SIST EN ISO 18113-5:2012
(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
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
...
Frequently Asked Questions
SIST EN ISO 18113-5:2012 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN ISO 18113-5:2012 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.
SIST EN ISO 18113-5:2012 has the following relationships with other standards: It is inter standard links to SIST EN ISO 18113-5:2010, SIST EN ISO 18113-5:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 18113-5:2012 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 SIST EN ISO 18113-5:2012 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 SIST standards.
La norme SIST EN ISO 18113-5:2012 établit des exigences précises concernant l'information fournie par le fabricant pour les dispositifs médicaux de diagnostic in vitro (IVD) destinés à l'autotest. Ce document s'applique spécifiquement aux instruments de diagnostic in vitro utilisés par les patients eux-mêmes, ainsi qu'aux appareils et équipements qui peuvent être associés à ces instruments. Un des points forts de cette norme est qu'elle couvre non seulement les instruments principaux, mais aussi les accessoires qui peuvent être utilisés avec ces dispositifs d'autotest. Cela garantit une approche exhaustive pour l'étiquetage et les informations nécessaires, ce qui est essentiel pour la sécurité et la compréhension de l'utilisateur final. En s'assurant que toutes les informations pertinentes sont fournies, la norme contribue à minimiser les risques d'erreurs lors de l'utilisation des dispositifs IVD, renforçant ainsi la confiance des utilisateurs dans ces technologies. De plus, la norme est particulièrement pertinente dans le contexte actuel où les autotests gagnent en popularité, en particulier dans des domaines tels que les tests de santé à domicile. En définissant clairement les obligations des fabricants, la norme SIST EN ISO 18113-5:2012 joue un rôle clé dans la standardisation de l'information, favorisant l'harmonisation des pratiques à l'échelle internationale. En somme, la SIST EN ISO 18113-5:2012 est un document fondamental pour la régulation et la convivialité des dispositifs médicaux de diagnostic in vitro pour autotest, assurant que les utilisateurs bénéficient des informations complètes et claires nécessaires pour un usage efficace et sécurisé de ces instruments.
SIST EN ISO 18113-5:2012は、自己検査用の体外診断医療機器に関する標準であり、製造者が提供する情報の重要性を強調しています。この標準は、自己検査用の体外診断（IVD）機器に関して、製造者が提供するラベリング情報の要件を詳細に定めています。 この標準のスコープは非常に幅広く、自己検査用IVD機器だけでなく、これらの機器とともに使用される装置や機器、さらには付属品にも適用されます。このため、SIST EN ISO 18113-5:2012は、消費者と製造者の間の透明性を確保し、使用者が製品を正しく理解し、安全に使用できるようにするための重要な基盤を提供しています。 この標準の強みは、製造者が提供する情報が明確で一貫性があり、自己検査用機器の使用におけるリスクを軽減できる点にあります。具体的には、ラベリングが十分であること、使用方法、保管方法、注意事項が明確に示されていることが求められており、これによりユーザーは必要な情報を簡単に見つけることができます。また、製品の安全性を保証するための要件が明文化されており、業界全体での品質向上に寄与しています。 さらに、SIST EN ISO 18113-5:2012は、自己検査用IVD機器における国際基準としての位置付けも兼ね備えており、国際的な市場で競争力を高める助けとなります。製造者がこの標準に準拠することで、グローバルな基準に従った製品開発が促進され、ユーザーの信頼を得ることができます。 このように、SIST EN ISO 18113-5:2012は、自己検査用IVD機器における製造者の情報提供の標準化を推進し、製品の安全性と効果的な使用を支えるための重要な基盤を築いています。
Die SIST EN ISO 18113-5:2012 legt die Anforderungen an die Informationen fest, die von Herstellern von In-vitro-Diagnose (IVD) Instrumenten für Selbsttests bereitgestellt werden müssen. Der Maßstab dieser Norm ist von großer Relevanz, da sie sicherstellt, dass die Verbraucher über die richtigen Informationen verfügen, um IVD-Geräte sicher und effektiv zu nutzen. Ein herausragendes Merkmal der Norm ist die klare Definition von Anforderungen, die nicht nur für die Instrumente selbst, sondern auch für die dazugehörigen Apparate und Ausrüstungen gelten. Dies fördert ein umfassendes Verständnis und eine korrekte Handhabung der Produkte, was insbesondere bei Selbsttests von entscheidender Bedeutung ist. Darüber hinaus ermöglicht die Norm die Anwendung auf Zubehör, was die Flexibilität und den Umfang der Vorgaben erhöht. Dies stellt sicher, dass alle Aspekte der Nutzung von IVD-Instrumenten für Selbsttests abgedeckt sind und trägt somit zur Sicherheit der Benutzer bei. Die Relevanz der SIST EN ISO 18113-5:2012 ist nicht zu unterschätzen, da sie sowohl Hersteller als auch Verbraucher schützt, indem sie die Transparenz und Nachvollziehbarkeit in der Kommunikation von Informationen über IVD-Geräte fördert. Die Anwendung dieser Norm unterstützt zudem die Harmonisierung auf internationaler Ebene und erleichtert den Zugang zu qualitativ hochwertigen Gesundheitsdienstleistungen.
The SIST EN ISO 18113-5:2012 standard provides critical specifications regarding the information that must be supplied by manufacturers of in vitro diagnostic (IVD) instruments specifically designed for self-testing. This standard is an essential component in ensuring that users of self-testing IVD devices receive necessary and accurate information regarding the product. One of the primary strengths of ISO 18113-5:2009 is its comprehensive scope, which not only addresses the information requirements for the instruments themselves but also extends to associated apparatus and equipment. This ensures that all components related to the IVD instruments for self-testing are covered, enhancing user safety and product effectiveness. The standard emphasizes clarity and transparency in labelling, which is paramount for self-testing users who may not have extensive medical training. This focus on user-friendly information is particularly relevant in today's healthcare landscape, where patients are increasingly taking charge of their own health monitoring. Furthermore, the inclusion of guidelines for peripherals and accessories signifies the standard's thorough approach, ensuring that all elements that interact with the IVD instruments provide consistent and reliable information. This holistic view helps mitigate the potential risks associated with misinterpretation or misuse of diagnostic tools. Overall, the relevance of SIST EN ISO 18113-5:2012 within the field of in vitro diagnostics is substantial. It not only ensures compliance with regulatory expectations but also promotes a higher standard of user education, thus fostering trust and reliability in self-testing IVD instruments.
SIST EN ISO 18113-5:2012 표준은 자가 진단을 위한 체외 진단 의료기기(IVD)와 관련된 제조자가 제공하는 정보에 대한 요구사항을 규정하고 있습니다. 이 표준은 특히 자가 진단용 IVD 기기에 필요한 라벨링 정보를 면밀히 다루며, 이러한 기기를 사용할 때 소비자가 이해할 수 있도록 명확하고 정확한 정보를 제공하는 것을 목표로 합니다. 이 표준의 조회 범위는 자가 진단 용도의 IVD 기기뿐만 아니라 이러한 기기와 함께 사용할 수 있는 장비 및 기구에도 적용됩니다. 이는 사용자가 올바른 정보를 바탕으로 자가 진단을 수행할 수 있도록 지원하는 중요한 역할을 합니다. SIST EN ISO 18113-5:2012의 주요 강점은 사용자가 필요한 모든 정보를 쉽게 접근하고 이해할 수 있도록 만들었다는 점입니다. 라벨링 표준은 소비자의 안전과 검사의 정확성을 보장하기 위해 필수적인 요소입니다. 불완전한 정보나 잘못된 라벨링은 사용자가 오용할 가능성을 높여 위험을 초래할 수 있기 때문에, 이 표준은 이를 예방하는 데 중요한 기능을 수행합니다. 또한, 이 표준은 전체 IVD 기기의 품질 관리 시스템과도 관련이 있어, 제조업체가 품질 있는 제품을 제공하기 위한 기준을 마련하는 데 기여합니다. 결과적으로, SIST EN ISO 18113-5:2012는 자가 진단 분야에서의 통합성과 신뢰성을 높이는 데 중요한 역할을 하며, 자가 진단 기기를 사용하는 소비자에게는 필수적으로 필요한 정보 제공의 기준을 제시하고 있습니다. 이 문서는 자가 진단 의료기기와 관련된 가장 최근의 필수 요구사항을 반영하고 있어, 이 분야의 발전과 사용자 안전을 동시에 충족시키는 데 기여하고 있습니다.
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