1、January 2013 Translation by DIN-Sprachendienst.English price group 21No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 11.100.10!$W5“1935218www.din.deDDIN EN ISO 18113-1Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements (ISO 18113-1:2009);English version EN ISO 18113-1:2011,English translation of DIN EN ISO 18113-1:2013-01Bereitstellung von Informationen durch
3、den Hersteller Teil 1: Begriffe und allgemeine Anforderungen (ISO 18113-1:2009);Englische Fassung EN ISO 18113-1:2011,Englische bersetzung von DIN EN ISO 18113-1:2013-01Informations fournies par le fabricant (tiquetage) Partie 1: Termes, dfinitions et exigences gnrales (ISO 18113-1:2009);Version ang
4、laise EN ISO 18113-1:2011,Traduction anglaise de DIN EN ISO 18113-1:2013-01SupersedesDIN EN ISO 18113-1:2010-05See start of applicationwww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.In vitro diagnostic medical devices In-vitro-Dia
5、gnostika Dispositifs mdicaux de diagnostic in vitro 5912.12 DIN EN ISO 18113-1:2013-01 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2013-01-01. DIN EN ISO 18113-1:2010-05 may be used in parallel until 2014-10-31. National oreword This sta
6、ndard (EN ISO 18113-1:2011) 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” (Secretariat: DIN, Germany). The responsible German body invol
7、ved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-03-03 AA Qualittsmanagement in medizinischen Laboratorien. DIN EN ISO 18113 consists of the following parts, under the general title In vitro diagnostic medical devices Information supplied
8、 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 f
9、or self-testing The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5725-1 DIN ISO 5725-1 ISO 5725-3 DIN ISO 5725-3 ISO 8601 DIN ISO 8601 ISO 13485 DIN EN ISO 13485 ISO 14971 DIN EN ISO 14971 ISO 15197 DIN EN ISO 15197 ISO 17511 DIN EN ISO
10、17511 ISO 18153 DIN EN ISO 18153 ISO/IEC Guide 51 DIN 820-120 ISO/IEC 17025 DIN EN ISO/IEC 17025 Amendments This standard differs from DIN EN ISO 18113-1:2010-05 as follows: a) Annex ZA has been revised and rendered more precise. fDIN EN ISO 18113-1:2013-01 3 Previous editions DIN EN ISO 18113-1: 20
11、10-05 National Annex NA (informative) Bibliography DIN ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions DIN ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results Part 3: Intermediate measures of the
12、 precision of a standard measurement method DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14971, Medical devices Application of
13、 risk management to medical devices DIN EN ISO 15197, In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus DIN EN ISO 17511, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological t
14、raceability of values assigned to calibrators and control materials DIN EN ISO 18153, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials DIN 820-1
15、20, Standardization Part 120: Guidelines for the inclusion of safety aspects in standards DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO 18113-1:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N
16、ORM EN ISO 18113-1 October 2011 ICS 11.100.10 Supersedes EN ISO 18113-1:2009English Version In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) Dispositifs mdicaux de diagnostic in vitro -
17、 Informations fournies par le fabricant (tiquetage) - Partie 1: Termes, dfinitions et exigences gnrales (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 approv
18、ed 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 nationa
19、l 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
20、 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,
21、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels
22、2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18113-1:2011: EContents Page Foreword .3 Introduction.4 1 Scope6 2 Normative references6 3 Terms and definitions .7 4 General requirements for information supplied by the man
23、ufacturer.22 4.1 General .22 4.2 Language23 4.3 Symbols and identification colours.23 4.4 Values and nomenclature.23 4.5 Microbiological state.23 4.6 Instructions for use.23 4.7 Changes to the IVD medical device.24 4.8 Disclosure of residual risks .24 4.9 Identification of components .25 4.10 Assist
24、ance25 Annex A (informative) Performance characteristics of IVD medical devices.26 Bibliography50 2 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” .55DIN EN ISO 18113-1:2013-01 EN
25、 ISO 18113-1:2011 (E) Foreword 3 This document (EN ISO 18113-1:2011) 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 whi
26、ch 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 possib
27、ility 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 18113-1:2009. This new edition contains a revised Annex ZA. This document has been pre
28、pared 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
29、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
30、, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 18113-1:2009 has been approved by CEN as EN ISO 18113-1:2011 without any modification. “ DIN EN ISO 18113-1:2013-01 EN ISO 18113-1:2011 (E) I
31、ntroduction 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 o
32、f 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 m
33、embers to address the protection of public health by regulatory means. Consistent worldwide labelling requirements offer significant benefits to manufacturers, users, patients and regulatory authorities. Eliminating differences among regulatory jurisdictions could allow patients earlier access to ne
34、w technologies and treatments by decreasing the time necessary to gain regulatory compliance. See Reference 36. This part of ISO 18113 provides a basis for harmonization of labelling requirements for IVD medical devices. The GHTF has established guiding principles that apply to the labelling of medi
35、cal devices. See Reference 36. These principles have been incorporated into the ISO 18113 series. Of particular note, GHTF states that country-specific requirements for the content, wording and format of labels and instructions for use should be kept to a minimum, and eliminated over time as the opp
36、ortunities arise. This part of ISO 18113 contains a comprehensive list of terms and definitions necessary to develop the labelling for IVD medical devices. Internationally agreed-upon definitions of important concepts promote greater consistency in IVD medical device labelling. While the goal is to
37、standardize the terminology used in IVD medical device labelling to the extent possible, it is also recognised that current national and regional usage by medical laboratories, healthcare providers, patients and regulatory authorities must be respected. An obstacle to the timely and affordable avail
38、ability of IVD medical devices in some countries is the requirement for information to appear in multiple languages. Wherever practical, GHTF encourages the use of standardized, internationally recognised symbols as long as safe use of the device is not compromised by diminished understanding on the
39、 part of the user. This part of ISO 18113 provides support for the use of symbols consistent with the GHTF objectives. GHTF also encourages manufacturers to employ the most appropriate methods of delivering information. Until recently, most information had been supplied as printed materials accompan
40、ying the IVD medical device. Modern technologies enable instructions for use and technical information to be provided using a more efficient means of delivery. Information can be digitally encoded on magnetic or optical media, displayed on a screen, incorporated in the device, or even transmitted ov
41、er the internet at the time of use. These advances offer users the possibility of more timely availability of critical information, such as performance changes, and offer manufacturers more effective means of disseminating the information. The ISO 18113 series specifies requirements for information
42、supplied by the manufacturer of IVD medical devices. It consists of five parts, allowing it to address the specific needs of professional users and self-testing users in the most appropriate manner. Furthermore, since manufacturers provide different types of information for IVD reagents and instrume
43、nts, their requirements are addressed in separate parts of the ISO 18113 series. This part of ISO 18113 is not intended to be used alone. It contains terms, definitions and general principles that apply to all parts of ISO 18113. In addition, guidelines for the terms and definitions that describe th
44、e performance characteristics of IVD medical devices are given in Annex A. This information is not repeated in the subsequent parts, so this document is indispensable to the application of ISO 18113-2, ISO 18113-3, ISO 18113-4 and ISO 18113-5. ISO 18113-2 specifies the requirements for labels and in
45、structions for use supplied with IVD reagents, calibrators and control materials for professional use. ISO 18113-3 specifies the requirements for labels and instructions for use supplied with IVD instruments for professional use. ISO 18113-4 specifies the 4 DIN EN ISO 18113-1:2013-01 EN ISO 18113-1:
46、2011 (E) requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for self-testing. ISO 18113-5 specifies the requirements for labels and instructions for use supplied with IVD instruments for self-testing. Parts 1, 2 and 3 of ISO 18113 are the I
47、nternational Standards necessary for IVD medical devices intended for medical laboratories and other professional uses; Parts 1, 4 and 5 of ISO 18113 are the International Standards necessary for IVD medical devices intended for self-testing. However, recognising that manufacturers often provide sys
48、tems comprising an instrument with dedicated reagents, these International Standards allow the flexibility to provide the necessary information in the most appropriate format for the intended users, for example, a single operators manual for an integrated IVD medical device system. 5 DIN EN ISO 18113-1:2013-01 EN ISO 18113-1:2011 (E) 1 Scope This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD me
