.
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 5.19. The information
provided shall be easy to read and well-organized. The print shall be easily legible and terms simple and not
unnecessarily technical or scientific. Symbols and illustrations shall be used wherever possible. A statement that
the instructions for use are to be read carefully shall be made.
Where appropriate, instructions for use shall include a table of contents and an index.
The language(s) used shall be (an) official Community language(s), legally acceptable in the country in which
3

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EN 592:2002 (E)
the IVD instrument is distributed; additional languages are optional, bearing in mind the needs of the
anticipated users.
5.2 Graphical symbols
Any graphical symbols used on the IVD instrument shall be explained in the instructions for use. There are,
however, certain well-understood symbols already in use which are recognised to be suitable without need for
further explanation, i. e. those symbols as so identified in EN 980.
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 components shall be provided.
5.5 Storage and handling
Instructions relevant to any particular storage and/or handling conditions shall be given.
5.6 Warnings and precautions
Any warnings and precautions relevant to any special, unusual risks related to installation, operation,
maintenance, transportation, storage or disposal of the IVD instrument shall be given.
5.7 Intended purpose
The intended purpose of the IVD instrument and the fact that it
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