SIST EN ISO 19001:2013

SLOVENSKI STANDARD
SIST EN ISO 19001:2013
01-junij-2013
1DGRPHãþD
SIST EN 12376:2000
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHNLMLKSULVNUELSURL]YDMDOHF
GLDJQRVWLþQLKUHDJHQWRY]DEDUYDQMHLQYLWURYELRORJLML,62
In vitro diagnostic medical devices - Information supplied by the manufacturer with in
vitro diagnostic reagents for staining in biology (ISO 19001:2013)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-
diagnostischen Reagenzien für biologische Färbungen (ISO 19001:2013)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant avec
les réactifs de coloration de diagnostic in vitro utilisés en biologie (ISO 19001:2013)
Ta slovenski standard je istoveten z: EN ISO 19001:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 19001:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19001:2013

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SIST EN ISO 19001:2013


EUROPEAN STANDARD
EN ISO 19001

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2013
ICS 11.100.10; 11.040.55 Supersedes EN 12376:1999
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer with in vitro diagnostic reagents for staining in
biology (ISO 19001:2013)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant avec les réactifs de coloration de durch den Hersteller von in-vitro-diagnostischen
diagnostic in vitro utilisés en biologie (ISO 19001:2013) Reagenzien für biologische Färbungen (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 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, Former Yugoslav 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
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19001:2013: E
worldwide for CEN national Members.

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SIST EN ISO 19001:2013
EN ISO 19001:2013 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 19001:2013
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 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 September 2013, and conflicting national standards shall 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.
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, Germany, 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 19001:2013 without any modification.

3

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SIST EN ISO 19001:2013

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SIST EN ISO 19001:2013
INTERNATIONAL ISO
STANDARD 19001
Second edition
2013-03-15
In vitro diagnostic medical devices —
Information supplied by the
manufacturer with in vitro diagnostic
reagents for staining in biology
Dispositifs médicaux de diagnostic in vitro — Informations fournies
par le fabricant avec les réactifs de coloration de diagnostic in vitro
utilisés en biologie
Reference number
ISO 19001:2013(E)
©
ISO 2013

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SIST EN ISO 19001:2013
ISO 19001:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested 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 2013 – All rights reserved

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SIST EN ISO 19001:2013
ISO 19001:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for information supplied by the manufacturer . 3
4.1 General requirements . 3
4.2 Additional requirements for specific kinds of reagent . 4
Annex A (informative) Examples of information supplied by the manufacturer with reagents
commonly used in biological staining procedures . 7
Bibliography .13
© ISO 2013 – All rights reserved iii

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SIST EN ISO 19001:2013
ISO 19001:2013(E)

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 19001 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
This second edition cancels and replaces the first edition (ISO 19001:2002), which has been
technically revised.
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SIST EN ISO 19001:2013
ISO 19001:2013(E)

Introduction
This 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 information 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, chromogenic reagents and other
reagents used for staining in biology in complying with the required specific product data.
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SIST EN ISO 19001:2013

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SIST EN ISO 19001:2013
INTERNATIONAL STANDARD ISO 19001:2013(E)
In vitro diagnostic medical devices — Information supplied
by the manufacturer with in vitro diagnostic reagents for
staining in biology
1 Scope
This International Standard specifies requirements for information supplied by the manufacturer
with reagents used in staining 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 requirements 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 references
The following referenced documents are indispensable for the application of this 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: General
ISO 80000-9, Quantities and units — Part 9: Physical chemistry and molecular physics
ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 1: Terms, definitions and general requirements
ISO 18113-2, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 2: In vitro diagnostic reagents for professional use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
antibody
specific immunoglobulin formed by B-lymphocytes in response to exposure to an immunogenic
substance and able to bind to this
Note 1 to entry: The molecule of an immunogenic substance contains one or more parts with a characteristic
chemical configuration, an epitope.
3.2
blocking reagent
reagent that is used to reduce the inherent background of a sample before staining
3.3
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 Diazonium salt, Schiff’s reagent.
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ISO 19001:2013(E)

3.4
dye
coloured organic compound that, when dissolved in a suitable solvent, can impart colour to a material
3.5
fluorochrome
reagent that emits visible light when irradiated with excitation light of a shorter wavelength
Note 1 to entry: Any of various fluorescent substances used in biological staining to produce fluorescence in a sample.
3.6
in vitro diagnostic reagent
IVD reagent
chemical, biological or immunological component, solution or preparation intended by the manufacturer
to be used as an IVD medical device
[ISO 18113-1]
3.7
information supplied by the manufacturer
labelling
written, 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, technical description, and use of the IVD medical device, but excluding
shipping documents
EXAMPLE Labels, instructions for use.
Note 1 to entry: Catalogues are not considered labelling of IVD medical devices.
[ISO 18113-1]
3.8
label
printed, written or graphic information placed on a medical device or its container
Note 1 to entry: A label permanently affixed to an IVD instrument is considered marking.
[ISO 18113-1]
3.9
lectin
protein of non-immunogenic origin with two or more binding sites that recognize and bind to specific
saccharide residues
3.10
monoclonal antibody
antibody capable of reacting specifically with a single epitope of a certain immunogenic substance
3.11
polyclonal antibody
mixture of immunoglobulin molecules, secreted against a specific immunogenic substance, each
recognizing a different epitope
3.12
staining
impartment of colour to a material by means of reaction with a stain or chromogenic reagent
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3.13
stain
solution of one or more dyes at defined concentrations in a defined solvent used for staining
Note 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.
3.14
stock solution of stain
stable defined solution of one or more dyes at a higher concentration than that used for staining
Note 1 to entry: Stability refers to constant properties of the dye even in the presence of other dyes.
3.15
nucleic acid probe
single- or double-stranded oligonucleotide or polynucleotide of defined length complementary to
specific sequences of nucleotides in nucleic acids
4 Requirements for information supplied by the manufacturer
4.1 General requirements
4.1.1 Chain of suppliers
When a manufacturer uses materials supplied by a producer, the manufacturer has an obligation of
assuring that the producer meets the quality systems described in ISO 9001 and ISO 13485.
4.1.2 Warning and precautions
The 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 Information supplied by the manufacturer
The 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 the various reagents used for staining in biology.
4.1.4 Information supplied by the manufacturer with reagents used for staining in biology
Information 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 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 name
[7]
The product name shall, where relevant, include CAS-registry number and Colour Index name and
[23]
number.
NOTE 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 a 5-digit number, the C.I. number and a specially constructed name to most dyes.
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4.1.6 Product identity
The description of the reagent shall include appropriate physico-chemical data accompanied by relevant
data sheets for each batch. The data shall contain 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 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 use
Suggested use(s) shall be provided giving guidelines for staining in biology
This 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
[15]
Reference.
EXAMPLE 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 media can be used.
[15]
NOTE 2 Reference gives procedures for use in the testing of dye, stain, chromogenic reagent,
fluorochrome, antibody and nucleic acid probe used for staining in biology.
b) details of a suitable reaction procedure used by the manufacturer for testing the reactivity of
the dye, stain, chromogenic reagent, fluorochrome, 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 detailed by the manufacturer;
EXAMPLES See A.2 and A.3.
d) notes on suitable positive and negative control tissue and on interpretation of the result(s);
e) references to published results obtained using the product in the way suggested by the manufacturer.
4.2 Additional requirements for specific kinds of reagent
4.2.1 Fluorochromes
Independent of the type of application, fluorochromes offered for staining in biology shall be accompanied
by the following information:
a) selectivity, i.e. a description of the target(s) which may be demonstrated using the conditions specified;
b) excitation and emission wavelengths;
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c) for fluorochromes conjugated to antibodies, the amount-of-substance
...