1、 Reference number ISO 11193-1:2008(E) ISO 2008INTERNATIONAL STANDARD ISO 11193-1 Second edition 2008-09-01 Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution Gants en caoutchouc pour examen, non rutilisables Partie 1: Spcifications pour g
2、ants fabriqus partir de latex de caoutchouc ou dune solution de caoutchouc ISO 11193-1:2008(E) PDF disclaimer 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 a
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5、lating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 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 p
6、hotocopying and microfilm, without permission in writing 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 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in
7、Switzerland ii ISO 2008 All rights reservedISO 11193-1:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Classification. 2 4 Materials 2 5 Sampling and selection of test pieces 3 6 Requirements 3 7 Packaging 6 8 Marking 6 Annex A (normative)
8、Test for watertightness . 8 ISO 11193-1:2008(E) iv ISO 2008 All rights reservedForeword 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 I
9、SO 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
10、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.
11、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 d
12、ocument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11193-1 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses). This second edition cancels and replace
13、s the first edition (ISO 11193-1:2002), of which it constitutes a minor revision intended to incorporate the Technical Corrigendum ISO 11193-1:2002/Cor.1:2005 and the Amendment ISO 11193-1:2002/Amd.1:2007. In addition, the normative references have been updated. ISO 11193 consists of the following p
14、arts, under the general title Single-use medical examination gloves: Part 1: Specification for gloves made from rubber latex or rubber solution Part 2: Specification for gloves made from poly(vinyl chloride) INTERNATIONAL STANDARD ISO 11193-1:2008(E) ISO 2008 All rights reserved 1 Single-use medical
15、 examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution 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.
16、 It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any regulatory conditions. 1 Scope This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examination
17、s and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over all or part of the glove. This part of ISO
18、11193 is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures. 2 Normative references The following referenced doc
19、uments 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 37, Rubber, vulcanized or thermoplastic Determination of tensile stress-s
20、train properties ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance 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 ISO 10993 (all parts), Biological evalu
21、ation of medical devices ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 23529, Rubber General procedures for preparing and conditioning test pieces for physical test methods ISO 11193-1:2008(E) 2 ISO 2008 All rights reserved3 Cl
22、assification 3.1 General Gloves are classified by type and finish, as given in 3.2 and 3.3. 3.2 Type Two types are classified: a) type 1: gloves made primarily from natural rubber latex; b) type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubbe
23、r solution, styrene-butadiene rubber emulsion or thermoplastic-elastomer solution. 3.3 Finish Four finishes are classified: a) textured surface over part or all of the gloves; b) smooth surface; c) powdered surface; d) powder-free surface. NOTE 1 Powdered gloves are gloves where a powder has been ap
24、plied on the gloves as a part of the manufacturing process, generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate application of powdered materials. Powder-free is also referred to as “powderless”, “no powder” or “non- powdered”, or other
25、words to that effect. NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim. 4 Materials Gloves shall be manufactured from compounded natural rubber or nitrile rubber or polychloroprene rubber latex, or compounded styrene-butadiene rubber or thermoplastic-elastomer solut
26、ion, or compounded styrene- butadiene rubber emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or polymer coating may be used subject to compliance with ISO 10993. Any pigment used shall be non-toxic. It is essential that substances used for surface treatment which
27、 are capable of being transferred are bio-absorbable. Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall make available to the purchaser, on request, data to support compliance with these requirements. NOTE 1 Other suitable polymeric materials
28、may be included in future parts of ISO 11193. NOTE 2 It is recognized that some individuals may, over a period of time, become sensitized to a particular rubber compound (allergic reaction) and require gloves of an alternative formulation. NOTE 3 Limits of extractable proteins, allergenic proteins,
29、residual chemicals, endotoxins and residual powder in gloves may be specified in future editions of this part of ISO 11193, subject to the availability of relevant ISO standard test methods. ISO 11193-1:2008(E) ISO 2008 All rights reserved 3 5 Sampling and selection of test pieces 5.1 Sampling For r
30、eferee purposes, gloves shall be sampled and inspected in accordance with ISO 2859-1. The inspection levels and acceptance quality limits (AQLs) shall conform to those specified in Table 1 for the characteristics listed. When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assum
31、ed. Table 1 Inspection levels and AQLs Characteristic Inspection level AQL Physical dimensions (width, length, thickness) S-2 4,0 Watertightness G-I 2,5 Force at break and elongation at break (before and after accelerated ageing) S-2 4,0 5.2 Selection of test pieces Where test pieces are required, t
32、hey shall be taken from the palm or back of gloves. 6 Requirements 6.1 Dimensions When measured at the points shown in Figure 1, gloves shall comply with the dimensions for palm width and length given in Table 2, using the inspection level and AQL given in Table 1. The measurement of length shall be
33、 the shortest distance between the tip of the second finger and the cuff termination. The length measurement may be taken by hanging the glove on a suitable mandrel with a tip radius of 5 mm. The measurement of width shall be at the midpoint between the base of the index finger and the base of the t
34、humb. The width measurement shall be made with the glove placed on a flat surface. The thickness of the double wall of an intact glove shall be measured in accordance with ISO 23529, with a pressure on the foot of 22 kPa 5 kPa, at each of the locations shown in Figure 2: at a point 13 mm 3 mm from t
35、he extreme tip of the second finger and at the approximate centre of the palm. The single-wall thickness at each point shall be reported as half the measured double-wall thickness and shall comply with the dimensions given in Table 2, using the inspection level and AQL given in Table 1. If visual in
36、spection indicates the presence of thin spots, then single-wall thickness measurements shall be made in such areas. The thickness at the smooth area and textured area of a single wall when measured as described in this subclause shall not be less than 0,08 mm and 0,11 mm, respectively. The thickness
37、 of the cuff termination, measured in accordance with ISO 23529, should preferably not exceed 2,50 mm. ISO 11193-1:2008(E) 4 ISO 2008 All rights reservedFigure 1 Measurement points for the width and length of the glove Table 2 Dimensions and tolerances Size code Width corresponding to size code (dim
38、ension w, Figure 1) Descriptive size Width corresponding to descriptive size (dimension w, Figure 1) Minimum length (dimension l, Figure 1) Minimum thickness (at locations shown in Figure 2) Maximum thickness (at approximate centre of palm) mm mm mm mm mm 6 and below u 82 Extra small (X-S) u 80 220
39、6 1/2 83 5 Small (S) 80 10 220 7 89 5 230 7 1/2 95 5 Medium (M) 95 10 230 8 102 6 230 8 1/2 109 6 Large (L) 110 10 230 9 and above W 110 Extra large (X-L) W 110 230 Smooth area: 0,08 Textured area: 0,11 Smooth area: 2,00 Textured area: 2,03ISO 11193-1:2008(E) ISO 2008 All rights reserved 5 Dimension
40、s in millimetres NOTE The distance 48 mm 9 mm locates the approximate centre of the palm for different glove sizes. Figure 2 Measurement points for the thickness of the glove 6.2 Watertightness When gloves are tested for watertightness as described in Annex A, the sample size and allowable number of
41、 non-conforming (leaking) gloves in the sample shall be determined in accordance with the inspection level and AQL given in Table 1. 6.3 Tensile properties 6.3.1 General Tensile properties shall be measured in accordance with ISO 37, taking three type 2 dumb-bell test pieces from each glove and usin
42、g the median value as the test result. Test pieces shall be taken from the palm or back of the gloves. ISO 11193-1:2008(E) 6 ISO 2008 All rights reserved6.3.2 Force at break and elongation at break before accelerated ageing When determined in accordance with the method specified in ISO 37, using typ
43、e 2 dumb-bell test pieces, the force at break and elongation at break shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1. 6.3.3 Force at break and elongation at break after accelerated ageing Accelerated ageing shall be conducted in accordance wi
44、th 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 and cutting the test pieces from the aged gloves, or by cutting the test pieces from unaged gloves and ageing the test pieces at 70 C 2 C for 168 h 2 h. Tensile testing is then condu
45、cted as described in 6.3.2. The results shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1. Table 3 Tensile properties Requirement Property Type 1 glove Type 2 glove Minimum force at break before accelerated ageing, N 7,0 7,0 Minimum elongation a
46、t break before accelerated ageing, % 650 500 Minimum force at break after accelerated ageing, N 6,0 7,0 Minimum elongation at break after accelerated ageing, % 500 400 6.4 Sterility If gloves are sterilized, the nature of the sterilization process shall be disclosed on request. 7 Packaging If gloves
47、 are sterilized, they shall be packaged individually or in pairs packed in unit packs. 8 Marking 8.1 General The marking shall include a reference to this part of ISO 11193. Appropriate international symbols taken from ISO 15223 may be used for labelling in addition to the wording given below. The l
48、anguage used for marking shall be as agreed upon between the interested parties. 8.2 Unit package 8.2.1 Sterile package The wrapping for each unit package of an individual glove or pair of gloves shall be clearly marked with the following: a) the name or trademark of the manufacturer or supplier; b)
49、 the material used; ISO 11193-1:2008(E) ISO 2008 All rights reserved 7 c) the words “TEXTURED” or “SMOOTH”, “PRE-POWDERED” or “POWDER-FREE” or words to that effect for the appropriate glove finish; d) the size; e) in the case of gloves that have been treated with any surface-dusting material, a warning note to the effect that surface powder should be aseptically removed prior to use; f) the manufacturers identifying lot number; g) the words “DATE OF MANUFACTURE” or words to
