SIST EN 376:2002
(Main)Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents.
NOTE This standard can also be applied to accessories.
Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung
Diese Norm legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen (einschließlich Reagenzprodukte, Kalibriermaterialien, Kontrollmaterialien und Kits), nachstehend IVD-Reagenzien genannt, für die Eigenanwendung fest.
ANMERKUNG Diese Norm kann auch für Zubehör angewendet werden.
Informations fournies par le fabricant de réactifs pour le diagnostic in vitro pour l'utilisation comme auto-test
La présente Norme européenne spécifie les exigences relatives aux informations fournies par le fabricant de réactifs de diagnostic in vitro pour auto-test, y compris les produits réactifs, les calibrateurs, les matériaux de contrôle et les trousses, lesquels sont désignés par le terme réactifs DIV dans la suite du présent document.
NOTE La présente norme peut également etre appliquée aux accessoires.
Informacije proizvajalca o diagnostičnih reagentih in vitro za samopreskušanje
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Information supplied by the manufacturer with in vitro diagnostic reagents for self-testingPRSUHVNXãDQMHInformations fournies par le fabricant de réactifs pour le diagnostic in vitro pour l'utilisation comme auto-testBereitstellung von Informationen durch den Hersteller von Reagenzien für in-vitro-diagnostische Untersuchungen zur EigenanwendungTa slovenski standard je istoveten z:EN 376:2002SIST EN 376:2002en11.100.10In vitro diagnostic test systemsICS:SIST EN 376:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN 376:200201-november-2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 376February 2002ICS 11.100Supersedes EN 376:1992English versionInformation supplied by the manufacturer with in vitro diagnosticreagents for self-testingInformations fournies par le fabricant de réactifs pour lediagnostic in vitro pour l'utilisation comme auto-testBereitstellung von Informationen durch den Hersteller vonReagenzien für in-vitro-diagnostische Untersuchungen zurEigenanwendungThis European Standard was approved by CEN on 20 December 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 376:2002 E
EN 376:2002 (E)2ContentspageForeword31Scope32Normative references33Terms and definitions34Requirements for labels64.1Outer container64.2Immediate container85Requirements for instructions for use9Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or otherprovisions of EU Directives13Bibliography15
EN 376:2002 (E)3ForewordThis European Standard has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medicaldevices", the secretariat of which is held by DIN.The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation.This European Standard shall be given the status of a national standard, either by publication of an identical textor by endorsement, at the latest by August 2002, and conflicting national standards shall be withdrawn at thelatest by August 2002.This European Standard supersedes EN 376:1992.This European Standard has been prepared under a mandate given to CEN by the European Commission andthe European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.1ScopeThis European Standard specifies the requirements for the information supplied by the manufacturer of in vitrodiagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, whichhereafter are called IVD reagents.NOTE
This standard can also be applied to accessories.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest editions of thepublication referred to applies (including amendments).ISO 1000, SI units and recommendations for the use of their multiples and of certain other units.3Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1active ingredientconstituent that participates in the reaction used to measure or detect the analyte [EN 375:2001]
EN 376:2002 (E)43.2batchlotdefined amount of material, either starting material, intermediate or finished product which is uniform in itsproperties and has been produced in one process or series of processes [EN 375:2001]3.3batch codelot numbercode that is a distinctive combination of numbers and/or letters which specifically identifies a batch and permitsits manufacturing history to be traced [EN 375:2001]3.4calibratorsubstance, material or article intended by its manufacturer to be used to establish the measurement relationshipsof an in vitro diagnostic medical device [EN 375:2001]3.5control materialsubstance, material or article intended by its manufacturer to be used to verify the performance characteristics ofan in vitro diagnostic medical device [EN 375:2001]3.6expiry datedate up to which product performance is assured by the manufacturer based on the stability of the IVD reagent[EN 375:2001]3.7immediate containerprimary containerpackaging which protects the contents from contamination and/or other effects of the external environment[EN 375:2001]NOTE
Examples are a sealed vial, ampoule or bottle, a foiled pouch, or a sealed plastics bag containing e. g. teststrips.3.8in vitro diagnostic reagentIVD reagentin vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material or kitNOTE 1
For the definition of an in vitro diagnostic medical device see [4].NOTE 2
In some cases a particular IVD reagent, as defined for use in human medicine, may serve also in veterinarymedicine.[EN 375:2001]
EN 376:2002 (E)53.9instructions for useinformation supplied by the manufacturer with an IVD reagent concerning the safe and proper use of the IVDreagent3.10kitset of components (reagents and/or other materials) packaged together [EN 375:2001]3.11kit componentin vitro diagnostic medical device intended to be part of a kit [EN 375:2001]NOTE
Typical kit components are e. g. reagent carriers, calibrators or control materials.3.12labelprinted, written or graphic information placed on a container [EN 375:2001]3.13lay personindividual who does not have specific medical education3.14outer containersales packagingmaterial used in the packaging of the immediate container(s) of (an) IVD reagent(s) consisting of a single entityor an assembly of different or identical components [EN 375:2001]3.15reagent productreagent carrierproduct in which the reagents are fixed to or included in a carrier [EN 375:2001]EXAMPLES
Test strips, slides, test plates, test sticks.3.16self-testinguse in the home or similar environments by a lay person who will relate the result of the test to him- or herself3.17shelf lifeperiod until expiry date [EN 375:2001]3.18specimenbiological material which is obtained in order to detect or to measure one or more quantities [EN 375:2001]
EN 376:2002 (E)63.19stabilityability of an IVD reagent, when kept under specified conditions, to retain throughout the shelf-life its propertiesand/or performance within limits specified by the manufacturer [EN 375:2001]4Requirements for labels4.1Outer container4.1.1
GeneralThe label for an outer container shall give the information specified in 4.1.2 to 4.1.10.A statement that the instructions for use are to be read carefully shall be made on the outer container or, if spacedoes not permit, in the instructions for use.The language(s) used shall be (an) official Community language(s), legally acceptable in the country in whichthe IVD reagent is distributed; additional languages are optional, bearing in mind the needs of the anticipatedusers. Information which is a proper name, address, or symbol does not require to be expressed in multiplelanguages.4.1.2
ManufacturerThe name and address of the manufacturer shall be given.NOTE
The manufacturer is the entity which has taken legal responsibility for the IVD reagent.The name and address of the authorized representative shall also be given when this is a legal requirement.4.1.3
Product nameThe product name shall be given.When the name does not uniquely identify the product, an additional means of identification shall be given.4.1.4
Microbiological stateIf necessary for proper performance of the reagent, the microbiological state or state of cleanliness,e. g. "microbiologically controlled" or "sterile", shall be given.4.1.5
Batch codeA batch code shall be given.If a kit contains different components bearing different batch codes, the batch code given on the outer containershall enable the product history to be traced from the manufacturer's production files.NOTE
The graphical symbol as given in EN 980 should be used.
EN 376:2002 (E)74.1.6
Expiry dateAn expiry date based upon the stated storage instructions shall be given. This shall be expressed as the year, themonth, and, where relevant, the day, in that order. In the case of year and month this means that the expiry dateis the last day of the month indicated. The label of the outer container shall give the expiry date of the componenthaving the earliest expiry date or an earlier date, if appropriate.NOTE 1
The graphical symbol as given in EN 980 should be used.NOTE 2
The format for the expiry date should be either "CCYY-MM-DD" or "CCYY-MM".4.1.7
ContentsThe number of measurements or tests that can be performed shall be stated.In the case of a kit the components shall be identified in the same way as on the label of the immediatecontainers as specified in 4.2.3.4.1.8
Intended purposeA brief indication, e. g. "pregnancy test", plus a statement in lay terms clearly signifying in vitro use, e. g. "not tobe swallowed", shall be given. The fact that the IVD reagent is intended for self-testing shall be clearly stated.NOTE
A graphical symbol for in vitro diagnostic medical device should be used.1)4.1.9
Storage and handling informationThe storage conditions necessary to assure the stability of the product in the unopened state shall be indicated.Recommended storage temperature intervals shall be given.EXAMPLES:2
°C to 8 °Cor 2.8 °Corgraphical symbol according to ISO 7000-0632-18 °C or below or
-18 °Cor graphical symbol according to ISO 7000-0533Other conditions that affect stability (e. g. light or humidity) shall be mentioned.Any other particular measures to be taken in the handling of the product shall be given (e. g. "treat as fragile").4.1.10
Warnings and precautionsIf an IVD reagent is considered dangerous (e. g. chemical or biological risk), the outer container shall be labelledwith the appropriate danger symbol(s). In the case of chemical hazards, if the IVD reagent is not accompanied byinstructions for use giving appropriate risk and safety phrases, these phrases shall be given on the label of theouter container.NOTE
For chemical hazards labelling see [3].
1) Graphical symbol as given in ISO 15223/DAM 1:1999 and as proposed for a future revision of EN 980.
EN 376:2002 (E)84.2Immediate container4.2.1
GeneralThe label for an immediate container shall give the information specified in 4.2.2 to 4.2.10 in legible charactersand/or symbols. If the available space is too small for this purpose, the information may be reduced to 4.2.2,4.2.3, 4.2.5, 4.2.6 and 4.2.10.The language(s) used shall be (an) official Community language(s), legally acceptable in the country in whichthe IVD reagent is distributed; ad
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