DIN EN ISO 19001-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001 2013) Germ.pdf

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1、July 2013Translation by DIN-Sprachendienst.English price group 12No 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).ICS 11

2、.100.10!%English version EN ISO 19001:2013,English translation of DIN EN ISO 19001:2013-07In-vitro-Diagnostika Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischenReagenzien fr biologische Frbungen (ISO 19001:2013);Englische Fassung EN ISO 19001:2013,Englische bersetzung

3、 von DIN EN ISO 19001:2013-07Dispositifs mdicaux de diagnostic in vitro Informations fournies par le fabricant avec les ractifs de coloration de diagnostic in vitroutiliss en biologie (ISO 19001:2013);Version anglaise EN ISO 19001:2013,Traduction anglaise de DIN EN ISO 19001:2013-07SupersedesDIN EN

4、12376:1999-04See start of applicationwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 20 pages06.13 DIN EN ISO 19001:2013-07 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2013-

5、07-01. DIN EN ISO 19001:2013-07 may be used in parallel until 2016-02-29. National foreword This document (EN ISO 19001:2013) 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 “I

6、n vitro diagnostic medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-05-11 AA Frbungen in Histologie und Zytologie. The DIN Standards corresponding to the Inter

7、national Standards referred to in this document are as follows: ISO 18113-1 DIN EN ISO 18113-1 ISO 18113-2 DIN EN ISO 18113-2 Amendments This standard differs from DIN EN 12376:1999-04 as follows: a) normative references have been updated; b) the definitions have been revised; c) the headings of Sub

8、clauses 4.1.3 and 4.1.4 have been modified; d) the standard has been editorially revised; e) in Annex A, the description of the staining procedures and dye properties has been revised. Previous editions DIN EN 12376: 1999-04 National Annex NA (informative) Bibliography DIN EN ISO 18113-1, In vitro d

9、iagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements DIN EN ISO 18113-2, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use EU

10、ROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19001 March 2013 ICS 11.100.10; 11.040.55 Supersedes EN 12376:1999English Version In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) Dispositi

11、fs mdicaux de diagnostic in vitro - Informations fournies par le fabricant avec les ractifs de coloration de diagnostic in vitro utiliss en biologie (ISO 19001:2013) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien fr biologische Frb

12、ungen (ISO 19001:2013) This European Standard was approved by CEN on 14 March 2013. 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 an

13、d 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

14、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, Former Yugosla

15、v Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE

16、 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19001:2013: EContents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Norm

17、ative references. 5 3 Terms and definitions 5 4 Requirements for information supplied by the manufacturer . 7 4.1 General requirements 7 4.2 Additional requirements for specific kinds of reagent . 8 Annex A (informative) Examples of information supplied by the manufacturer with reagents commonly use

18、d in biological staining procedures 11 Bibliography 17 2DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) Foreword This document (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems in collaboration with Technical Commi

19、ttee 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 September 2013, and conflicting national standards sh

20、all be withdrawn at the latest by March 2016. 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 12376:1999.

21、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, Former Yugoslav Republic of Macedonia, France, Ger

22、many, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19001:2013 has been approved by CEN as EN ISO 19001:

23、2013 without any modification. “”3DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) IntroductionThis International Standard relates to ISO 18113-1 and ISO 18113-2, which can be used in conjunction with it.The use of reagents required for staining in biology as well as the specific examples of informati

24、on supplied by the manufacturer for two staining procedures as provided in Annex A are based on a European consensus; they constitute the scientific justification for the requirements listed in Clause 4. This information is intended to assist manufacturers, suppliers and vendors of dyes, stains, chr

25、omogenic reagents and other reagents used for staining in biology in complying with the required specific product data.4DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) 1 ScopeThis International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining

26、 in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requ

27、irements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.2 Normative referencesThe following referenced documents are indispensable for the application of t

28、his document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 80000-1, Quantities and units Part 1: GeneralISO 80000-9, Quantities and units Part 9: Physical chemistry and molecular phy

29、sicsISO 18113-1, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirementsISO 18113-2, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for

30、professional use3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1antibodyspecific immunoglobulin formed by B-lymphocytes in response to exposure to an immunogenic substance and able to bind to thisNote 1 to entry: The molecule of an immunogenic s

31、ubstance contains one or more parts with a characteristic chemical configuration, an epitope.3.2blocking reagentreagent that is used to reduce the inherent background of a sample before staining3.3chromogenic reagentreagent that reacts with certain chemical groups present or induced in cells and tis

32、sues with the formation of a coloured compound in situEXAMPLE Diazonium salt, Schiffs reagent.5DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) 3.4dyecoloured organic compound that, when dissolved in a suitable solvent, can impart colour to a material3.5fluorochromereagent that emits visible light whe

33、n irradiated with excitation light of a shorter wavelengthNote 1 to entry: Any of various fluorescent substances used in biological staining to produce fluorescence in a sample.3.6in vitro diagnostic reagentIVD reagentchemical, biological or immunological component, solution or preparation intended

34、by the manufacturer to be used as an IVD medical deviceISO 18113-13.7information supplied by the manufacturerlabellingwritten, printed or graphic matter affixed to an IVD medical device or any of its containers or wrappers or provided for use with an IVD medical device,related to identification, tec

35、hnical description, and use of the IVD medical device, but excluding shipping documentsEXAMPLE Labels, instructions for use.Note 1 to entry: Catalogues are not considered labelling of IVD medical devices.ISO 18113-13.8labelprinted, written or graphic information placed on a medical device or its con

36、tainerNote 1 to entry: A label permanently affixed to an IVD instrument is considered marking.ISO 18113-13.9lectinprotein of non-immunogenic origin with two or more binding sites that recognize and bind to specific saccharide residues3.10monoclonal antibodyantibody capable of reacting specifically w

37、ith a single epitope of a certain immunogenic substance3.11polyclonal antibodymixture of immunoglobulin molecules, secreted against a specific immunogenic substance, each recognizing a different epitope3.12stainingimpartment of colour to a material by means of reaction with a stain or chromogenic re

38、agent6DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) 3.13stainsolution of one or more dyes at defined concentrations in a defined solvent used for stainingNote 1 to entry: The stain can be prepared by directly dissolving the dye in the solvent or by dilution of a stock solution with suitable agents.

39、3.14stock solution of stainstable defined solution of one or more dyes at a higher concentration than that used for stainingNote 1 to entry: Stability refers to constant properties of the dye even in the presence of other dyes.3.15nucleic acid probesingle- or double-stranded oligonucleotide or polyn

40、ucleotide of defined length complementary to specific sequences of nucleotides in nucleic acids4 Requirements for information supplied by the manufacturer4.1 General requirements4.1.1 Chain of suppliersWhen a manufacturer uses materials supplied by a producer, the manufacturer has an obligation of a

41、ssuring that the producer meets the quality systems described in ISO 9001 and ISO 13485.4.1.2 Warning and precautionsThe manufacturer of reagents used for staining in biology shall provide information regarding warning and precautions in accordance with ISO 18113-1 and ISO 18113-2.4.1.3 Format of In

42、formation supplied by the manufacturerThe format of the information supplied by the manufacturer with reagents used for staining in biology shall be in accordance with ISO 80000-1 and ISO 80000-9. Furthermore, where relevant, the requirements as specified in 4.1.4, 4.1.5 and 4.1.6 shall be met for t

43、he various reagents used for staining in biology.4.1.4 Information supplied by the manufacturer with reagents used for staining in biologyInformation supplied by the manufacturer with reagents used for staining in biology shall be in accordance with ISO 80000-1 and ISO 80000-9. Information shall be

44、provided regarding warning and precautions. ISO 18113-1 and ISO 18113-2 regarding warnings and precautions apply. Furthermore, where relevant, the requirements as specified in 4.1.2, 4.1.3 and 4.1.4 shall be met for the various reagents used for staining in biology.4.1.5 Product nameThe product name

45、 shall, where relevant, include CAS-registry number 7and Colour Index name and number.23NOTE 1 CAS-registry numbers are the Chemical Abstracts Service registry numbers. These are unique numerical code numbers assigned to chemical substances indexed by Chemical Abstracts.NOTE 2 The Colour Index gives

46、 a 5-digit number, the C.I. number and a specially constructed name to most dyes.7DIN EN ISO 19001:2013-07 EN ISO 19001:2013 (E) 4.1.6 Product identityThe description of the reagent shall include appropriate physico-chemical data accompanied by relevant data sheets for each batch. The data shall con

47、tain the following information:a) the molecular formula including counter-ion;b) the molar mass (g/mol) clearly stating whether this is with or without counter-ion;c) the permissible or allowable limits of interfering substances;d) handling and storage.For coloured organic compounds, the data shall

48、also contain:e) the molar absorbance (this can be substituted by content of the pure dye);f) the wavelength or wave number at maximum absorbance;g) thin layer chromatographic, high performance liquid chromatographic, or high performance thin layer chromatographic data.4.1.7 Suggested useSuggested us

49、e(s) shall be provided giving guidelines for staining in biologyThis shall include information on:a) type(s) of biological material and handling and treatment before staining;NOTE 1 Information on type of biological material and its handling and treatment can be found in Reference.15EXAMPLE Whether cell or tissue samples or both can be used; whether frozen or chemically-fixed material or both can be used; protocol for tissue processing; which embedding