EN 591:2001
(Main)Instructions for use for in vitro diagnostic instruments for professional use
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 à 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2002
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SIST EN 591:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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
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
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
...
Frequently Asked Questions
EN 591:2001 is a standard published by the European Committee for Standardization (CEN). Its full title is "Instructions for use for in vitro diagnostic instruments for professional use". This standard covers: 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.
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.
EN 591:2001 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 591:2001 has the following relationships with other standards: It is inter standard links to EN 591:1994, EN ISO 18113-3:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 591:2001 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/252. 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.
You can purchase EN 591:2001 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
The EN 591:2001 standard provides a comprehensive framework for the development and content of user manuals pertaining to in vitro diagnostic instruments intended for professional use. The scope of this standard is crucial, as it delineates the essential components that must be included in user manuals to ensure that these instruments are utilized safely and effectively. One of the key strengths of EN 591:2001 is its detailed stipulations regarding the necessary information that must be conveyed in user manuals. By focusing on the needs of professional users, the standard emphasizes clarity and comprehensibility, allowing healthcare professionals to easily operate and maintain in vitro diagnostic instruments. This is vital, as the correct use of these instruments directly impacts patient safety and diagnostic accuracy. Moreover, the standard acknowledges the importance of including relevant instructions for accessories, thereby ensuring that every component related to the diagnostic instrument is covered comprehensively. This holistic approach enhances the overall usability of the instruments, minimizing the risk of errors during operation due to inadequate instructions. However, it is important to note that the standard does not extend its applicability to field repair instructions, which could be seen as a limitation. Nevertheless, the primary focus on user manuals allows for a concentrated effort in establishing best practices for the safe and effective usage of in vitro diagnostic instruments. The relevance of EN 591:2001 cannot be understated, especially in a field where precision is paramount. As the healthcare landscape evolves, the standard serves as a critical reference point for manufacturers and providers alike, ensuring that user manuals meet the necessary guidelines for professional use. Overall, EN 591:2001 represents a vital step in standardizing the documentation of in vitro diagnostic instruments, promoting enhanced safety, efficiency, and clarity within the sector.
Die Norm EN 591:2001 legt die Anforderungen an die Inhalte von Benutzerhandbüchern für in vitro-Diagnosetechniken fest, die für den professionellen Einsatz gedacht sind. Der Umfang dieser Norm ist entscheidend, da sie spezifische Richtlinien bietet, die eine sichere und ordnungsgemäße Bedienung der Instrumente gewährleisten. Die klare Strukturierung und die detaillierten Vorgaben zu den Benutzerhandbüchern sind eine der größten Stärken dieser Norm. Durch die Definition wesentlicher Inhalte, die in den Benutzerhandbüchern enthalten sein müssen, unterstützt die Norm Fachkräfte dabei, die Funktionsweise der Geräte zu verstehen und mögliche Risiken zu minimieren. Dies ist besonders relevant für den Einsatz in sensiblen Bereichen der medizinischen Diagnostik, wo Fehlbedienungen schwerwiegende Folgen haben könnten. Ein weiterer positiver Aspekt der EN 591:2001 ist ihre Anwendbarkeit auf Zubehörteile, was die Flexibilität und Relevanz der Norm erhöht. Diese vielseitige Anwendung erstreckt sich über die Benutzerhandbücher hinaus und umfasst auch alle Bestandteile, die im Zusammenhang mit in vitro-Diagnosetechniken stehen. Die Klarstellung, dass diese Norm nicht für Anleitungen zur Feldreparatur gilt, konzentriert die Anforderung auf das Wesentliche und verringert mögliche Missverständnisse. Insgesamt bietet die Norm EN 591:2001 eine wertvolle Grundlage für die Erstellung von Benutzerhandbüchern für in vitro-Diagnosetechniken und gewährleistet damit die Sicherheit und Effizienz im professionellen Einsatz dieser wichtigen Instrumente.
SIST EN 591:2002는 전문용으로 사용되는 체외 진단 기기의 사용자 매뉴얼에 대한 요구 사항을 명확히하는 표준입니다. 이 표준은 전문 기기와 장비의 안전하고 적절한 작동을 보장하기 위해 반드시 필요한 사용자 매뉴얼의 내용을 규정하고 있습니다. 사용자가 쉽게 이해할 수 있는 안내서가 제공됨으로써 기기를 올바르게 사용할 수 있는 기초를 마련합니다. 이 표준의 강점 중 하나는 사용자가 직면할 수 있는 다양한 상황에 대한 명확한 지침을 포함하고 있다는 점입니다. 이는 사용자로 하여금 기기를 안전하게 운영하는 데 필요한 정보를 체계적으로 접근할 수 있도록 도와줍니다. 또한, 이 표준은 기기의 부수적 장치에도 적용 가능하여, 전반적인 사용자 경험을 향상시키는 데 기여합니다. SIST EN 591:2002는 필드 수리 지침에는 적용되지 않는다는 점을 분명히 하여, 사용자 매뉴얼의 범위를 확실히 하고 있습니다. 이는 사용자가 매뉴얼의 목적과 한계를 이해하는 데 도움을 주며, 불필요한 혼란을 줄입니다. 결론적으로, 이 표준은 전문용 체외 진단 기기를 효과적으로 활용하기 위한 기초를 제공하며, 올바른 사용자 매뉴얼의 중요성을 강조하고 있습니다.
EN 591:2001は、プロフェッショナル用の体外診断機器に関するユーザーマニュアルの内容要件を定めた重要な標準です。この標準の範囲は、体外診断機器に関連する装置や機器を含むすべての器具に適用され、ユーザーマニュアルの重要性を強調しています。マニュアルは、器具の安全かつ適切な操作を確保するために不可欠であり、この標準はそれに必要な情報を具体的に示しています。 この標準の強みは、ユーザーマニュアルの構成要素を明確に定義し、使用者が理解しやすい形式で提供することにあります。また、付属品にも同様の原則が適用できる旨が記載されており、包括的なガイダンスを提供しています。さらに、フィールド修理に関する指示書には適用されない点も明示されており、マニュアル作成に際しての焦点が明確にされています。 EN 591:2001は、体外診断機器の安全性と操作性を高めるための基盤を提供するものであり、医療現場でのプロのユーザーにとって極めて関連性の高い標準です。この標準を遵守することで、医療機器の適切な使用が促進され、患者の安全も向上することが期待されます。
La norme EN 591:2001, intitulée "Instructions pour l'utilisation d'instruments de diagnostic in vitro à usage professionnel", constitue un document fondamental pour tout professionnel travaillant avec des instruments de diagnostic in vitro. Son champ d'application est clairement défini, soulignant les exigences relatives au contenu des manuels d'utilisation de ces instruments, essentiels pour garantir leur fonctionnement en toute sécurité et de manière appropriée. L'un des points forts de cette norme réside dans sa capacité à standardiser les informations fournies dans les manuels d'utilisation. En imposant des critères spécifiques sur le contenu, la norme EN 591:2001 permet de s'assurer que toutes les informations nécessaires sont disponibles, ce qui facilite la formation du personnel et réduit le risque d'erreurs lors de l'utilisation des instruments. De plus, cette norme inclut également des dispositions relatives aux accessoires, élargissant ainsi son application et renforçant son utilité dans un environnement clinique. La pertinence de la norme EN 591:2001 ne peut être sous-estimée, surtout dans un contexte où la rigueur et la fiabilité sont primordiales. En clarifiant les attentes concernant la documentation des instruments de diagnostic, cette norme répond directement aux besoins des professionnels de la santé qui doivent naviguer dans un paysage technologique en constante évolution. Enfin, il convient de noter que bien que la norme ne soit pas applicable aux instructions de réparation sur le terrain, son focus sur les manuels d'utilisation reste d'une importance capitale. En résumé, la norme EN 591:2001 se positionne comme un outil indispensable pour garantir le bon usage des instruments de diagnostic in vitro en milieu professionnel, consolidant ainsi la sécurité et l'efficacité des pratiques médicales.
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