ISO 11193-2-2006 Single-use medical examination gloves - Part 2 Specification for gloves made from poly(vinyl chloride)《一次性医用检查手套 第2部分 聚乙烯(氯乙烯)制成的手套规范》.pdf

1、 Reference number ISO 11193-2:2006(E) ISO 2006INTERNATIONAL STANDARD ISO 11193-2 First edition 2006-11-01 Single-use medical examination gloves Part 2: Specification for gloves made from poly(vinyl chloride) Gants en caoutchouc pour examen mdical, non rutilisables Partie 2: Spcifications pour gants

2、fabriqus en chlorure de polyvinyle ISO 11193-2:2006(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 are licensed to and installed on the comp

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5、 Central Secretariat at the address given below. ISO 2006 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

6、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 Switzerland ii ISO 2006 All rights reservedISO 11193-2:2006(E) ISO 20

7、06 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 2 6 Requirements 3 7 Packaging 4 8 Marking 4 Annex A (normative) Test for watertightness . 8 ISO 11193-2:2006(E) iv ISO 2006 All right

8、s 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 ISO technical committees. Each member body interested in a subject for

9、 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 closely with the International Electrotechnical Commission (IEC) on a

10、ll 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. Draft International Standards adopted by the technical committees are

11、 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 document may be the subject of patent rights. ISO shall not be held re

12、sponsible for identifying any or all such patent rights. ISO 11193-2 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses). This part of ISO 11193, together with ISO 11193-2, cancels and replaces ISO 11193:1994, which has been techn

13、ically revised. ISO 11193 consists of the following parts, 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 11193-2:2006

14、(E) ISO 2006 All rights reserved 1 Single-use medical examination gloves Part 2: Specification for gloves made from poly(vinyl chloride) WARNING Persons using this International Standard should be familiar with normal laboratory practices. This standard does not purport to address all of the safety

15、problems, if any, associated with its use. 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, poly(vinyl

16、chloride) gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. This part of ISO 11193 is intende

17、d as a reference for the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this part of ISO 11193. 2 Normative references

18、The following referenced documents 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 37:2005, Rubber, vulcanized or thermoplastic

19、Determination of tensile stress-strain 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 10

20、993 (all parts), Biological evaluation 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 11193-2:2006(E) 2

21、 ISO 2006 All rights reserved3 Classification Gloves are classified by finish as follows: a) textured surface over part or all of the glove; b) smooth surface; c) powdered surface; d) powder-free surface. NOTE 1 Powdered gloves are gloves where a powder has been added as a part of the manufacturing

22、process, generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate addition of powdered materials to facilitate donning. NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim. 4 Materials Gloves shall be manufactur

23、ed from plasticized poly(vinyl chloride). To facilitate donning the gloves, any surface treatment, lubricant, powder or polymer coating may be used. Any pigment, surface treatment, lubricant, or powder used shall be non-toxic and shall be disclosed on request. It is essential that substances used fo

24、r surface treatment, which 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, on request, data to support compliance with these requirements. NOTE Limits of extractable plast

25、icizers, residual chemicals 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. 5 Sampling and selection of test pieces 5.1 Sampling For reference purposes, gloves shall be sampled and inspect

26、ed 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 assumed. Table 1 Inspection levels and AQLs Characteristi

27、c Inspection level AQL Physical dimensions (width, length, thickness) S-2 4,0 Watertightness G-1 2,5 Force and elongation at break S-2 4,0 5.2 Selection of test pieces Where test pieces are required, they shall be taken from the palm or back of gloves. ISO 11193-2:2006(E) ISO 2006 All rights reserve

28、d 3 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 the shortest distance between the tip of the se

29、cond finger and the cuff termination. NOTE 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 thumb. The width measurement shall be made w

30、ith 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: a point of 13 mm 3 mm from the extreme tip of the second finger and the

31、 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 inspection indicates the presence of thin spots,

32、 the measurements shall be made in that area using a single-wall thickness. The thickness at the smooth area and textured area of a single-wall when measured as described in this subclause, using a test piece cut from the glove, shall be not less than 0,08 mm and 0,11 mm, respectively. NOTE The thic

33、kness of the cuff termination measured in accordance with ISO 23529 should preferably not exceed 2,50 mm. Table 2 Dimensions and tolerances Size code Width (dimensions w, Figure 1) mm Width (small, medium or large) Width by descriptive size (dimensions w, Figure 1) mm Minimum length (dimension l, Fi

34、gure 1) mm Minimum thickness (at the locations shown in Figure 2) mm Maximum thickness (at the approximate centre of the palm) mm 6 and below u 82 Extra small (X-S) u 80 220 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 a

35、bove W 110 Extra large (X-L) W 110 230 Smooth area: 0,08 Textured area: 0,11 Smooth area: 0,22 Textured area: 0,23 6.2 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

36、 determined in accordance with the inspection level and AQL given in Table 1. ISO 11193-2:2006(E) 4 ISO 2006 All rights reserved6.3 Tensile properties 6.3.1 General Tensile properties shall be measured in accordance with ISO 37, taking three pieces from each glove and using the median value as the t

37、est result. Test pieces shall be taken from the palm or back of gloves. 6.3.2 Force at break and elongation at break before accelerated ageing 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 compl

38、y 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 tests shall be conducted in accordance with the method specified in ISO 188. Test samples can either be prepared by

39、ageing the gloves at 70 C 2 C for 168 h 2 h and then cut from the aged gloves, or tensile samples can be cut from the gloves and then aged at 70 C 2 C for 168 h 2 h. Tensile tests are then conducted as described in 6.3.2. Table 3 Tensile properties Property Requirement Minimum force at break before

40、accelerated ageing, N 7,0 Minimum elongation at break before accelerated ageing, % 350 Minimum force at break after accelerated ageing, N 7,0 Minimum elongation at break after accelerated ageing, % 350 6.4 Sterility If gloves have been sterilized, the nature of the sterilization process shall be dis

41、closed on request. 7 Packaging If gloves are sterilized, they shall be packed individually or in pairs. 8 Marking 8.1 General Marking shall include a reference to this part of ISO 11193. Appropriate international symbols taken from ISO 15223 may be used for labelling. The language used for marking s

42、hall be as agreed upon between the interested parties. ISO 11193-2:2006(E) ISO 2006 All rights reserved 5 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 man

43、ufacturer 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; e) in the case of gloves that have been treated with any surface-dusting material, a warning note to the effect th

44、at surface powder should be aseptically removed prior to use; f) the manufacturers identifying lot number; g) the words “DATE OF MANUFACTURE“ or words to that effect, and the year in four digits and month of manufacture; h) the words “STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED“; i) the words “

45、FOR SINGLE USE“ or words to that effect; j) the words “EXAMINATION GLOVE“ (or “EXAMINATION GLOVES”) or “EXAM GLOVE“ (or “EXAM GLOVES”); k) the words “Product contains plasticizers (the nature of the plasticizers shall be disclosed) that may be harmful to users“. 8.2.2 Non-sterile package The package

46、 shall be clearly marked with the following: a) the name of trademark of the manufacturer 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; e) the manufacturers identifying l

47、ot number; f) the words “FOR SINGLE USE“ or words to that effect; g) the words “NON-STERILE“; h) the words “EXAMINATION GLOVE“ (or “EXAMINATION GLOVES”) or “EXAM GLOVE“ (or “EXAM GLOVES”); i) the words “DATE OF MANUFACTURE“ or words to that effect, and year in four digits and month of manufacture; j

48、) the words “Product contains plasticizers (the nature of the plasticizers shall be disclosed) that may be harmful to users“. ISO 11193-2:2006(E) 6 ISO 2006 All rights reserved8.3 Multi-unit package A multi-unit package is one containing a predetermined number of gloves (in unit packs or unpackaged)

49、 of the same glove size, intended to facilitate safe transport and storage. Multi-unit packages shall be marked in accordance with 8.2.1 or 8.2.2, with the approximate number of gloves and with the addition of instructions for storage. Key l length w width Figure 1 Measurement points for width and length ISO 11193-2:2006(E) ISO 2006 All rights reserved 7 Dimensions in millimetres NOTE The distance 48 mm 9 mm locates the approximate centre of the palm for different glove sizes.