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.
General Information
Relations
Related Packages
Frequently Asked Questions
SIST EN ISO 18113-3:2012 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 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.
SIST EN ISO 18113-3:2012 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 18113-3:2012 has the following relationships with other standards: It is inter standard links to SIST EN ISO 18113-3:2010, SIST EN ISO 18113-3:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 18113-3:2012 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.
You can purchase SIST EN ISO 18113-3:2012 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.
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
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
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.
©
ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
+ 41 22 749 01 11 Fax
+ 41 22 749 09 47 E-mail
copyright@iso.org Web
www.iso.org Published in Switzerland ii © ISO 2009 – All rights reserved
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
...
SIST EN ISO 18113-3:2012는 전문 사용을 위한 체외 진단(IVD) 기기 제조업체가 제공해야 하는 정보에 대한 요구사항을 규정합니다. 이 표준은 IVD 기기뿐만 아니라 이를 장착하여 사용할 수 있는 기기 및 장비에 대해서도 적용됩니다. 또한, 적절한 경우에는 관련 액세서리에도 적용할 수 있습니다. 이러한 포괄적인 범위는 다양한 의료 환경에서의 유용성을 극대화합니다. 이 표준의 강점 중 하나는 의료 기기의 라벨링과 관련된 정보 제공의 일관성을 보장한다는 점입니다. 체외 진단 기기는 종종 중요한 임상 결정을 내리는 데 사용되므로, 정확하고 명확한 정보의 제공은 환자 안전과 진단 정확도를 높이는 데 기여합니다. 제조업체가 제공해야 하는 정보에는 사용 지침, 준비 방법, 안전 정보 등이 포함되어 있어, 사용자들이 기기를 올바르게 사용할 수 있도록 돕습니다. SIST EN ISO 18113-3:2012는 또한 글로벌 규제 준수 측면에서도 중요한 역할을 합니다. 전문 의료 기기관련 국제 표준을 준수함으로써, 제조업체는 다양한 국가에서 제품을 효율적으로 유통할 수 있는 기반을 마련합니다. 이는 특히 국제 시장에서의 경쟁력을 높이는 데 기여합니다. 결국, SIST EN ISO 18113-3:2012는 체외 진단 의료 기기의 제조업체가 제공해야 할 정보의 명확성을 요구함으로써, 사용자와 환자의 안전을 증대시키고, 글로벌 시장에서의 법적 요건 충족을 지원하는 중요한 표준입니다.
SIST EN ISO 18113-3:2012は、専門的な使用のための体外診断（IVD）機器に関する標準であり、製造者が提供する情報の要件を規定しています。この標準の範囲は、IVD機器のラベリングに関する要求事項を包括しており、機器とその付属品、さらにはIVD機器と共に使用される装置や設備にまで及びます。 この標準の強みは、専門的な使用向けの体外診断機器に対して、製造者が提供すべき情報の一貫性と明確さを保証する点です。ISO 18113-3:2009では、使用される機器が適切に選定され、使用者が正確な情報を受け取ることができるように設計されており、医療現場での信頼性や安全性を高める役割を果たしています。 さらに、この標準は体外診断機器に関連するアクセサリーについても適用可能であり、必要に応じてこれらの情報を含めることが求められます。これによって、すべての関連情報が一元管理され、使用者が必要とする全てのデータに簡単にアクセスできる環境が整います。 SIST EN ISO 18113-3:2012は、医療機器のラベリングにおける国際的な基準を反映したものであり、品質管理や規制遵守の観点からも非常に関連性の高い標準です。特に、医療従事者にとっては、正確な情報が安全な診断を行うための不可欠な要素であるため、この標準の遵守は極めて重要です。
The SIST EN ISO 18113-3:2012 is a critical standard that outlines the requirements for information provided by manufacturers of in vitro diagnostic (IVD) instruments intended for professional use. This standard plays an essential role in ensuring that all stakeholders, including healthcare professionals and patients, receive clear and comprehensive information regarding the use, maintenance, and safety of these diagnostic instruments. One of the significant strengths of ISO 18113-3:2009 is its comprehensive nature. It sets forth detailed guidelines that cover not only IVD instruments but also related apparatus and equipment, thereby providing a holistic approach to labelling and information dissemination. This ensures that all components used in conjunction with IVD instruments are adequately described, which is vital for maintaining quality and safety in diagnostics. The relevance of this standard cannot be overstated. As the healthcare landscape evolves and the complexity of in vitro diagnostic technologies increases, having a standardized approach to manufacturer information becomes crucial for ensuring compliance and facilitating effective communication. By adhering to the specifications set forth in SIST EN ISO 18113-3:2012, manufacturers can enhance the usability of their products, thereby improving patient care outcomes. Additionally, the applicability of this standard to accessories, where appropriate, emphasizes its flexibility and adaptability in addressing various components involved in the use of IVD instruments. This comprehensive coverage ensures that all relevant products are included in the standardization process, further reinforcing the integrity and reliability of in vitro diagnostics. In summary, the SIST EN ISO 18113-3:2012 sets a high benchmark for manufacturers of in vitro diagnostic instruments by providing clear, detailed requirements for labelling and information provision. Its strengths lie in its comprehensive framework, relevance to modern healthcare practices, and flexibility in application, making it an invaluable standard for anyone involved in the field of in vitro diagnostics.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...