1、Natural rubber latex cleanroom gloves - SpecificationBS ISO 20437:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 20437:2017. The UK participation in its preparation was entrusted to Technical
2、 Committee CH/205/3, Medical gloves.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 Inst
3、itution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93439 1ICS 83.140.99Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendme
4、nts/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS ISO 20437:2017 ISO 2017Natural rubber latex cleanroom gloves SpecificationGants pour salle blanche en latex de caoutchouc naturel - SpcificationsINTERNATIONAL STANDARDISO20437First edition2017-07-15Reference numberISO 20437
5、:2017(E)BS ISO 20437:2017ISO 20437:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll 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 mech
6、anical, 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 officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, Swi
7、tzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 20437:2017ISO 20437:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 26 Sampling 37 Test methods . 37.1 Particle count . 37.2 Ionic content
8、 . 47.3 Total non-volatile residue (TNVR) . 47.4 Silicone, amide and DOP content 48 Processing, packaging and marking 4Bibliography 5 ISO 2017 All rights reserved iiiContents PageBS ISO 20437:2017ISO 20437:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federat
9、ion 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 committe
10、e. 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.The procedures used to develop this document and th
11、ose intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different 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
12、(see www.iso.org/directives).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. Details of any patent rights identified during the development of the do
13、cument will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).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 voluntary nature of standards, t
14、he meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by
15、Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses).iv ISO 2017 All rights reservedBS ISO 20437:2017ISO 20437:2017(E)IntroductionCleanroom gloves have long been used in the critical environments of the electronic, disk drive, semiconductor, as we
16、ll as storage media industries. The quest for a cleaner glove, in new emerging industries of thin-film transistor (TFT), liquid-crystal display (LCD), nanotechnology, bio-medical applications, has ensured that this is a growing market.The basic function of cleanroom gloves is to ensure minimal trans
17、fer of contaminants onto the products or components being processed or manufactured in a clean environment. Such contaminants will always be present in the exposed hands of the personnel. It is for this purpose that the hands need to be gloved. However, such gloves must have minimal contaminants on
18、its surface, thus the need for the use of cleanroom gloves.The principal contaminants that could compromise the quality or the integrity of the product or process in a critical environment are submicron particles, ionic chemical contaminants, non-volatile chemical components, as well as silicone, am
19、ide or dioctyl phthalate (DOP). In the cleanroom industry, these parameters are known as particle count, ionic content, total non-volatile residue (TNVR) and silicone, amide or DOP content.Depending on the criticality of the operational environment, the appropriate cleanroom glove will need to be us
20、ed. Hence, a very critical environment (ISO 4 cleanroom) will need the usage of the cleanest glove, i.e. ISO 4 cleanroom glove. ISO 2017 All rights reserved vBS ISO 20437:2017This page deliberately left blankNatural rubber latex cleanroom gloves - Specification1 ScopeThis document gives the specific
21、ation for ISO 4 , ISO 5 and ISO 6 cleanroom gloves. It is applicable to cleanroom gloves made of natural rubber latex (NRL).2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated r
22、eferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.IEST RP-CC005.4, Gloves and finger cots used in cleanrooms and other controlled environments3 Terms and definitionsFor the purposes of this document, th
23、e following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at http:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/ 3.1cleanroomspecially built room, w
24、ith non-particle releasing as well as non-particle adsorbing floor and wallsNote 1 to entry: The air in circulation is filtered either through high efficiency particulate air (HEPA) or ultra-low particulate air (ULPA) filters. The primary purpose is to introduce as little contaminants as possible on
25、to the workstations, product in progress, as well as personnel in operation, in this room.3.2laminar air flowuniform pattern flow (as opposed to a turbulent flow) of air within the cleanroom (3.1) that ensures all dislodged particles (3.5) are effectively eliminated from the cleanroom3.3reversed osm
26、osis deionized process water RO-DI process waterwater that has very low particles as well as ionic content3.4resistivitymeasure of resistanceNote 1 to entry: Resistivity is expressed in M. It is a measure of the purity of the RO-DI process water (3.3). The best possible purity is 18 M.3.5particleobj
27、ect that is either solid, liquid or both, usually between 1 nm and 1 mm in sizeINTERNATIONAL STANDARD ISO 20437:2017(E) ISO 2017 All rights reserved 1BS ISO 20437:2017ISO 20437:2017(E)3.6generated particleparticle (3.5) not previously present on the surface of a substrate but which is generated and
28、released in response to a mechanical energy imparted on the surface3.7particle sizeapparent maximum linear dimension of a particle (3.5) in the plane of observation as observed with an optical microscope or the equivalent diameter of a particle detected by automatic instrumentation3.8releasable part
29、icleparticle (3.5) present on the surface of a substrate that is readily releasable from the surface by wetting the substrate with a liquid, but without imparting mechanical energy to the substrate3.9airborne particle countnumber of particles (3.5) of size 0,3 m and larger that are present in a typi
30、cal cleanroom (3.1), as determined by an airborne particle counter equipment4 ClassificationThree types of cleanroom gloves are classified:a) ISO 4; b) ISO 5; c) ISO 6. 5 RequirementsNatural rubber latex cleanroom gloves, sampled in accordance with Clause 6, shall meet the requirements specified in
31、Table 1.2 ISO 2017 All rights reservedBS ISO 20437:2017ISO 20437:2017(E)Table 1 Acceptable limit for NRL cleanroom glovesParameters Acceptable limit Test methodISO 6 ISO 5ISO 4 Particle counts20,0 m.The summation of all six ranges above will be the liquid particle count for that glove, reported as c
32、ounts/cm2. ISO 2017 All rights reserved 3BS ISO 20437:2017ISO 20437:2017(E)7.2 Ionic contentRefer to IEST RP-CC005.4, 17.1 to 17.3.7.3 Total non-volatile residue (TNVR)Refer to IEST RP-CC005.4, 17.1, 17.2, 17.5.7.4 Silicone, amide and DOP contentRefer to IEST RP-CC005.4, 17.1. 17.2, 17.4.8 Processin
33、g, packaging and markingThe raw gloves that are compatible for cleanroom processing, need to be laundered, extracted, dried and packed, in a certified cleanroom with laminar air flow in place.NOTE Such processing entails a submicron laundry process, using RO-DI process water of a resistivity within
34、13 M to 18 M, wherein, an interplay of mechanical, temperature, water:glove ratio, contact time as well as frequency of repeat cycles, ensures that the generated particles as well as releasable particles are removed from the surface of the glove, notwithstanding a reduction in the TNVR and ionic con
35、tent. These cleaned gloves are then water extracted and are dried in specialized dryers that have drying air of low airborne particle count.Efforts shall be made to pack these gloves, in special non-particulating packaging. Special markings are indicated to ensure such gloves are not exposed to undu
36、e heat or light source, which may result in further generated particles.4 ISO 2017 All rights reservedBS ISO 20437:2017ISO 20437:2017(E)Bibliography1 ISO 2859-1 , Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspec
37、tion2 ISO 11193-1, Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution3 ISO 14644-1 , Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration4 ISO 14644-6 1), Cleanrooms and ass
38、ociated controlled environments Vocabulary5 ASTM D3577-09, Standard specification for rubber surgical gloves6 ASTM D3578-05, Standard specification for rubber examination gloves7 Classification GMP EU Cleanroom Classification, at rest and in operation 1) Withdrawn. ISO 2017 All rights reserved 5BS I
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