BS ISO 25518-2009 Single-use rubber gloves for general applications - Specification《一般用途一次性使用橡胶手套 规范》.pdf

1、BS ISO25518:2009ICS 13.340.40; 83.140.99NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSingle-use rubbergloves for generalapplications SpecificationThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November

2、2009. BSI 2009ISBN 978 0 580 57105 3Amendments/corrigenda issued since publicationDate CommentsBS ISO 25518:2009National forewordThis British Standard is the UK implementation of ISO 25518:2009.The UK participation in its preparation was entrusted to TechnicalCommittee CH/205/3, Medical gloves.A lis

3、t of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal ob

4、ligations.BS ISO 25518:2009Reference numberISO 25518:2009(E)ISO 2009INTERNATIONAL STANDARD ISO25518First edition2009-09-15Single-use rubber gloves for general applications Specification Gants en caoutchouc usages gnraux, non rutilisables Spcifications BS ISO 25518:2009ISO 25518:2009(E) PDF disclaime

5、r This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accep

6、t therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the fi

7、le; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED

8、 DOCUMENT ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member

9、 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 copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reservedBS ISO 25518:2009ISO 25518:2009(E) ISO 2009 All rights reserved i

10、iiForeword 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

11、 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 matte

12、rs 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 circula

13、ted 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 responsibl

14、e for identifying any or all such patent rights. ISO 25518 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses). BS ISO 25518:2009BS ISO 25518:2009INTERNATIONAL STANDARD ISO 25518:2009(E) ISO 2009 All rights reserved 1Single-use ru

15、bber gloves for general applications Specification WARNING Persons using this International Standard should be familiar with normal laboratory practices. This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to est

16、ablish appropriate safety and health practices and to ensure compliance with any regulatory conditions. 1 Scope This International Standard specifies the physical requirements and methods of sampling and testing for single-use rubber gloves, made from natural rubber latex, synthetic rubber latex or

17、rubber solution, intended for general applications, but not gloves intended for medical purposes. It does not cover the safe and proper usage of the gloves. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only th

18、e edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 37, Rubber, vulcanized or thermoplastic Determination of tensile stress-strain properties ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat re

19、sistance tests ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection 3 Requirements 3.1 Materials Gloves shall be manufactured from suitable materials. Any pigment, surface treatment, lubricant or pow

20、der used shall be non-toxic and shall be disclosed on request. Substances used for the treatment that could be transferred to the skin during use shall not cause any harm. 3.2 Dimensions When measured at the points shown in Figure 1, gloves shall comply with the dimensions for length and palm width

21、given in Table 1, using the inspection level and AQL given in Table 3. The measurement of length shall be the shortest distance between the tip of the second finger and the cuff end. The length measurement may be taken by hanging the glove on a suitable mandrel with a tip radius of 5 mm. The measure

22、ment of width shall be at the midpoint between the base of the index finger and the base of the thumb. The width measurement shall be made with the glove placed on a flat surface. BS ISO 25518:2009ISO 25518:2009(E) 2 ISO 2009 All rights reservedKey l length of glove w width of glove Figure 1 Measure

23、ment points for width and length of the glove Table 1 Dimensions and tolerances Size Width (dimension w in Figure 1) mm Minimum length (dimension l in Figure 1) mm Extra small (XS) u 80 220 Small (S) 80 10 220 Medium (M) 95 10 230 Large (L) 110 10 230 Extra large (XL) W 110 230 BS ISO 25518:2009ISO

24、25518:2009(E) ISO 2009 All rights reserved 33.3 Watertightness When gloves are tested for watertightness as described in Annex A, the sample size and allowable number of non-conforming (i.e. leaking) gloves in the sample shall be determined in accordance with the inspection level and AQL given in Ta

25、ble 3. 3.4 Tensile properties 3.4.1 General Tensile properties shall be measured in accordance with ISO 37, taking three type 2 dumb-bell test pieces from each glove and using the median value as the test result. Test pieces shall be taken from the palm or back of the gloves. 3.4.2 Force at break an

26、d elongation at break When determined in accordance with the method specified in ISO 37, using type 2 dumb-bell test pieces, the force at break and elongation at break shall comply with the requirements given in Table 2, using the inspection level and AQL given in Table 3. Table 2 Tensile properties

27、 Property Requirement Minimum force at break before accelerated ageing, N 7,0 Minimum elongation at break before accelerated ageing, % 500 Minimum force at break after accelerated ageing, N 6,0 Minimum elongation at break after accelerated ageing, % 400 3.5 Accelerated ageing Accelerated ageing shal

28、l be conducted in accordance with the method specified in ISO 188. Test pieces can be prepared either by ageing the gloves at 70 C 2 C for 168 h 2 h or at 100 C 2 C for 22 h and cutting the test pieces from the aged gloves, or by cutting the test pieces from unaged gloves and ageing the test pieces

29、at 70 C 2 C for 168 h 2 h or at 100 C 2 C for 22 h. Tensile testing is then conducted as described in 3.4. The results shall comply with the requirements given in Table 2, using the inspection level and AQL as in Table 3. 4 Sampling and inspection For referee purposes, gloves shall be sampled and in

30、spected in accordance with ISO 2859-1. The inspection levels and acceptance quality limits (AQLs) shall conform to those specified in Table 3 for the characteristics listed. When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed. Table 3 Inspection levels and AQLs Characte

31、ristic Inspection level AQL Physical dimensions (width, length) S-2 6,5 Watertightness S-4 4,0 Force at break and elongation at break S-2 6,5 BS ISO 25518:2009ISO 25518:2009(E) 4 ISO 2009 All rights reserved5 Labelling 5.1 Use of symbols Appropriate international symbols may be used for marking purp

32、oses in addition to the wording given in 5.2. The language used for marking shall be as agreed upon between the interested parties. 5.2 Marking Packages intended to facilitate safe transport and storage of the gloves shall be clearly marked with the following: a) the name or trademark of the manufac

33、turer or supplier; b) the material used; c) the words “TEXTURED” or “SMOOTH”, “PRE-POWDERED” or “POWDER-FREE”, or words to that effect for the appropriate glove finish; d) the size, as specified in Table 1; e) the manufacturers identifying lot number; f) the words “DATE OF MANUFACTURE”, or words to

34、that effect, and the year (in four digits) and month of manufacture; g) the approximate number of gloves; h) instructions for storage; i) the words “NOT FOR MEDICAL OR INDUSTRIAL USE”, or words to that effect. BS ISO 25518:2009ISO 25518:2009(E) ISO 2009 All rights reserved 5Annex A (normative) Test

35、for watertightness A.1 Apparatus A.1.1 Circular hollow mandrel, of minimum external diameter 60 mm and adequate length to hold the glove and, with the glove attached, to accommodate 1 000 cm3of water. An example is given in Figure A.1. NOTE A transparent circular hollow mandrel would be suitable. Di

36、mensions in millimetres Key 1 hook 2 cylinder 3 score line on inside surface of wall Figure A.1 Mandrel BS ISO 25518:2009ISO 25518:2009(E) 6 ISO 2009 All rights reservedA.1.2 Holding device, designed to hold the glove in the vertical position when filled with water. An example is given in Figure A.2

37、. Figure A.2 Holding device A.1.3 Graduated cylinder, capacity of at least 1 000 cm3, or other dispensing apparatus capable of delivering 1 000 cm3of water at a time. A.2 Procedure Attach the glove to the circular hollow mandrel with a suitable device, e.g. an O-ring, so that the glove does not exte

38、nd more than 40 mm over the mandrel. Introduce 1 000 cm3 50 cm3of water at a maximum temperature of 36 C into the hollow mandrel. Remove water that has inadvertently splashed onto the outside of the glove. If the water does not rise to within 40 mm of the cuff end, raise the glove to ensure that the

39、 whole of the glove, excluding the part 40 mm from the cuff end, is tested. Note any leaks immediately evident. If the glove does not leak immediately, make a second observation for leaks 2 min to 4 min after pouring the water into the glove. Disregard leakage within 40 mm of the cuff end. To assist

40、 observation, the water may be coloured with a water-soluble dye. BS ISO 25518:2009BS ISO 25518:2009ISO 25518:2009(E) ICS 83.140.99 Price based on 6 pages ISO 2009 All rights reserved BS ISO 25518:2009This page has been intentionally left blank BS ISO25518:2009BSI GroupHeadquarters 389Chiswick High

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