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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12376:1999 The Euro
2、pean Standard EN 12376:1999 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology Licensed Copy: she
3、ffieldun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 1999
4、BSI 07-1999 ISBN 0 580 30594 5 BS EN 12376:1999 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the English language version of EN 12376:1999. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic s
5、ystems, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them i
6、n the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitl
7、ed International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance wi
8、th a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 11 and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrol
9、led Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref
10、. No. EN 12376:1999 E EUROPEAN STANDARDEN 12376 NORME EUROPE ENNE EUROPA ISCHE NORM January 1999 ICS 11.100 Descriptors: medicine, biology, in-vitro diagnostic, chemical reagents, coloration, definitions, information, labelling English version Invitro diagnostic medical devices Information supplied
11、by the manufacturer with invitro diagnostic reagents for staining in biology Dispositifs me dicaux de diagnostic in vitro Informations fournies par le fabricant de re actifs de coloration de diagnostic in vitro ustilise ses en biologie In-vitro-Diagnostika Bereistellung von Informationen durch den H
12、ersteller von in-vitro-Diagnostika-Reagenzien fu r biologische Fa rbungen This European Standard was approved by CEN on 27 August 1998. 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
13、standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any oth
14、er language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, G
15、reece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12376:1999 BSI 07-1999 Foreword This European Standard has be
16、en prepared by 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 July 1999, and conflict
17、ing national standards shall be withdrawn at the latest by July 1999. Annexes A and B are given for information. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech R
18、epublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Terms and definitions3 3.1information supplied by the manuf
19、acturer3 3.2label3 3.3in vitro diagnostic3 3.4staining3 3.5dye3 3.6stain3 3.6.1 stock solution of stain3 3.7chromogenic reagent4 3.8fluorochrome4 3.9antibody4 3.9.1 polyclonal antibody4 3.9.2 monoclonal antibody4 3.10 nucleic acid probe4 3.11 lectin4 4Requirements for information supplied by the man
20、ufacturer4 4.1General requirements4 4.1.1 Information supplied by the manufacturer with reagents used for staining in biology4 4.1.2 Product name4 4.1.3 Description of reagent4 4.1.4 Intended use4 4.2Additional requirements for specific kinds of reagents5 4.2.1 Fluorochromes5 4.2.2 Metal salts5 4.2.
21、3 Antibodies5 4.2.4 Nucleic acid probes5 Annex A (informative) Examples of information supplied by the manufacturer with reagents commonly used in biological staining procedures6 A.1Methyl Green-Pyronin Y stain6 A.2Feulgen-Schiff reaction7 A.3Immunohistochemical demonstration of oestrogen receptors8
22、 A.4Flow cytometric demonstration of T-cells10 Annex B (informative) Bibliography11 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12376:1999 BSI 07-1999 Introduction This European Standard relates to EN 375, In vitro diagnostic s
23、ystems Requirements for labelling of in vitro diagnostic reagents for professional use and EN 376, In vitro diagnostic systems Requirements for labelling of in vitro diagnostic reagents for self testing and should be used in conjunction with these. The use of reagents required for staining in biolog
24、y as well as the specific examples of information supplied by the manufacturer for four 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 to assist manufacturers, sup
25、pliers, and vendors of dyes, stains, chromogenic reagents, and other reagents used for staining in biology in complying with the required specific product data. 1 Scope This European Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biolog
26、y. It applies to producers, suppliers, and vendors of dyes, stains, chromogenic reagents, and other reagents used for staining in biology. The requirements for information supplied by the manufacturer specified in this European Standard are a prerequisite for achieving comparable and reproducible re
27、sults in all fields of staining in biology. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated r
28、eferences, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 375, In vitro diagnostic systems Requirements for
29、labelling of in vitro diagnostic reagents for professional use. EN 376, In vitro diagnostic systems Requirements for labelling of in vitro diagnostic reagents for self testing. ISO 31-8, Quantities and units Part 8: Physical chemistry and molecular physics. ISO 1000, SI units and recommendations for
30、 the use of their multiples and of certain other units. 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 information supplied by the manufacturer all printed, written, graphic or other information affixed to, or accompanying an in vit
31、ro diagnostic reagent 3.2 label any printed, written or graphic information placed on a container EN 375 3.3 in vitro diagnostic reagent reagent that, used alone or in combination with other in vitro diagnostic medical devices, is intended by the manufacturer to be used in vitro for examination of s
32、ubstances derived from human, animal or plant sources, for providing information relevant to the detection, diagnosis, monitoring or treatment of physiological states, states of health or disease, or congenital abnormality 3.4 staining impartment of colour to a material by means of reaction with a s
33、tain or chromogenic reagent 3.5 dye coloured organic compound that, when dissolved in a suitable solvent, can impart colour to a material NOTEThe physical origin of colour is the selective absorbance (and/or emission) in the visible region of the electromagnetic spectrum between 400 nm and 800 nm. D
34、yes are molecules with large systems of delocalized electrons (conjugated -electronic system). The light absorbance characteristics of dyes are displayed by absorbance spectra, resulting from plotting absorbance of light against wavelength. The shape of the spectra and the wavelength at maximum abso
35、rbance depend on the chemical structure of the dye, the solvent, and on the conditions of the spectral measurements. 3.6 stain solution of one or more dyes at defined concentrations in a defined solvent used for staining NOTEThe stain can be prepared by directly dissolving the dye in the solvent or
36、by dilution of a stock solution with suitable agents. 3.6.1 stock solution of stain stable defined solution of one or more dyes at a higher concentration than that employed for staining NOTEStability refers to constant properties of the dye even in the presence of other dyes. Licensed Copy: sheffiel
37、dun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12376:1999 BSI 07-1999 3.7 chromogenic reagent reagent that reacts with certain chemical groups present or induced in cells and tissues with the formation of a coloured compound in situ EXAMPLE Typical chro
38、mogenic reagents are: a) diazonium salts; b) Schiffs reagent. 3.8 fluorochrome reagent which emits visible light when irradiated with excitation light of a shorter wavelength 3.9 antibody specific immunoglobulin formed by B-lymphocytes in response to exposure to an immunogenic substance and able to
39、bind to this NOTEThe molecule of an immunogenic substance contains one or more parts with a characteristic chemical composition, an epitope. 3.9.1 polyclonal antibody mixture of antibodies capable of reacting specifically with a certain immunogenic substance 3.9.2 monoclonal antibody antibody capabl
40、e of reacting specifically with a single epitope of a certain immunogenic substance 3.10 nucleic acid probe single stranded oligonucleotide or polynucleotide of defined length complementary to specific sequences of nucleotides in nucleic acids 3.11 lectin protein of non-immunogenic origin with two o
41、r more binding sites that recognize and bind to specific saccharide residues 4 Requirements for information supplied by the manufacturer 4.1 General requirements 4.1.1 Information supplied by the manufacturer with reagents used for staining in biology Information supplied by the manufacturer with re
42、agents used for staining in biology shall conform with EN 375, EN 376, ISO 31-8, and ISO 1000. Special attention shall be given to cautionary statements as given in EN 375. 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
43、 for staining in biology. 4.1.2 Product name The product name shall include, CAS-registry number and Colour Index name and number, where applicable. NOTE 1CAS-registry numbers are the Chemical Abstracts Service registry numbers. These are unique numerical code numbers assigned to chemical substances
44、 indexed by Chemical Abstracts. NOTE 2The Colour Index gives a 5-digit number, the C.I. number and a specially constructed name to most dyes. 4.1.3 Description of reagent The description of the reagent shall include appropriate physico-chemical data accompanied by relevant data sheets for each batch
45、. The data shall contain as a minimum: a) the molecular formula including counter-ion; b) the molar mass (gmol21) clearly stating whether this is with or without counter-ion; c) the allowable limits of interfering substances. For coloured organic compounds, the data shall also contain: d) the molar
46、absorbance (this can be substituted by content of the pure dye molecule but not by content of total dye); e) the wavelength or wavenumber at maximum absorbance; f) thin layer chromatographic, high performance liquid chromatographic, or high performance thin layer chromatographic data. 4.1.4 Intended
47、 use A description shall be provided giving guidelines for staining in biology and for qualitative and quantitative procedures (if applicable). This shall include information on: a) type(s) of biological material and handling and treatment before staining, for example: whether cell or tissue samples
48、 or both can be used; whether frozen or chemically fixed material or both can be used; protocol for tissue processing; which embedding media can be used; b) details of a suitable reaction procedure used by the manufacturer for testing the reactivity of the dye, stain, chromogenic reagent, fluorochro
49、me, antibody, nucleic acid probe, or lectin used for staining in biology; c) result(s) expected when using the reaction procedure on the suggested type(s) of material in the way outlined by the manufacturer; d) notes on suitable positive and negative control tissue and on interpretation of the result(s); e) references to published results using the product in the way suggested by the manufacturer. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12376:1999 BSI 07-
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