1、BSI Standards Publication Medical laboratories Reagents for staining biological material Guidance for users PD ISO/TS 17518:2015National foreword This Published Document is the UK implementation of ISO/TS 17518:2015. The UK participation in its preparation was entrusted to Technical Committee CH/212
2、, IVDs. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by
3、BSI Standards Limited 2015 ISBN 978 0 580 89925 6 ICS 11.100.01 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 May 2015. Amendments/corrigenda issued sinc
4、e publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 17518:2015 ISO 2015 Medical laboratories Reagents for staining biological material Guidance for users Laboratoires mdicaux Ractifs pour coloration du matriel biologique Directives pour les utilisateurs TECHNICAL SPECIFICATION ISO/TS 17518
5、 Reference number ISO/TS 17518:2015(E) First edition 2015-04-15 ISO/TS 17518:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means,
6、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 ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20
7、Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO/TS 17518:2015 ISO/TS 17518:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Acquiring reagents for in vitro diagnostic staining in
8、 biology 8 4.1 General principles 8 4.2 Manufacturer name . 8 4.3 Identification of kit components . 8 5 Information associated with the in vitro diagnostic reagent . 8 5.1 Intended use 8 5.2 Instructions for use 9 5.3 Identification of the reagent for staining of biological samples . 9 5.3.1 Reagen
9、t name . 9 5.3.2 Description of IVD reagent for staining of biological samples 10 5.3.3 Batch code 10 5.3.4 Contents 10 5.4 Storage and handling conditions 10 5.5 Expiry date.10 5.6 Warnings and precautions .11 5.7 Additional information for specific kinds of reagents .11 5.7.1 Fluorochromes .11 5.7
10、.2 Metal salts .11 5.7.3 Additional required equipment .11 5.7.4 Reagent preparation 11 5.7.5 Control procedure 11 5.7.6 Interpretation 12 5.7.7 Limitations of the examination procedure .12 5.7.8 Literature references .12 6 V alidation and v erification of biological stains .12 6.1 General Informati
11、on 12 6.2 Validation for the intended use 13 6.3 Verification of the specifications 13 6.4 Certification of biological dyes .13 6.5 Acquisition of biological stains and dyes.13 Annex A (informative) Checklist for establishing or v erifying specifications for biological stains and dyes.14 Bibliograph
12、y .15 ISO 2015 All rights reserved iii Contents Page PD ISO/TS 17518:2015 ISO/TS 17518:2015(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 carri
13、ed 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. I
14、SO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the differen
15、t approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may b
16、e the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents)
17、. Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles
18、 in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information. The committee responsible for this document is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. This Technical Specification addresses the need to use reagents in staini
19、ng in biology that fulfill the criteria of ISO 19001, In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology. This Technical Specification states the requirements for these reagents when used for diagnostic work in medic
20、al laboratory fields such as microbiology, molecular biology, cytology, histopathology, and haematology.iv ISO 2015 All rights reserved PD ISO/TS 17518:2015 ISO/TS 17518:2015(E) Introduction This Technical Specification is based on ISO 19001, In vitro diagnostic medical devices Information supplied
21、by the manufacturer with in vitro diagnostic reagents for staining in biology. It is written for medical laboratories that prepare their own in vitro diagnostic examination procedures from commercially available reagents that are not specifically intended for in vitro diagnostic use, as well as medi
22、cal laboratories that use commercially prepared in vitro diagnostic reagents that are specifically intended for performing in vitro diagnostic examinations. This Technical Specification describes the information that laboratories performing in vitro diagnostic staining in biology need to receive fro
23、m the suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology. It also provides specific guidance for use of this information, which is a prerequisite for professional users in medical laboratories to achieve reproducible and comparable results in
24、all fields of staining in biology. ISO 2015 All rights reserved v PD ISO/TS 17518:2015 Medical laboratories Reagents for staining biological material Guidance for users 1 Scope This Technical Specification provides requirements and guidance for selecting and assessing the quality of reagents to be u
25、sed for in vitro diagnostic staining in biology. This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory discip
26、lines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited
27、applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15189:2012, Medical laboratories Requirements for quality and competence ISO 19001, In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagno
28、stic reagents for staining in biology 3 T erms a nd definiti ons For the purposes of this Technical Specification, the following terms and definitions apply: 3.1 batch lot defined amount of material that is uniform in its properties and has been produced in one process or series of processes SOURCE:
29、 ISO 18113-1 3.2 batch code lot number distinctive set of numbers and/or letters that specifically identifies a batch and permits its manufacturing, packaging, labelling and distribution history to be traced SOURCE: ISO 18113-1 3.3 blocking reagent reagent that is used before staining to reduce the
30、inherent background of a sample SOURCE: ISO 19001:2013, 3.2, Definition has been reworded to improve clarity. TECHNICAL SPECIFICATION ISO/TS 17518:2015(E) ISO 2015 All rights reserved 1 PD ISO/TS 17518:2015 ISO/TS 17518:2015(E) 3.4 chromogenic reagent reagent that reacts with certain chemical groups
31、, present or induced, in cells and tissues with the formation of a coloured compound in situ EXAMPLE Diazonium salt; Schiffs reagent. SOURCE: ISO 19001 3.5 component part of a finished, packaged and labelled IVD medical device EXAMPLE raw material, substance, piece, part, software, firmware or label
32、ling. Note 1 to entry: Typical kit components include antibody solutions, buffer solutions, calibrators, and/or control materials. SOURCE: ISO 18113-1 3.6 control material substance, material or article intended by its manufacturer to be used to verify the performance properties of an IVD medical de
33、vice Note 1 to entry: For staining in biology, control material may also include previously diagnosed patient samples (cellular or tissue). SOURCE: ISO 18113-1:2009, 3.13, The term performance characteristics has been changed to performance properties. 3.7 dye coloured organic compound that, when di
34、ssolved in a suitable solvent, can impart colour to a material SOURCE: ISO 19001 3.8 examination set of operations having the purpose of determining the value or characteristics of a property Note 1 to entry: In some disciplines (e.g. microbiology), an examination can be the total activity of severa
35、l examinations. SOURCE: ISO 18113-1:2009, 3.16, Note 1 to entry has been modified for clarity. 3.9 expiry date expiration date upper limit of the time interval during which the performance properties of a material stored under specified conditions can be assured SOURCE: ISO 18113-1:2009, 3.17, The t
36、erm performance characteristics has been changed to performance properties. 3.10 f l u o ro chro m e reagent that emits visible light when irradiated with excitation light of a shorter wavelength SOURCE: ISO 190012 ISO 2015 All rights reserved PD ISO/TS 17518:2015 ISO/TS 17518:2015(E) 3.11 hazard po
37、tential source of harm SOURCE: ISO/IEC Guide 51:1999 3.12 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
38、 description, and use of the IVD medical device, but excluding shipping documents EXAMPLE Labels, instructions for use. SOURCE: ISO 18113-1 3.13 instructions for use information supplied by the manufacturer to enable the safe and proper use of an IVD medical device Note 1 to entry: Includes warnings
39、, precautions, and directions supplied by the manufacturer for the use, maintenance, troubleshooting and disposal of an IVD medical device. SOURCE: ISO 18113-1 3.14 intended use intended purpose objective intent of an IVD manufacturer or the laboratory user regarding the use of a product, process or
40、 service as reflected in the specifications, instructions and information supplied by the IVD manufacturer or specified by the laboratory user SOURCE: ISO 18113-1:2009, 3.31, Definition has been expanded to include intent of laboratory users. 3.15 in vitro diagnostic medical device IVD medical devic
41、e device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of primary samples derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes including reagents, calibrators, control material
42、s, specimen receptacles, software, and related instruments or apparatus or other articles SOURCE: ISO 18113-1 3.16 in vitro diagnostic reagent IVD reagent chemical, biological or immunological components, solutions or preparations intended by the manufacturer to be used as an IVD medical device SOUR
43、CE: ISO 18113-1 ISO 2015 All rights reserved 3 PD ISO/TS 17518:2015 ISO/TS 17518:2015(E) 3.17 kit set of components that are packaged together and intended to be used to perform one or more specific IVD examinations Note 1 to entry: Kit components can include reagents (such as antibodies, enzymes, b
44、uffer and diluents), calibrators, controls and other articles and materials. SOURCE: ISO 18113-1 3.18 label printed, written, or graphic information placed on a medical device or its container SOURCE: ISO 18113-1 3.19 lectin protein of non-immunogenic origin with two or more binding sites that recog
45、nize and bind to specific saccharide residues SOURCE: ISO 19001 3.20 manufacturer natural or legal person responsible for the design, manufacture, fabrication, assembly, packaging or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market an
46、d/or put into service, regardless of whether these operations are carried out by that person or on his or her behalf by a third party SOURCE: ISO 18113-1 3.21 medical device instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other sim
47、ilar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an inju
48、ry, investigation, replacement, modification or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of primary samples derived from the
49、 human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which can be assisted in its intended function by such means Note 1 to entry: The concept medical device includes in vitro diagnostic medical device. SOURCE: ISO 18113-1:2009, 3.47, Note 1 to entry has been added for emphasis.4 ISO 2015 All rights reserved PD ISO/TS 17518:2015 ISO/TS 17518:2015(E) 3.22 precaution
