EN ISO 18113-3:2011
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009)
Der vorliegende Teil von ISO 18113 legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Geräten für in vitro diagnostische Untersuchungen zum Gebrauch durch Fachpersonal fest.
Dieser Teil von ISO 18113 gilt auch für Ausrüstungen und Materialien, die für den Gebrauch von Geräten für in vitro diagnostische Untersuchungen zum Gebrauch durch Fachpersonal 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;
c) IVD Instrumente zur Eigenanwendung.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO 18113-3:2009)
L'ISO 18113-3:2009 spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de DIV pour usage professionnel.
L'ISO 18113-3:2009 s'applique aussi aux appareillages et équipements destinés à être utilisés avec les instruments de DIV pour usage professionnel.
L'ISO 18113-3:2009 peut aussi s'appliquer aux accessoires, le cas échéant.
Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 3. del: Diagnostični instrumenti in vitro za poklicno uporabo (ISO 18113-3:2009)
Ta del ISO 18113 določa zahteve za informacije proizvajalca diagnostičnih instrumentov in vitro za poklicno uporabo. Ta del ISO 18113 velja tudi za aparate in opremo, ki se uporabljajo z diagnostičnimi instrumenti in vitro za poklicno uporabo. 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 za uporabo in nadzor reagentov; c) diagnostične instrumente in vitro za samopreskušanje.
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EN ISO 18113-3:2011 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 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)". This standard covers: ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.
EN ISO 18113-3:2011 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 18113-3:2011 has the following relationships with other standards: It is inter standard links to EN ISO 18113-3:2009, EN ISO 18113-3:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 18113-3:2011 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 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.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009)Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO 18113-3:2009)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN ISO 18113-3:2011SIST EN ISO 18113-3:2012en01-januar-2012SIST EN ISO 18113-3:2012SLOVENSKI
STANDARDSIST EN ISO 18113-3:20101DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18113-3
October 2011 ICS 11.100.10 Supersedes EN ISO 18113-3:2009English Version
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO 18113-3:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2009) 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 worldwide for CEN national Members. Ref. No. EN ISO 18113-3:2011: ESIST EN ISO 18113-3:2012
Relationship between this European Standard and the Essential Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” .4 SIST EN ISO 18113-3:2012
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 Standard Essential Requirements
(ERs) of Directive 98/79/EC
Qualifying
comments/Notes 5, 6, 7
B.8.1 Presumption of conformity with ER B.8.1 also requires compliance with clauses 4.1, 4.2.1 and 4.6 of EN ISO 18113-1. 7.1 B.8.4(a)
NOTE 1 5.2.1 B.8.4(b)
5.2.2 B.8.4(d) Full compliance with ER B.8.4(d) requires the use of EN 980, 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
7.1, 7.2.1, 7.3, 7.4, 7.5, 7.12 B.8.7(a) Presumption of conformity with ER B.8.7(a) requires compliance also with clause 4.5 of
EN ISO 18113-1.
NOTE 1
NOTE 2 7.9. B.8.7(d)
7.2.2, 7.11, 7.12 B.8.7(e)
7.11, 7.12 B.8.7(f)
7.12, 7.15, 7.17 B.8.7(g)
7.7, 7.8, 7.9, 7.10, 7.11, 7.12 B.8.7(h)
7.14 B.8.7(i)
7.20 B.8.7(j)
7.13 B.8.7(k)
7.6, 7.11, 7.12 B.8.7(m)
7.6, 7.11, 7.12, 7.13, 7.18, 7.19 B.8.7(n)
7.11 B.8.7(o)
(ERs) of Directive 98/79/EC
Qualifying
comments/Notes 7.19 B.8.7(p)
7.19 B.8.7(q) This clause covers only partially ER B.8.7(q), namely only the information about cleaning, decontamination or disinfection. Any other information related to reuse and restrictions on the number of reuse does not apply to this kind of IVD medical device. 7.5, 7.6.3, 7.11 B.8.7(r)
NOTE 2 7.5, 7.18 B.8.7(s)
NOTE 2 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.
Reference numberISO 18113-3:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO18113-3First edition2009-12-15In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — Partie 3: Instruments de diagnostic in vitro à usage professionnel
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ISO 18113-3:2009(E) © ISO 2009 – All rights reserved iii 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.2 7 Content of the instructions for use.3 7.1 Manufacturer.3 7.2 Identification of the IVD instrument.3 7.3 Intended use.3 7.4 Storage and handling.4 7.5 Warnings and precautions.4 7.6 Instrument installation.4 7.7 Theory of operation.5 7.8 Functions.5 7.9 Performance of the IVD instrument.5 7.10 Limitations of use.6 7.11 Preparation prior to operation.6 7.12 Operating procedure.6 7.13 Control procedure.6 7.14 Calculation of examination results.6 7.15 Special functions.7 7.16 Emergency primary samples.7 7.17 Shut-down procedure.7 7.18 Disposal information.7 7.19 Maintenance.7 7.20 Troubleshooting.8 Bibliography.9
ISO 18113-3:2009(E) iv © ISO 2009 – All rights reserved 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 18113-3 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. ISO 18113 consists of the following parts, under the general title In vitro diagnostic medical d
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The EN ISO 18113-3:2011 standard provides crucial requirements for information supplied by manufacturers of in vitro diagnostic (IVD) instruments intended for professional use. Its defined scope encompasses not only the IVD instruments themselves but also the apparatus and equipment that may be employed alongside these instruments, thereby ensuring a comprehensive approach to labelling and documentation. One of the strengths of ISO 18113-3:2009 is its focus on clear and consistent information dissemination, which is vital for users to understand the functionalities, applications, and limitations of the IVD instruments. This clarity supports healthcare professionals in making informed decisions, ultimately enhancing patient safety and diagnostic accuracy. Furthermore, the standard addresses the requirement for labelling of accessories related to IVD instruments, reinforcing its applicability beyond just the primary devices. This inclusivity ensures that all components associated with IVD testing are adequately represented, facilitating greater awareness and adherence to safety and efficacy standards. The relevance of EN ISO 18113-3:2011 in today’s healthcare landscape cannot be overstated. As the complexity of in vitro diagnostic devices increases, the need for standardized information grows correspondingly. By adhering to this standard, manufacturers contribute to a unified understanding of their products, promoting consistency in the market and enhancing compliance with regulatory frameworks. Overall, the EN ISO 18113-3:2011 standard stands out as a foundational document in the realm of IVD instruments for professional use, tackling key requirements for labelling that significantly impact the effectiveness and safety of in vitro diagnostics in clinical practice.
EN ISO 18113-3:2011 표준은 전문 사용을 위한 인 비트로 진단 의료 기기에 대한 제조자의 정보 제공(라벨링)에 관한 요구사항을 명시하고 있습니다. 이 표준은 인 비트로 진단(IVD) 기기뿐만 아니라, 이러한 기기와 함께 사용되는 장치 및 장비에도 적용됩니다. 따라서 EN ISO 18113-3:2011은 의료 기기의 라벨링과 관련된 모든 측면을 포괄하는 중요한 문서입니다. 이 표준의 강점 중 하나는 정보의 일관성을 보장하여 사용자가 제품을 올바르게 이해하고 사용할 수 있도록 돕는 것입니다. 제조자에게 제공해야 할 정보의 유형과 형태를 명확히 규정함으로써, 정보의 투명성을 높이고 사용자 안전성을 증대시킵니다. 이러한 요구사항은 특히 다양한 의료 환경에서 전문적인 사용자들이 필요한 정보를 신속하고 정확하게 접근할 수 있도록 하는 데 매우 중요합니다. EN ISO 18113-3:2011은 또한 장비와 액세서리와 관련된 정보 요구사항을 포함하고 있어, 다양한 상황에서의 유연성을 제공합니다. 이를 통해 의료 기술자나 전문가가 특정 기기를 사용할 때, 필요한 모든 정보를 손쉽게 확인할 수 있어 임상적 의사결정을 지원합니다. 결론적으로, EN ISO 18113-3:2011 표준은 인 비트로 진단 의료 기기에 관련된 제조자의 정보 제공에 대한 필수적인 지침을 제공하며, 전문 사용자가 신뢰할 수 있는 정보를 바탕으로 장비를 안전하게 사용할 수 있도록 돕고 있습니다. 이 표준은 현재의 의료 환경에서 매우 중요한 역할을 하고 있으며, 지속적으로 그 중요성이 확대될 것으로 기대됩니다.
EN ISO 18113-3:2011は、医療機器の一部としての体外診断用（IVD）機器のラベリングに関する重要な基準を提供します。この標準は、プロフェッショナル用途のために設計されたIVD機器に関する製造者が提供する情報の要件を詳細に規定しています。特に、情報の透明性と一貫性を確保することで、医療プロフェッショナルが機器を正しく使用し、患者の安全を守るために重要な役割を果たします。 この標準の強みは、その包括的な範囲にあります。EN ISO 18113-3は、IVD機器だけでなく、これらの機器と併せて使用される器具や設備にも適用されるため、広範な適用性を持っています。これにより、業界全体での一貫したラベリングが可能となり、ユーザーの理解度を向上させ、誤使用のリスクを低減します。 さらに、必要に応じて付属品にも適用可能な点が特に優れており、製造者は付属品全体に渡り、一貫した情報を提供することが求められます。これにより、プロフェッショナルがIVD機器を使用する際の総合的な環境を整え、医療行為の質を向上させます。 EN ISO 18113-3:2011の関連性は、医療分野における規制やガイドラインがますます厳格化される中で、特に重要です。製造者はこの標準を遵守することで、製品の安全性と効果を保証し、市場での信頼性を高めることができるため、医療機器業界全体において重要な基準としての地位を確立しています。
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