EN ISO 18113-5:2011
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2009)
Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung fest.
Dieser Teil von ISO 18113 gilt auch für Geräte und Ausrüstungen, die für den Gebrauch von Geräten für in vitro diagnostische Untersuchungen zur Eigenanwendung vorgesehen sind.
Dieser Teil von ISO 18113 kann auch auf Zubehör angewendet werden.
Der vorliegende Teil von ISO 18113 gilt nicht für:
a) Anweisungen für die Geräteinstandhaltung oder reparatur;
b) IVD Reagenzien, einschließlich Kalibriermittel und Kontrollmaterialien zur Kontrolle des Reagenz; oder
c) IVD Instrumente zum Gebrauch durch Fachpersonal.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-5:2009)
L'ISO 18113-5:2009 spécifie les exigences relatives aux informations fournies par le fabricant d'instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 s'applique aussi aux appareillages et aux équipements destinés à être utilisés avec les instruments de DIV pour auto-tests.
L'ISO 18113-5:2009 peut aussi s'appliquer aux accessoires, le cas échéant.
Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 5. del: Diagnostični instrumenti in vitro za samopreskušanje (ISO 18113-5:2009)
Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih instrumentov in vitro za samopreskušanje. Ta del ISO 18113 velja tudi za aparate in opremo, ki se uporabljajo z diagnostičnimi instrumenti in vitro za samopreskušanje. Ta del ISO 18113 lahko velja tudi za dodatno opremo. Ta del ISO 18113 ne velja za a) navodila za servisiranje ali popravilo instrumentov; b) diagnostične reagente in vitro, vključno s kalibratorji in kontrolnimi materiali, ki se uporabljajo pri nadzoru reagenta; c) diagnostične instrumente in vitro za poklicno uporabo.
General Information
Relations
Frequently Asked Questions
EN ISO 18113-5:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)". This standard covers: ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.
EN ISO 18113-5:2011 is classified under the following ICS (International Classification for Standards) categories: 11.100.10 - In vitro diagnostic test systems. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 18113-5:2011 has the following relationships with other standards: It is inter standard links to EN ISO 18113-5:2009, EN ISO 18113-5:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 18113-5:2011 is associated with the following European legislation: EU Directives/Regulations: 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 ISO 18113-5:2011 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.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
1DGRPHãþD
SIST EN ISO 18113-5:2010
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHSURL]YDMDOFD R]QDþHYDQMH
GHO 'LDJQRVWLþQLLQVWUXPHQWLLQYLWUR]DVDPRSUHVNXãDQMH ,62
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)
- Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 5:
Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-
5:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant
(étiquetage) - Partie 5: Instruments de diagnostic in vitro pour auto-tests (ISO 18113-
5:2009)
Ta slovenski standard je istoveten z: EN ISO 18113-5:2011
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 ISO 18113-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2011
ICS 11.100.10 Supersedes EN ISO 18113-5:2009
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer (labelling) - Part 5: In vitro diagnostic instruments
for self-testing (ISO 18113-5:2009)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant (étiquetage) - Partie 5: Instruments durch den Hersteller - Teil 5: Geräte für in-vitro-
de diagnostic in vitro pour auto-tests (ISO 18113-5:2009) diagnostische Untersuchungen zur Eigenanwendung (ISO
18113-5:2009)
This European Standard was approved by CEN on 20 September 2011.
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 CEN-CENELEC 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 CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18113-5:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” .4
Foreword
This document (EN ISO 18113-5:2011) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
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 April 2012, and conflicting national standards shall be withdrawn at the
latest by October 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18113-5:2009.
This new edition contains a revised Annex ZA.
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 EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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.
Endorsement notice
The text of ISO 18113-5:2009 has been approved by CEN as EN ISO 18113-5:2011 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic
Medical Devices”
This European Standard has been prepared under a mandate given to CEN by the European Commission to
provide a means of conforming to the Essential Requirements of the New Approach Directive 98/79/EC on “in
vitro Diagnostic Medical Devices”.
Once this European Standard is cited in the Official Journal of the European Union under that Directive and
has been implemented as national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this European Standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this European Standard and European Directive 98/79/EC
Clauses of this European Essential Requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes
These clauses only cover the
second sentence of ER B.7,
namely the labelling
6, 7.3, 7.11 B.7
requirements.
NOTE 2
7.12 B.7.2
Presumption of conformity with
ER B.8.1 also requires
compliance with clauses 4.1,
5, 6, 7 B.8.1
4.2.1 and 4.6 of EN ISO 18113-1.
5.2.1 B.8.4(b)
Full compliance to ER B.8.4(d)
requires the use of EN 980,
5.2.2 B.8.4(d) clause 5.4 symbol (LOT) or
EN 980, clause 5.5 symbol
(SN), as applicable.
5.2.3 B.8.4(g)
7.3 B.8.5
Presumption of conformity with
ER B.8.7(a) requires also
compliance with clause 4.5 of
6, 7.1, 7.2, 7.3, 7.4, 7.5, 7.11 B.8.7(a) EN ISO 18113-1.
NOTE 1,
NOTE 2
7.8 B.8.7(d)
7.2.2, 7.10 B.8.7(e)
7.10 B.8.7(f)
NOTE 2
7.11, 7.14, 7.15 B.8.7(g)
NOTE 2
7.7, 7.8, 7.9, 7.10, 7.11 B.8.7(h)
7.18 B.8.7(j)
7.12, 7.14 B.8.7(k)
Clauses of this European Essential Requirements Qualifying
Standard (ERs) of Directive 98/79/EC comments/Notes
7.6, 7.10 B.8.7(m)
7.6, 7.10, 7.14, 7.16, 7.17 B.8.7(n)
7.10 B.8.7(o)
NOTE 2
7.5, 7.16 B.8.7(s)
7.7, 7.12, 7.13, 7.14, 7.18,
B.8.7(t)
7.19
NOTE 1 In the European Union, the name and address of the manufacturer’s “EC Authorized representative” is
required on the outer container label or in the instructions for use, if the legal manufacturer is not located within the
European Union.
NOTE 2 Essential Requirement B.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of the
information required.
INTERNATIONAL ISO
STANDARD 18113-5
First edition
2009-12-15
In vitro diagnostic medical devices —
Information supplied by the manufacturer
(labelling) —
Part 5:
In vitro diagnostic instruments for self-
testing
Dispositifs médicaux de diagnostic in vitro — Informations fournies par
le fabricant (étiquetage) —
Partie 5: Instruments de diagnostic in vitro pour auto-tests
Reference number
ISO 18113-5:2009(E)
©
ISO 2009
ISO 18113-5:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 18113-5:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Essential requirements.2
5 Labels and marking.2
5.1 General .2
5.2 Identification of the IVD instrument.2
6 Elements of the instructions for use .3
7 Content of the instructions for use .3
7.1 Manufacturer.3
7.2 Identification of the IVD instrument.3
7.3 Intended use .4
7.4 Storage and handling.4
7.5 Warnings and precautions .4
7.6 Instrument installation.4
7.7 Principles of measurement .5
7.8 Performance of the IVD instrument .5
7.9 Limitations of use.5
7.10 Preparation prior to operation .5
7.11 Operating procedure .5
7.12 Control procedure .6
7.13 Reading of examination results .6
7.14 Special functions.6
7.15 Shut-down procedure .6
7.16 Disposal information.6
7.17 Maintenance.7
7.18 Troubleshooting .7
7.19 Follow-up action.7
Bibliography.8
ISO 18113-5:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 18
...
The EN ISO 18113-5:2011 standard outlines crucial specifications for the information that manufacturers must provide regarding in vitro diagnostic (IVD) instruments intended for self-testing. This standard is vital as it not only addresses labeling requirements but also extends its scope to apparatus and equipment associated with the IVD instruments, as well as accessories that may be utilized in conjunction with these devices. One of the notable strengths of the EN ISO 18113-5:2011 standard is its comprehensive approach to the labeling of IVD instruments for self-testing. By establishing clear requirements, this standard ensures that users receive appropriate and sufficient information concerning the use, safety, and effectiveness of these diagnostic devices. This is particularly crucial given the increasing shift towards self-testing in healthcare, empowering patients to monitor their health independently. The standard also emphasizes the importance of clarity and comprehensibility in the information provided. This aspect is essential for fostering user confidence in self-testing devices, mitigating the likelihood of misuse, and ensuring accurate interpretation of results. Moreover, the standard's relevance extends to regulatory compliance, assisting manufacturers in aligning their products with international best practices, thus simplifying the market entry process for IVD instruments in diverse regions. Furthermore, the EN ISO 18113-5:2011 standard includes provisions that account for the varying levels of user expertise, which is beneficial when considering a broad demographic of end-users. The inclusion of requirements for labeling accessories further enhances its applicability, ensuring that all components associated with the IVD instruments for self-testing are adequately documented and user-friendly. Overall, the EN ISO 18113-5:2011 standard is a cornerstone document that supports the safe and effective use of in vitro diagnostic instruments for self-testing. Its thorough requirements reinforce the importance of providing clear, accurate, and useful information from manufacturers to users, thereby enhancing the reliability of self-testing health solutions.
Die Norm EN ISO 18113-5:2011 legt spezifische Anforderungen an die Informationen fest, die von Herstellern in vitro diagnostischer (IVD) Instrumente für Selbsttests bereitgestellt werden müssen. Sie zielt darauf ab, sicherzustellen, dass Anwender von Selbsttest-Diagnosetools umfassend und verständlich informiert werden. Ein zentraler Aspekt dieser Norm ist die Benutzerfreundlichkeit der bereitgestellten Informationen, die entscheidend für die korrekte Anwendung der IVD-Geräte ist. Ein herausragendes Merkmal der Norm ist die klare Strukturierung und Standardisierung der Etikettierung und Gebrauchsanweisungen. Dies ermöglicht nicht nur eine einfache Handhabung für den Endverbraucher, sondern reduziert auch das Risiko von Fehlanwendungen, die für die Diagnose entscheidend sein könnten. Zudem wird empfohlen, dass alle notwendigen Angaben zur sicheren und effektiven Nutzung der Instrumente klar und deutlich kommuniziert werden. Die Relevanz dieser Norm erstreckt sich auch auf Zubehör und Apparate, die in Verbindung mit IVD-Instrumenten für Selbsttests verwendet werden. Dies sorgt für eine ganzheitliche Betrachtung des Produkts und stellt sicher, dass alle relevanten Informationen bereitgestellt werden, unabhängig davon, ob es sich um das Hauptinstrument oder die unterstützenden Gerätschaften handelt. Zusammengefasst bietet die EN ISO 18113-5:2011 eine wichtige Grundlage für Hersteller, um sicherzustellen, dass die Informationen, die sie ihren Kunden bereitstellen, den erforderlichen Standards entsprechen. Die Norm fördert nicht nur die Sicherheit und Effizienz im Umgang mit in vitro diagnostischen Instrumenten für Selbsttests, sondern trägt auch zur Erhöhung des Vertrauens der Verbraucher in diese medizinischen Geräte bei.
La norme EN ISO 18113-5:2011 joue un rôle crucial dans le domaine des dispositifs médicaux de diagnostic in vitro, en se concentrant spécifiquement sur les exigences relatives aux informations fournies par le fabricant pour les instruments de diagnostic in vitro destinés à l'autotest. Cette norme offre un cadre clair et structuré qui garantit que les utilisateurs finaux reçoivent des informations précises et pertinentes concernant l'utilisation, la sécurité et la performance de ces dispositifs. Les points forts de la norme EN ISO 18113-5:2011 résident dans sa capacité à s'appliquer non seulement aux instruments de diagnostic in vitro pour l'autotest, mais également aux appareils et équipements compatibles qui entourent ces instruments. Cela inclut une variété d'accessoires, ce qui élargit considérablement le champ d'application de la norme. Ce niveau d'inclusivité permet de s'assurer que tous les composants nécessaires au bon fonctionnement de l'autotest sont couverts par des directives standardisées, renforçant ainsi la sécurité et l'efficacité des produits sur le marché. En outre, l'importance de la norme EN ISO 18113-5:2011 est accentuée par sa pertinence dans le contexte actuel où l'autotest devient de plus en plus courant, notamment dans des situations de santé publique où un accès rapide aux diagnostics est essentiel. La norme assure que les informations fournies sont non seulement conformes aux exigences réglementaires, mais qu'elles sont également adaptées aux besoins des utilisateurs, facilitant ainsi une meilleure compréhension et une utilisation correcte des dispositifs de diagnostic. En résumé, la norme EN ISO 18113-5:2011 s'affirme comme un outil indispensable dans l'arsenal des fabricants d'instruments de diagnostic in vitro, garantissant une information cohérente, sûre et accessible pour les utilisateurs d'autotests, tout en intégrant les accessoires et équipements qui complètent ces dispositifs.
ISO 18113-5:2009는 자가 검사용 체외 진단(IVD) 의료 기기의 제조자가 제공하는 정보에 대한 요구 사항을 세부적으로 규정합니다. 이 표준은 자가 검사 목적으로 사용되는 IVD 기기뿐만 아니라, 해당 기기와 함께 사용될 수 있는 장치 및 장비에도 적용됩니다. 이러한 포괄적인 적용 범위는 표준이 다양한 기기와 접근ory에 대해 효력을 발휘할 수 있음을 보여 줍니다. ISO 18113-5:2009의 강점 중 하나는 제조자가 사용자가 이해하기 쉬운 정보를 제공하도록 요구한다는 점입니다. 이는 특히 의료 기기를 자가 검사용으로 사용하는 일반 소비자에게 매우 중요한 요소로, 사용자가 제품을 안전하고 효과적으로 사용할 수 있도록 돕습니다. 또한, 표준은 정보의 정확성과 명확성을 보장하여 제품의 신뢰성을 높이는 데 기여합니다. 또한 이 표준은 소비자와 제조자 간의 소통을 향상시키는 데 중요한 역할을 합니다. 자가 검사용 IVD 기기의 사용이 증가하는 시대에서, 이 표준은 사용자 경험을 개선하고, 제품에 대한 이해도를 높이며, 결과적으로 소비자 신뢰를 구축하는 데 기여할 수 있습니다. 결론적으로, ISO 18113-5:2009는 자가 검사용 체외 진단 의료 기기에 대한 정보 제공 요구 사항을 규정하여, 안전하고 효율적인 사용을 위한 기반을 마련하는 중요한 표준입니다. 이 표준의 채택은 제조업체가 소비자와 보다 효과적으로 소통하고, 제품의 신뢰성을 높이는데 도움을 줄 수 있습니다.
ISO 18113-5:2009は、自己検査用の体外診断（IVD）機器に関する製造者から提供される情報の要件を定めており、重要な指針となる標準です。この基準は、自己検査用IVD機器に関連する機器やデバイスにも適用されるため、幅広い範囲を網羅しています。また、付属品にも適用できるため、製造者が提供する全ての関連情報の透明性を確保するための強力な手段となっています。 この標準の強みは、IVD機器の安全性と効果的な使用を促進することにあります。ユーザーが情報を容易に理解できるようにデザインされており、品質が求められる医療機器に対する信頼を高める役割を果たします。具体的には、ラベリングの明確さや情報の整合性が求められ、これによって消費者が適切に機器を使用するための指導が行われます。 さらに、ISO 18113-5:2009は、自己検査用IVD機器の規制要件に準拠しているため、市場での競争力を高めるだけでなく、製造者が法令を遵守するための強力な基準として機能します。このように、ISO 18113-5:2009は、ユーザー、製造者、および規制当局にとって非常に関連性の高い標準であり、体外診断の分野における重要な要素を提供しています。
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