EN ISO 18113-1:2009
(Main)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009)
Dieser Teil von ISO 18113 definiert Konzepte, stellt allgemeine Prinzipien auf und legt wesentliche Anforderungen an die durch den Hersteller von In vitro Diagnostika bereitzustellenden Informationen fest.
Dieser Teil von ISO 18113 enthält keine Festlegungen zu sprachlichen Anforderungen, da es sich hierbei um den Bereich nationaler Gesetze und Vorschriften handelt.
Dieser Teil von ISO 18113 gilt nicht für
a) In vitro Diagnostika zur Leistungsbewertung (z. B. nur für Forschungszwecke),
b) Kennzeichnung von Geräten,
c) Datenblätter zur Materialsicherheit.
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)
L'ISO 18113-1:2009 définit les concepts, établit les principes généraux et spécifie les exigences essentielles relatives aux informations fournies par le fabricant de dispositifs médicaux de DIV.
Diagnostični preskusni sistemi in vitro - Informacije proizvajalca (označevanje) - 1. del: Izrazi, definicije in splošne zahteve (ISO 18113-1:2009)
Ta del ISO 18113 opredeljuje koncepte, vzpostavlja splošna načela in določa bistvene zahteve za informacije proizvajalca diagnostičnih preskusnih sistemov in vitro. Ta del ISO 18113 ne obravnava jezikovnih zahtev, saj to spada na področje nacionalnih zakonov in predpisov.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009)Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN ISO 18113-1:2009SIST EN ISO 18113-1:2010en01-marec-2010SIST EN ISO 18113-1:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 18113-1
December 2009 ICS 11.100.10 English Version
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1: Termes, définitions et exigences générales (ISO 18113-1:2009)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009) This European Standard was approved by CEN on 18 November 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18113-1:2009: ESIST EN ISO 18113-1:2010
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 18113-1:2010
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 International 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 confers, within the limits of the scope of this International Standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and European Directive 98/79/EC
Clause(s)/subclause(s) of this International Standard Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes This Standard B.7, B.8.1, B.8.2, B.8.3, B.8.4, B.8.7
4.1 B.8.1
4.3 B.8.2
4.5 B.8.4 (c)
4.6 B.8.1, B.8.7 NOTE 1 Compliance with MEDDEV 2.14/3, IVD Guidances: Supply of Instructions For Use (IFU) and other information for In vitro Diagnostic (IVD) Medical Devices — A Guide for Manufacturers and Notified Bodies, is required to ensure presumption of conformity in the cases where IFU are provided separately from the device.
NOTE 2 Essential requirement B.8.7 of Directive 98/79/EC should be consulted for a comprehensive list of the information required. 4.6.4 B.8.7 (u)
4.8 B.8.3, B.8.4 (j), B.8.7 (s) NOTE Essential requirement B.8.3 of Directive 98/79/EC should be consulted for a comprehensive list of the information required 4.9 B.8.4 (b)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. NOTE 1 In the European Union, Directive 98/79/EC requires the manufacturer to designate an “EC authorized representative”, established in the European Community if the manufacturer is not located in the European Community. In those instances, notes within this standard which refer to Authorized representatives should be considered in Europe as normative, not informative.
NOTE 2 MEDDEV 2.14/3 rev 1 (2007) is available from the European Commission's website at the following address: http://ec.europa.eu/enterprise/medical_devices/meddev/2_14_3_rev1_ifu_final.pdf. SIST EN ISO 18113-1:2010
Reference numberISO 18113-1:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO18113-1First edition2009-12-15In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) — Partie 1: Termes, définitions et exigences générales
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ii © ISO 2009 – All rights reserved
ISO 18113-1:2009(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 General requirements for information supplied by the manufacturer.17 4.1 General.17 4.2 Language.18 4.3 Symbols and identification colours.18 4.4 Values and nomenclature.18 4.5 Microbiological state.18 4.6 Instructions for use.18 4.7 Changes to the IVD medical device.19 4.8 Disclosure of residual risks.19 4.9 Identification of components.20 4.10 Assistance.20 Annex A (informative)
Performance characteristics of IVD medical devices.21 Bibliography.45
ISO 18113-1:2009(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 18113-1 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 devices — Information supplied by the manufacturer (labelling): ⎯ Part 1: Terms, definitions and general requirements ⎯ Part 2: In vitro diagnostic reagents for professional use ⎯ Part 3: In vitro diagnostic instruments for professional use ⎯ Part 4: In vitro diagnostic reagents for self-testing ⎯ Part 5: In vitro diagnostic instruments for self-testing SIST EN ISO 18113-1:2010
ISO 18113-1:2009(E) © ISO 2009 – All rights reserved v Introduction Manufacturers of in vitro diagnostic (IVD) medical devices supply users with information to enable the safe use and expected performance of their devices. Traditionally, this information has been provided in the form of labels, package inserts and user manuals, where the type and level of detail would depend on the intended uses and country-specific regulations. The Global Harmonization Task Force (GHTF) encourages convergence of the evolution of regulatory systems for medical devices at the global level. The goal is to facilitate trade while preserving the right of participating members to address the protection of public health by regulatory means. Consistent worldwide labelling requirements offer significant benefits to manufacturers, users, patients and regulatory a
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