1、BSI Standards PublicationBS ISO 18184:2014Textiles Determination ofantiviral activity of textileproductsBS ISO 18184:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18184:2014.The UK participation in its preparation was entrusted to TechnicalCommittee TCI/
2、80, Chemical testing of textiles.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institutio
3、n 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79901 3ICS 59.080.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2014.Amendments issued s
4、ince publicationDate Text affectedBS ISO 18184:2014 ISO 2014Textiles Determination of antiviral activity of textile productsTextiles Dtermination de lactivit virucide de produits textilesINTERNATIONAL STANDARDISO18184First edition2014-09-01Reference numberISO 18184:2014(E)BS ISO 18184:2014ISO 18184:
5、2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All 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
6、 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 officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgP
7、ublished in SwitzerlandBS ISO 18184:2014ISO 18184:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 25 Virus and host cell . 36 Warning 37 Apparatus . 38 Sterilization of apparatus 69 Reagent and me
8、dium . 610 Preparation .1110.1 Restoration of host cell from cryopreservation .1110.2 Subculture of host cell . 1110.3 Cell culture for the infectious virus titre assay .1210.4 Preparation for test virus 1210.5 Preparation for test specimen 1510.6 Control test 1611 Test procedure .1611.1 Preparation
9、 of specimen1611.2 Inoculation of virus to the specimens 1611.3 Contacting time 1711.4 Wash-out of virus immediately after inoculation 1711.5 Wash-out of virus after contacting time. 1712 Preparation of the series of the dilution for the virus suspension .1713 Infective titre measurement 1813.1 Plaq
10、ue assay . 1813.2 TCID50method . 1814 Calculation of infectivity titre 1814.1 Plaque assay . 1814.2 TCID50method . 1814.3 Test result . 2015 Test report 21Annex A (normative) Virus strains and host cells .22Annex B (normative) Infectivity titre test: Plaque assay 23Annex C (normative) Infectivity ti
11、tre test: TCID50method .26Annex D (normative) Composition of Media .27Annex E (informative) Additional virus: Polio virus .30Annex F (informative) Testing method using SPF embryonated hens eggs .31Annex G (informative) Antiviral efficacy .36Annex H (informative) Round robin test result (1) 37Annex I
12、 (informative) Round robin test result (2) 39Bibliography .42BS ISO 18184:2014ISO 18184:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie
13、d 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. IS
14、O 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 different
15、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 be t
16、he 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).An
17、y 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 in t
18、he Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 38, Textiles.iv ISO 2014 All rights reservedBS ISO 18184:2014ISO 18184:2014(E)IntroductionRecently, along with the global improvement in the level of
19、living, consumers are showing the trend to seek healthcare or health protective products. Also, an increase in the peoples interest for protection against epidemic diseases has been noted, as the overcrowded commuting train car where the commuters experience every day, the hospitals, nursing homes,
20、etc.Being supported by the processing technology of textile products to provide a high performance which has been highly developed recently, the health protective and hygiene relating products have been advancing into the market.Because those products are relatively new products and included the tec
21、hnical aspects out of textile technology, the testing methods have been developed by the individual producers to evaluate the product performance. That has resulted in inexistence of a unified test method, hindering for both consumers and producers a true explanation or understanding of those high f
22、unctional products.The antiviral product is one of those products and includes the technical fields of the textile technology and the biotechnology.The demand to establish the international standard has been growing in the consumers, retailers, producers, etc. as the stakeholders in the market.Antiv
23、iral textile products are textiles capable of reducing the number of infective virus particles that contact the surface of the textile. This standard provides a quantitative test method to assess the antiviral performance of such products.The data obtained in objective manner by this standard give t
24、he common knowledge to all the stake holders such as consumers, producers, retailers, etc. to understand the correct performance of the antiviral textile products.There are two methods to quqntify the number of infective virus, as infective virus titre in this standard, which are the plaque method a
25、nd the TCID50method. The method used can be selected by the experience and the convenience of each testing house. Any appropriate cellular system can be used and that the testing conditions when used should be reported. ISO 2014 All rights reserved vBS ISO 18184:2014BS ISO 18184:2014Textiles Determi
26、nation of antiviral activity of textile products1 ScopeThis International Standard specifies testing methods for the determination of the antiviral activity of the textile products. The textile products include woven and knitted fabrics, fibres, yarns, braids, etc.Viruses used in this International
27、Standard are as follows: one of enveloped viruses, an influenza virus, which is an infective virus in humans that causes respiratory tract infection; one of non-enveloped viruses, a feline calicivirus, which is one of surrogates of noroviruses which are important enteric pathogens.2 Normative refere
28、ncesThe 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 applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO
29、105-F02, Textiles Tests for colour fastness Part F02: Specification for cotton and viscose adjacent fabricsISO 3696, Water for analytical laboratory use Specification and test methodsISO 6330, Textiles Domestic washing and drying procedures for textile testing3 Terms and definitionsFor the purposes
30、of this document, the following terms and definitions apply.3.1virushas no cell and consists of the gene material enclosed by the shell of the protein, it can replicate in the specific host cells3.2virus activityability to replicate in the specific host cells3.3antiviral propertyproperty to give the
31、 morphological change or structural damage to the surface protein of virusNote 1 to entry: As the result, the damaged virus loses the fitting to the receptor of host cell and reduces the virus activity. Depending on the type of molecules the property can also be an alteration of nucleic acids. In ad
32、dition to enveloped viruses there is an alteration of envelope as well.Note 2 to entry: It is not necessarily to imply that the change of antigenic response or the change of constituent element is the reduction of virus infectivity.INTERNATIONAL STANDARD ISO 18184:2014(E) ISO 2014 All rights reserve
33、d 1BS ISO 18184:2014ISO 18184:2014(E)3.4antiviral chemicalsinorganic or organic chemicals able to reduce virus activityNote 1 to entry: The organic antiviral chemicals give the change to the surface protein of virus by the chemical adsorption. The inorganic metallic antiviral substances destroy or c
34、hange the morphology of the virus by the extraction of hydrogen atom in the virus protein by OH radicals which are generated by the radical reaction.3.5reference clothcloth used to verify the stability of the test virus on a textile fabricNote 1 to entry: The 100 % cotton cloth described in ISO 105-
35、F02 should be used without any chemical treatments such as the fluorescent bleach, etc.Note 2 to entry: The fabrics before the antivirus treatment may be used as a reference cloth with the same condition described in 3.5.3.6control test of specimentest to confirm that a specimen does not affect the
36、host cellNote 1 to entry: This test is performed as same as actual test, but without virus.3.7cytopathic effect (CPE) caused by viruseffect appears as morphological change or destruction of the host cells as a result of the virus multiplication3.8infectivity titre of virusnumber of infectious viral
37、particles present per unit volume in a cell lysate or in a solution3.9plaquelysis formed area in a cell monolayer under semisolid medium due to infection by and multiplication of a single infectious virus3.10plaque forming unitsPFUunit expressed as the concentration of the infectious virus per unit
38、volume (ml)3.11plaque assayassay to determine the infectivity titre of virus from PFU by using the series of dilution3.12TCID50method50 % infectious dose of a wash-out virus suspension or the dilution of the virus suspension that induces a CPE in 50 % of cell culture unitsNote 1 to entry: See 3.7.4
39、PrincipleThe viruses are inoculated to a specimen. After specific contacting time, the remaining infectious virus is counted and the reduction rate is calculated by the comparison between the antiviral product test specimen and the reference specimen by common logarithm. There are two methods to qua
40、ntify the infectious virus titre. One method is the plaque assay (3.11) and the other is the TCID50method (3.12) 2 ISO 2014 All rights reservedBS ISO 18184:2014ISO 18184:2014(E)as explained. The selection of the method depends on the convenience and experience of the testing organization.5 Virus and
41、 host cellViruses used in this standard are an Influenza virus and a feline calicivirus which is described in Annex A. Moreover, the host cells are described corresponding to the viruses in Annex A. One or both viruses are chosen for the test depended on the end use of the textile products.6 Warning
42、This standard calls for use of the infectious viruses or substances/procedures that may be injurious to the health/environment if appropriate conditions are not observed. It refers only to technical suitability and does not absolve the user from legal obligations relating to health and safety/enviro
43、nment at any stage.The warning is extended as the following. The virus in the standard shall be the one of biotechnology safety level class II classified by the directives of WHO as stated. The user of this standard shall have enough knowledge and experience of the biotechnology. Moreover, users sha
44、ll comply strictly to the safety standard of the manufacturers and the domestic regulation.7 Apparatus7.1 High pressure steam sterilizer: Autoclave, capable of operating at a temperature of (121 2) C and a pressure of (103 5) kPa.7.2 Dry heat sterilizer: ovens, capable of operating at a temperature
45、of (180 2) C and (160 2) C.7.3 Measuring flask, with capacity of 1 l.7.4 Scale, with the available range of 100 g 0,1 g to 0,01 g 0,000 1 g.7.5 Glass pipette, with capacities of 50 ml 0,5 ml, 25 ml 0,25 ml, 10 ml 0,1 ml and 5 ml 0,05 ml.7.6 Plastic pipette, with capacities of 50 ml 0,5 ml, 25 ml 0,2
46、5 ml, 10 ml 0,1 ml and 5 ml 0,05 ml.7.7 Pipetter, capable of mounting the glass or plastic pipettes or chips.7.8 Micropipette, having the most suitable volume for each use, with a tip made of glass or plastic, and with a tolerance of 0,5 % or less.7.9 Water bath, capable of maintaining at a temperat
47、ure of (37 2) C, (50 2) C or (56 2) C.7.10 Vortex-type mixer, used for microbial testing.7.11 Freezer, capable of operating at a temperature of (80 2) C or (20 2) C.7.12 Liquid nitrogen bath, for the preservation approximately at 196 C.7.13 Membrane filter, with a pore size of 0,22 m.7.14 Refrigerat
48、or, capable of operating at a temperature between (2 2) C and (8 2) C. ISO 2014 All rights reserved 3BS ISO 18184:2014ISO 18184:2014(E)7.15 pH meter, with a glass electrode detector.7.16 Inverted microscope, capable of being used for cultured cells observation.7.17 Tweezers, capable of being sterili
49、zed.7.18 Centrifuge, capable of being operated at a temperature of (4 2)C, and relative centrifugal force of approximately 1 000 g.7.19 Biological safety cabinet, class II.7.20 Vial container, with a capacity of 30 ml and closed with the screw cap. The gasket is made of perfluoroethylene or silicone and the cap is made of polypropylene.7.21 96 wells microplate with the gamma radiation sterilization, for TCID50method.Figure 1 96 wells microplate for TCID50method7.22 6 wells pla
