ISO 10282-2014 Single-use sterile rubber surgical gloves - Specification《一次性无菌外科橡胶手套 规范》.pdf

《ISO 10282-2014 Single-use sterile rubber surgical gloves - Specification《一次性无菌外科橡胶手套 规范》.pdf》由会员分享，可在线阅读，更多相关《ISO 10282-2014 Single-use sterile rubber surgical gloves - Specification《一次性无菌外科橡胶手套 规范》.pdf（16页珍藏版）》请在麦多课文档分享上搜索。

1、 ISO 2014 Single-use sterile rubber surgical gloves Specification Gants en caoutchouc usage chirurgical, striles, non rutilisables S pcific ations INTERNATIONAL STANDARD ISO 10282 Third edition 2014-02-01 Reference number ISO 10282:2014(E) ISO 10282:2014(E)ii ISO 2014 All rights reserved COPYRIGHT P

2、ROTECTED DOCUMENT ISO 2014 All 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 an intranet, without prior written permission.

3、Permission can be requested 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 Switzerland ISO 10282:2014(E)

4、 ISO 2014 All rights reserved iii Contents Page Foreword iv 1 Scope . 1 2 Normative references 1 3 Classification 1 3.1 General . 1 3.2 Type 1 3.3 Design . 2 3.4 Finish . 2 4 Materials . 2 5 Sampling and selection of test pieces . 2 5.1 Sampling . 2 5.2 Selection of test pieces . 3 6 Requirements 3

5、6.1 Dimensions . 3 6.2 Watertightness 6 6.3 Tensile properties . 6 6.4 Sterility 7 7 Packaging . 7 8 Marking 7 8.1 General . 7 8.2 Inner package . 8 8.3 Unit package 8 8.4 Multi-unit package . 8 Annex A (normative) Test for watertightness . 9 ISO 10282:2014(E) Foreword ISO (the International Organiz

6、ation 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 technical committee has been established

7、 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 matters of electrotechnical standardization. T

8、he 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 approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the

9、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 the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent

10、 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). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For a

11、n 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 the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for th

12、is document is ISO/TC 45, Rubber and rubber products, Subcommittee SC 4, Products (other than hoses). This third edition cancels and replaces the second edition (ISO 10282:2002), of which it constitutes a minor revision. It also incorporates the Technical Corrigendum ISO 10282:2002/Cor.1:2005 and th

13、e following changes: addition of isoprene rubber latex as material for type 2 glove; only two finishes remain for classification, whereby powdered or powder-free finishes were deleted and introduced in the note; addition on the applicability of the warning note to the unit package on the removal of

14、surface- dusting material prior to undertaking operative procedures.iv ISO 2014 All rights reserved INTERNATIONAL ST ANDARD ISO 10282:2014(E) Single-use sterile rubber surgical gloves Specification 1 Scope This International Standard specifies requirements for packaged sterile rubber gloves intended

15、 for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces ove

16、r part or the whole glove. This International Standard is intended as a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging, and storage procedures are outside the scope of t

17、his International Standard. 2 Normative references The 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 d

18、ocument (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 resistance tests ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sam

19、pling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 10993 (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 fo

20、r preparing and conditioning test pieces for physical test methods 3 Classification 3.1 General Gloves are classified by type, design, and finish, as given in 3.2 to 3.4. 3.2 Type Two types are classified: a) Type 1: gloves made primarily from natural rubber latex. b) Type 2: gloves made primarily f

21、rom nitrile rubber latex, isoprene rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution. ISO 2014 All rights reserved 1 ISO 10282:2014(E) 3.3 Design Two designs are classified: a) gloves with straight fin

22、gers; b) gloves with fingers curved in the palmar direction. The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of the index finger rather than lying flat. The fingers and thumb can be straight or curved in the palmar direction. 3.4 Finish Two finishes are

23、classified: a) textured surface over part or all of the glove; b) smooth surface. NOTE 1 Gloves can be powdered or powder-free. Powdered gloves are gloves where a powder has been added as a part of the manufacturing process, generally to facilitate donning. Powder-free gloves are gloves which have b

24、een manufactured without the deliberate addition of powdered materials to facilitate donning. Powder-free is also referred to as “powderless”, “no powder” or “non-powdered” or other 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

25、Gloves shall be manufactured from compounded natural rubber or nitrile rubber or isoprene rubber or polychloroprene rubber latex, or compounded styrene-butadiene rubber or thermoplastic elastomer solution, or compounded styrene-butadiene rubber emulsion. To facilitate donning the gloves, any surface

26、 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 are capable of being transferred are bio-absorbable. Gloves as supplied to the user shall comply wi

27、th 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 may be included in future editions of this International Standard. NOTE 2 It is recognized that some

28、 individuals can, 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, residual chemicals, endotoxins, and residual powder in gloves may be specified

29、in future editions of this International Standard, 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 inspected in accordance with ISO 2859-1. The inspection levels and acceptance

30、 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.2 ISO 2014 All rights reserved ISO 10282:2014(E) Table 1 Inspection levels and AQLs Characteristic Inspection leveI AQL

31、 Physical dimensions (width, length, thickness) S-2 4,0 Watertightness G-I 1,5 Force at break and elongation at break (before and after accel- erated ageing) and force at 300 % elongation (before acceler- ated ageing) S-2 4,0 5.2 Selection of test pieces Where test pieces are required, they shall be

32、 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 the shortes

33、t distance between the tip of the second 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. T

34、he 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: a point 13 mm 3 mm from the extreme

35、tip of the second finger, the approximate centre of the palm, and a point 25 mm 5 mm from the cuff termination. 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 A

36、QL given in Table 1. If visual inspection 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 0,10 mm and 0,1

37、3 mm respectively. The thickness of the cuff termination measured in accordance with ISO 23529 should preferably not exceed 2,50 mm. ISO 2014 All rights reserved 3 ISO 10282:2014(E) Figure 1 Measurement points for width and length4 ISO 2014 All rights reserved ISO 10282:2014(E) Table 2 Dimensions an

38、d tolerances Size code Width (dimension w, Figure 1) mm Minimum length (dimension l, Figure 1) mm Minimum thickness (at the locations shown in Figure 2) mm 5 67 4 250For all sizes:Smooth area: 0,10Textured area: 0,13 5,5 72 4 250 6 77 5 260 6,5 83 5 260 7 89 5 270 7, 5 95 5 270 8 102 6 270 8,5 108 6

39、 280 9 114 6 280 9,5 121 6 280 ISO 2014 All rights reserved 5 ISO 10282:2014(E) Dimensions 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 thickness 6.2 Watertightness When gloves are tested for waterti

40、ghtness as described in Annex A, the sample size and allowable number of 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 IS

41、O 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 gloves.6 ISO 2014 All rights reserved ISO 10282:2014(E) 6.3.2 Force at break and elongation at break before accelerated ageing When deter

42、mined in accordance with the method specified in ISO 37, using type 2 dumb-bell test pieces, the force at break, force at 300 % elongation and elongation at break shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1. Table 3 Tensile properties Prop

43、erty Requirement Type 1 glove Type 2 glove Minimum force at break before accelerated ageing, N 12,5 9,0 Minimum elongation at break before accelerated ageing, % 700 600 Maximum force required to produce 300 % elongation before accelerated age- ing, N 2,0 3,0 Minimum force at break after accelerated

44、ageing, N 9,5 9,0 Minimum elongation at break after accelerated ageing, % 550 500 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. After the test pieces cut from the gloves have been

45、subjected to a temperature of 70 C 2 C for 168 h 2 h, the value of the force at break and the elongation at break shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1. 6.3.4 Force required to produce 300 % elongation When determined in accordance w

46、ith the method specified in ISO 37, using type 2 dumb-bell test pieces, the force required to produce an elongation of 300 % shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1. 6.4 Sterility Gloves shall be sterilized. The nature of the steriliza

47、tion process shall be disclosed on request. 7 Packaging Gloves shall be packaged in sequential two-layered packaging. 8 Marking 8.1 General 8.1.1 The marking shall include a reference to this International Standard. Appropriate international symbols taken from ISO 15223 can be used for labelling. 8.

48、1.2 The language used for marking shall be as agreed upon between the interested parties. 8.1.3 In the case of gloves that have been treated with any surface-dusting material, a warning note shall be clearly marked on the inner package and/or unit package; to the effect that surface powder should be

49、 aseptically removed prior to undertaking operative procedures. ISO 2014 All rights reserved 7 ISO 10282:2014(E) 8.2 Inner package Inner packages shall be clearly marked with the following: a) the size; b) the designation “left” or “L” or “right” or “R” on the package. 8.3 Unit package The outer wrapping for each unit pair of gloves shall be clearly marked with the following: a) the name or trademark of the manufacturer or supplier; b) the material used; c) the words “STRAIGHT FIN