SIST EN ISO 18113-3:2012
(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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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 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
SIST EN ISO 18113-3:2012
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
EN ISO 18113-3:2011 (E) 2 Contents Page Foreword .3Annex 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 SIST EN ISO 18113-3:2012
EN ISO 18113-3:2011 (E) 3 Foreword This document (EN ISO 18113-3:2011) 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 18113-3:2009. 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 18113-3:2009 has been approved by CEN as EN ISO 18113-3:2011 without any modification. SIST EN ISO 18113-3:2012
EN ISO 18113-3:2011 (E) 4 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 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)
SIST EN ISO 18113-3:2012
EN ISO 18113-3:2011 (E) 5 Clauses of this European Standard Essential Requirements
(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.
SIST EN ISO 18113-3:2012
SIST EN ISO 18113-3:2012
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
SIST EN ISO 18113-3:2012
ISO 18113-3:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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SIST EN ISO 18113-3:2012
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
SIST EN ISO 18113-3:2012
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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