YLOZI6LLY SZNISY ‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 05 Aug 2014 (Document currency not quaranteed when printed) ASINZS 4179:2014 © Australian/New Zealand fantiard™ Single-use sterile r i r surgical gloves—Specifi‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2074 (Document currency not guaranteed when printed) AS/NZS 4179:2014 This Joint Australian/New Zealand Standard was prepared by Jomt Technical Committee HE-013, Surgical Apparel. It was approved on behalf of the Council of Standards Australia on 2 July 2014 and on behalf of the Council of Standards New Zealand on 3 July 2014. This Standard was published on 21 July 2014, = oo The following are represented on Committee HE-013: 5 Australian Chamber of Commerce and Industry KS Australian College of Operating Room Nurses ae Australian Dental Association ‘ Australian Nursing and Midwifery Federation 2 Department of Health, Vie. é, Medical Technology Association of Australia & New Zealand Nurses Organisation & NSW Ministry of Health se Product Evaluation Health, New Zealand as Queensland Health a Royal College of Pathologists of Australasia © Testing Inerests (Australia) ad Therapeutic Goods Administration a } Se Standards up-to-date Standards are livi its which reflect progress in science, technology and systems, To mai currency, all Standards are periodically reviewed, and new editions arc ied. Between editions, amendments may be issued, Standards may. also Be withdrawn. It is important that readers assure themselves they are sig i cuent Standard, which should include any amendments which n pul may have fished since the Standard was purchased. Detailed in}yfination about joint Australian/New Zealand Standards can be found by visit fandards Web Shop at www.saiglobal.com.au or Standards New Zeal site at www.standards.co.nz and looking up the relevant Standard in thé*Bp- lite Catalogue, frequent listings or notification of revisions, amendments and awals, Standards Australia and Standards New Zealand offer a number of options. For information about these services, users should contact their pective national Standards organization, fe also welcome suggestions for improvement in our Standards, and especially ‘encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive of either Standards Australia or Standards New Zealand at the address shown on the back cover. This Standard was issued in draft form for comment as DR ASINZS 4179.‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 204 (Document currency not guorantzed when printed) * > ASINZS 4179:2014 € ge 2 estas Fr era ear we 2014 ~ eye & copyRiGhT © Standards Australia Limited/Standarde New Zealand All rights are reserved. No part ofthis work may be reproduced or copied In any form or by any means, electronic or mechanical, including photocopying, without the written, Permission of the publisher, unless otherwise permilted under the Copyright Act 1968 (Australia) or the Copyright Act 1994 (New Zealand), Jointly published by SAI Global Limited under licence from Standards Australia Limited, GPO Box 476, Sydney, NSW 2001 and by Standards New Zealand, Private Gag 2439, Wellington 6140, ISBN 978 1 74342 6009‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) ASINZS 4179:2014 fi PREFACE This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HE-013, Surgical Apparel, to supersede AS/NZS 4179:1997, Single-use sterile surgical rubber gloves—Specification. This Standard is an adoption with national modifications and has been reproyced from 180 10282:2014, Single-use sterile rubber surgical gloves—Specification. The variations to ISO 10282, which are necessary for Australian/New Zealand cor (Os, ‘ire listed in Appendices ZZ and ZA, following the source text. : The objective of this revision is to adopt the ISO Standard with Australian‘New*gealand technical variations to the following Clauses of ISO 10282: (a) Clause 2, Normative references. (b) Clause 3.2, Type. (©) Clause 4, Materials. (@ Clause 5.1, Sampling. (©) Clause 5.2, Selection of test pieces. (1) Clause 6.3, Tensile properties. (g) Clause 6.4, Sterility. (h) Clause 8.3, Unit package. (Annex A, Clause A.2, Procedure. = As this Standard is reproduced from an inde Standard, the following applies: (In the source text ‘this taal eodae should read ‘this Australian/New Zealand Standard’, Gi) A full point substitutes for ma When referring to a decimal marker. References to Internation ds should be replaced by references to Australian or Australian/New Zealand Standixds¥as follows: Reference to Internatiqnal Staytard Australian/New Zealand Standard Iso AS 2859 © Sampli jures for inspection by 1199 Sampling procedures for inspection by attri attributes 2859-1 Pagf | ling schemes indexed by 1199.1. Part 1: Sampling schemes indexed by ince quality limit (AQL) for lot- acceptable quality limit (AQL) for lot- poe inspection by-lot inspection 7 ASINZS ISO 11137 Sterilization of health care products— 11137 _ Sterilization of health care products— (all parts) Radiation (all parts) Radiation Only international references that have been adopted as Australian or Australian/New Zealand Standard have been listed. The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of the annex or appendix to which they apply. A ‘normative’ annex or appendix is an integral part of a Standard, whereas an ‘informative’ annex or appendix is only for information and guidance.‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document curtency not guaranteed when printed) ASINZS 4179:2014 itt CONTENTS a) pace = 2 Normative references. 3 Classification : 34 General 32 Type... i f 7 33° Design... meee 34 Finish z 4 Materials. 5 Sampling and selection of test pieces. 5.1 Sampling. none pct 5.2 Selection of test pieces. — 6 Requirements. 61 Dimensions...... 6.2 Watertightness. 63 — Tensile properties. Sc 7 Packaging...... Ce 81 General. sasasneeeesne 82 Inner package. 83 — Unit package. 7 84 — Multi-unit package 7 seal Annex A (normative) Test for men ge @ ws < < SASINZS 4179:2014 {paiuid uoym poowuesend you Kousund weumncog) paz Bay go UO VISAVIYW SOMVONVS 40 INSWLM¥dd - L3NOS! Aa passanoy‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on G6 Aug 2014 (Document curency not guaranteed when printed) ASINZS 4179:2014 4 AUSTRALIAN/NEW ZEALAND STANDARD. Single-use sterile rubber surgical gloves—Specification (ISO 10282:2014, MOD) 1 Scope ‘This International Standard specifies requirements for packaged sterile rubber glovs in surgical procedures to protect the patient and the user from cross-contaminati of 1 single-use gloves that are worn once and then discarded. It does not apply to examiiation or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaceé ‘ovagpart or the whole glove. 7 % This International Standard is intended as a reference for the performancand Safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilizatign roeédures with subsequent handling, packaging, and storage procedures are outside the scope ofthié International Standard, 2 Normative references Ww ‘The following documents, in whole or in part, are ey in this document and are us indispensable for its application. For dated reference the edition cited applies. For undated references, the latest edition of the referenced a is ling any amendments) applies. 180 37, Rubber, vulcanized or thermoplastic — Determinition of tensile stress-strain properties 180 188, Rubber, vulcanized or thermoplastic oe ageing and heat resistance tests ISO 2859-1, Sampling procedures for inspé foheiy. attributes — Part 1: Sampling schemes indexed by acceptance quality limit (QL) for lt-by-locinspegtion ISO 10993 (all parts), Biological evalyasion@f medical devices 1SO 15223, Medical devices — Symbolgto be used with medical device labels, labelling and information to be supplied é 1S0 23529, Rubber — General pPageitlires for preparing and conditioning test pieces for physical test methods 3 os by type, design, and finish, as given in 3.2 to 3.4. ‘Two types are classified: a) Type 1: gloves made primarily from natural rubber latex, b) Type 2: gloves made primarily from nitrile rubber latex, isoprene rubber latex, polychloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution. COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not uerantsed when printed) ASINZS 4179:2014 2 3.3. Design ‘Two designs are classifi a) gloves with straight fingers, 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 a © * ‘Two finishes are classified: AQ a) textured surface over part or all of the glove; ) 1b) smooth surface. Yr NOTE1 — Gloves can be powdered or powder-free. Powdered gloves are gloves witefe a powder has been added asa part of the manufacturing process, generally to facilitate donning. Powdéhaérgé gloves are gloves which have been manufactured without the deliberate addition of powdered mate ilitate donning. Powder-free is also referred to as “powderless’, ‘no powder” or “non-powdered” or: isto that effect. NOTE2 The cuff termination ofthe glove may be cut orn the fa rolled rim, 4 Materials Gloves shall be manufactured from compounded gmbipiner or nitrile rubber or isoprene rubber or polychloroprene rubber latex, or compounded,Styrene-butadiene rubber or thermoplastic elastomer solution, or compounded styrene-butadiene rikjber emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or pi coating may be used subject to compliance with Is0 10993, Any pigment used shall be non-toxic. It capable of being transferred are bi Ly ial that substances used for surface treatment which are ble. Gloves as supplied to the user shi iply with the relevant part(s} of ISO 10993, The manufacturer shall make available to the me? m request, data to support compliance with these requirements, NOTE1 Other suitable polfageric Materials may be included in future editions ofthis International Standard. ‘ome individuals can, over a period of time, become sensitized to a particular NOTE2 _ Itis recognigé rubber compound (allegation) and require gloves ofan alternative formulation. NOTES Limits éfgxtra@table proteins, allergenicproteins, residual chemicals, endotoxins, and residual powder in gloves may be sae sd in future editions of this International Standard, subject to the availability of relevant Iso standard ods, 5 Sampling and selection of test pieces 5.1 Sampling For reference purposes, gloves shall be sampled and inspected in accordance with SO 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. COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA cn 06 Aug 2074 (Decument currency not guaranteed when printed) ASINZS 4179:2014 3 ‘Table 1 — Inspection levels and AQLS Characteristic Inspection level AQL Physical dimenstons (width, length, thickness) S2 40 Watertightness GI 45 Force at break and elongation at break (before and after accel- S2 40 Jerated ageing) and force at 300 % elongation (before acceler lated ageing) Se, 5.2 Selection of test pieces ce Where test pieces are required, they shall be taken from the palm or back o! dates! ee, ) 6 Requirements /. 4 6.1 Dimensions When measured at the points shown in Figure 1, gloves shalncon ly with the dimensions for palm width and length given in Table 2, using the inspection phy given in Table 1. The measurement of length shall be the shortest distay€@ Bef wéen the tip of the second finger and the cuff termination. Re pi fr teed NOTE The length measurement may be taken by hangingithe glove on a suitable mandrel with a tip radius of 5mm, ‘ ‘The measurement of width shall be at the ide between the base of the index finger and the base of the thumb. The width measurement shall,samade with the glove placed on a flat surface. ‘The thickness of the double wall of an intat€ love shall be measured in accordance with ISO 23529, with a pressure on the foot of 22 kPa+5 KI of the locations shown in Figure 2: a point 13 mm 3mm from the extreme tip of the secon, ; the approximate centre ofthe palm, and a point 25 mm + 5 mm from the cufftermination. The I thickness at each point shall be reported as half the measured double-wall thickness and s ly with the dimensions given in Table 2, using the inspection level and AQL given in Table 1. If visual inspection indicatts,the presence of thin spots, then single-wall thickness measurements shall be made in such aeegesthe thickness at the smooth area and textured area of a single wall when measured as described in tis subclause shall not be less than 0,10 mm and 0,13 mm respectively. The thickness ct termination measured in accordance with ISO 23529 should preferably not exceed 2,50 Zin & COPYRIGHTASINZS 4179:2014 4 ‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2044 (Document currency not guaranteed when printed) ‘COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA cn 06 Aug 2014 {Document curency not guaranteed when printed) ASINZS 4179:2014 Table 2 — Dimensions and tolerances COPYRIGHT Width Minimum length Minimum thickness ape Gimension w, (dimension , {atthe locations shown Figure 1) Figure 1) ‘in Figure 2) mm ‘mm mm 5 744 250 55 s4 250 6 1755 260 ee 6: a3 60 % . 29 3 7 fe « : i i oS rea: 0,10 75. 9545 270 Nene area: 0; a 10256 270 pager 85 10826 280 t UY 9 11426 230 fy 95 12146 200 Ny £‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document curency not guaranteed when printed) ASINZS 4179:2014 6 Dimensions in millimetres NOTE The distance 48 mm £9 mmplocates the approximate centre of the palm for different glove sizes. Baure 2.— Measurement points for thickness % 6.2 a When glove fed for watertightness as described in Annex A, the sample size and allowable number of ton€dnforming (leaking) gloves in the sample shall be determined in accordance with the inspection levelénd 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 using the median value as the test result. Test pieces shall be taken from the palm or back of gloves. COPYRIGHT‘Accassed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 08 Aug 2014 (Oocument currency not guaranteed when printed) ASINZS 4179:2014 7 6.3.2 Force at break and elongation at break before accelerated ageing When determined in accordance with the method specified in IS0 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 ms Reqilicement ‘Type 1 ploge | Type 2 glove Minimum force at break before accelerated ageing, N fs 9,0 Minimum efongation at break before accelerated ageing, % 600 Maximum force required to produce 300 % elongation before accelerated age- J 3 i ing, N ea| te : ‘Minimum force at break after accelerated ageing, N & iB 95 9.0 [Minimum elongation at break after accelerated ageing, % é 550, 500 6.3.3 Force at break and elongation at break after accelefatgd ageing Accelerated ageing tests shall be conducted in accordansae method specified in ISO 188, After the test pieces cut from the gloves have been subjected'to a teniperature of 70 °C + 2 °C for 168h + 2h, the value of the force at break and the elongation at bréak shiall comply with the requirements given in ‘Table 3, using the inspection level and AQL given i at 6.3.4 Force required to produce 300% al When determined in accordance with thestfethod Specified in ISO 37, using type 2 dumb-bell test pieces, the force required to produce an snd ‘of 300 % shall comply with the requirements given in i QI Table 3, the inspection level an jiven in Table 1. 6.4 Sterility Gloves shall be sterilized. T| of the sterilization process shall be disclosed on request. 7 Packaging we Gloves shall be pacKaged int sequential two-layered packaging. gs 81 genet : ex rtn shall include a reference to this International Standard, Appropriate international symbols taken from ISO 15223 can be used for labelling, 8 Mart 8.1.2 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 aseptically removed prior to undertaking operative procedures, ‘COPYRIGHT‘Accessed’ by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2074 (Decument currency nat guaranteed when printed) ASINZS 4179:2014 8 8.2 Inner package Inner packages shall be clearly marked with the following: a) thesize; 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 aey a) the name or trademark of the manufacturer or supplier; b) the material used; A “SS % ©) the words “STRAIGHT FINGERS” or "CURVED FINGERS" or words to thatgffect for the appropriate glove design; 2 ) the words “TEXTURED” or “SMOOTH”, “PRE-POWDERED" or -rovhghs EE” or words to that effect for the appropriate glove finish; SS ©) the size; & we a f) the manufacturer's identifying lot number; 5 Thy £ g) the words “DATE OF MANUFACTURE” or words to thaf‘elfectZind the year in four digits and month of manufacture; h) the words “STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED"; i) the words “FOR SINGLE USE”; j) the words “SURGICAL GLOVES"; to that effect for type 1 gloves. 8.4 Multi-unit package Q ii A multi-umit package is one cgnt: ‘a predetermined number of unit packs of the same glove size, intended to facilitate safe antag and storage. Multi-unit packages shall be marked in accordance with 83 3), 880), B80, Bid) 6), 8.3), B.3 g), 8.31) and B.3§), with the words “xx pairs of surgical gloves” and with the A instructions for storage. fs & 1) the words “Product is made from eS ibber latex which can cause allergic reactions” or words COPYRIGHT‘Accossed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Dooument cumency not queranted when printed) ASINZS 4179:2014 9 Annex A (normative) Test for watertightness Al Apparatus oS AL Circular hollow mandrel, of minimum external diameter 60 mm an eats é length to hold the ipleis given in Figure AL. glove and, with the glove attached, to accommodate 1 000 cm3 of water, An, NOTE Icisuseful the mandrel is transparent, © A.1.2 Holding device, designed to hold the glove in vertical posi n filled with water. An example is given in Figure A. AL3 Graduated cylinder, capacity at least 1 000 cmSegr offer dispensing apparatus capable of delivering 1 000 em’ at a time. a re at A2 Procedure gh tae! Attach the glove to the circular hollow mandrelipy a suitable device, e.g. an O-ring, so that the glove does not extend more than 40 mm over the mandrel, Introduce 1000 cm? + 50 cm3 of water af imum temperature of 36 °C into the device. Remove any water that has inadvertently splashed on't,the glove. If the water does not rise to within 40 mm of the cuff end, raise the glove to ensure thf Yrewhole of the glove, excluding the part 40 mm from the cuff end, is tested. Note any leaks immedjatly evident. Ifthe glove does not leak immediately, make a second observation for leaks 2 min to er pouring the water into the glove. Disregard leakage within 40 mm of the cuff end. To OS srvation, the water can be coloured with a water-soluble dye. COPYRIGHT10 ASINZS 4179:2014 Dimensions in millimetres Figure A.1 — Mandel “ cylinder 3 score line on inside surface of wall hook Key 1 2 {(Bewuud uety pecuesen6 you fououuno wousnc0q) voz SY 90 UO VISAVIVNY SCEYONVAS 40 INEVLLYEa - 13NOSI/q passeocy COPYRIGHTASINZS 4179:2014 zu é WY Figure A.2 o ) ice a _ (Poyusd vay paowueren6 jou Kouauno wuownoeg) #i¢e Bn 80 Wo VISAVIYW SCEVGNY: —) s eS {1S JO ANALLAVEBO - 13NOSI Aa passscoy COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 08 Aug 2014 (Document currency not guaranteed whan printed) ASINZS 4178: 12 APPENDIX ZZ VARIATIONS TO ISO 10282:2014 FOR AUSTRALIA AND NEW ZEALAND (Normative) ZA SCOPE This Appendix lists the normative variations to ISO 10282:2014 for applications in Australia and New Zealand. ZZ2_ VARIATIONS cr x The following modifications are required for Australian/New Zealand conditions: ) Clause 2 1 Add after ISO 2859-1 the following: ~~ ISO 5893, Rubber and plastics test So sfoongton flexural and ecfi compression types (constant rate of traverse)—S| ton. 2 Add a Note below ISO 10993 (all parts), Bio, Set tet of medical devices -, NOTE Users of this Standard are directe’ it 1 of ISO 10993, in the first instance, to assess which other parts of thig seriesare relevant. 3. Add after 180 10993 (all pans) mefotiawie: 1SO 11136 (all parts), Sterilization bthéalth care products—Ethylene oxide. 180 11137 (all parts), Sterilization gf health care products—Radiation. Clause 3.2 Delete the existing text and replice with the following Clause: Glove types are classified g@ifolloW: (@) Type 1: gloves, wean from natural rubber latex. (b) Type 1a: synthetie,plyisoprene. (©) Type 2: Grin primarily from nitrile rubber latex, polychloroprene rubber JatexSegtyrene-butadiene rubber solution, styrene-butadiene rubber emul pore elastometer solution. wre \etic polyisoprene (synthetic rubber latex) has been classified as type 1a, its material properties are more closely related to natural rubber latex than at of Glove materials listed under type 2. Clause 4 ¥ rt the following before the first paragraph: #% 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. In the first paragraph, insert ‘or synthetic polyisoprene’ following, ‘compounded styrene-butadiene rubber’. 3 Delete second and third paragraphs. 4 Delete the words ‘extractable proteins,” in Note 3. 5 Insert the following additional note after Note 3: NOTE 4 For test methods for extractable proteins from natural rubber latex gloves, see ISO 12243, Medical gloves made from natural rubber latex—Determination of water-extractable protein using the modified Lowry method. Maximum level of 50 ugidm® is recommended for powder-free gloves and 200 pg/dm* for powdered gloves. COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document curency not quaranteed when printed) ASINZS 4179:2014 13 Clause 5.1 Replace the first sentence with the following: For reference purposes, finished, sterile gloves as presented to the end user, shall be sampled and inspected in accordance with ISO 2859-1. Table 1 For watertightness, replace existing AQL value of 1.5 with 1.0 Clause 5.2 Delete the existing text and replace with the follow See Clause 6.3.1 eee and Delete the existing clause and Table 3 and replace with the following S 6.3 Tensile properties O 6.3.1 General 180 5893, Class 1.0 or better. The speed of theftestipg machine shall be 500 mm/min + 10 mm/min. Dumb-bell test pieces shail Be.cuf using a Type 2 dumb- bell cutter as specified in ISO 37, taking three t ss from each glove and using the median value as the test result for eacl ipdvial glove tested. Test pieces shall be taken from the palm or back oftng fished, sterile gloves, with the long axis parallel to the fingers, Ny i 6.3.2 Protection of samples and rn op ‘Samples and test pieces shall be pretectéthaS completely as possible from light and heat prior to testing. % 6.3.3 Conditioning of sample Condition all samples, at lard laboratory temperature, without humidity control, for not less than wise cutting out the test pieces. 6.3.4 Force at nee ingation at break before accelerated ageing Tensile properties shall be measured using a cae accordance with per When determined, dance with 6.3.1 to 6.3.3, the tensile properties shall be as specified in Ts NOTE The reujemshts of Clauses 6.3.1 to 6.3.4 are intended to mirror those of ISO 37, as far 9s is mich View of the type of test piece available. wy TABLE 3 & ‘TENSILE PROPERTIES Q> a a type ta glove | T9P** love SS ‘Minimum force at break before accelerated ageing, N 128 90 Minimum elongation at break before accelerated ageing, % 700 600. Maximum force required to produce 300% elongation, before accelerated ageing, N 2.0 oe ‘Minimum force at break after accelerated ageing, N 98 9.0 ‘Minimum force at break after accelerated ageing, % 530 500, COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) ASINZS 4179:2014 Clause 6.4 Clause 8.3 Clause A.2 14 6.3.5 Force at break and elongation at break after accelerated ageing Accelerated ageing tests shall be conducted in accordance the method specified in ISO 188. After the test pieces cut from the gloves have been subjected to a temperature of 70°C # 2°C for 168 h 42h, 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 4 6.3.6 Force required to produce 300% elongation When determined in accordance with the method specified in Clause: ayo 6.3.3, using type 2 dumb-bell test pieces, the force required to prota longation of 300% shall comply with the requirements given in Table wt 18 “inspection level and AQL given in Table 1 6.3.7 Glove cuff rupture resistance Glove cuff rupture testing is not mandatory, but mig AS when the cuff rupture resistance of a particular product is in dispute. tes method for glove cuff Tupture resistance is set out in Appendix ZA. TI quired to rupture the material of the cuff of the glove should not be x Delete the paragraph and replace wit Gloves shall be sterilized in accordance ae or ISO 11137. The nature of the sleiization process shall be disclosed 0} duct in accordance with appropriate local regulatory requirements. Add a Note after Item (k) ce NOTE This does not apply to typelYa gloves. Delete the last two sentences.of séeond paragraph and add the following: During this second obsefvatiofi® examine all the directly visible surfaces and also separate the fingers: by hand and examine the space between thom, ‘especially the crutch. are where the fingers join the palm. A folded paper moved up ey e"may be placed between each pair of adjacent fingers, and the joint between them to facilitate detection of leaks in this, )Dark spots on the paper indicate a leak might be present. region of nes Disregard leaRage within 40 mm of the cuff end of the glove. To assist observation, COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) ASINZS 4179:2014 18 APPENDIX ZA TEST METHOD FOR GLOVE CUFF RUPTURE RESISTANCE (informative) ZA1 SCOPE This Appendix provides the test method for determining the rupture resistance of the material Wf. the glove cuff [see Clause 6.3.7 (Appendix ZZ). - ZA2 TEST METHOD © ZA2A Principle ~ A section of the glove cuff material to be tested is held in place on a plate,eontaitfing a central hole. A stainless steel pin of specified dimensions, attached to a freely moving shaft{is cafefully positioned on the rubber surface immediately above the central hole. The pin is driven doy constant speed until it ruptures the glove material. ZA2.2 Apparatus ww ‘The following apparatus is required: % (8) Tensile testing machine, complying with 180 5893fclas%;1‘0 or better, and capable of a cross- head speed of 0 mm/min, gn a () Holding device, consisting of— t J () acylindrical stainless steel or rigid pldgtic base: and Gi) {al to the cylindrical base, approximately 10 mm. The ring is tapered outwar: the bottom with an included angle of 5°, and makes a tight fit on the cylindrical b: minor diameter. All active surfaces are polished to a smooth finish, (©) Stainless steel pin, attache \¢ tensile testing machine. Figure ZAI depicts the holdi and pin. ZA2.3 Procedure sina@coried out at ambient temperature, is as follows: wise. The procedure, which fa) () the test specimen site (see Figure ZA2) with the centre of the holding device aS ‘onto the cylindrical base, and tightly fit the clamping ring (see Figure ZA1). © Ut tensile testing machine, drive the stainless steel pin through the centre of the test pike af constant speed of 50 mm/min, until rupture of the test piece occurs. (@) Record the force when rupture of the test piece occurs, in newtons. ZA2A Report The following should be reported: (a) The material of the test piece. (b) The force required to rupture the test material, in newtons. (©) The type of glove tested (i.e. examination glove), (@) A reference to this test method (i.e. AS/NZS 4179, Appendix ZA). COPYRIGHT‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) ASINZS 4179:2014 16 4.0 20.1 | Stainiess stee! pin 80 min. Sample P15 20.2 rn IONS IN MILLIMETRES FIGURE ZA1 §, |OLDING DEVICE WITH STAINLESS STEEL PIN COPYRIGHTASINZS 4179:2014 © (Poyaud wow pooyuesen8 ou fouauine yuouuncog) r4.0¢ Bny 90 UO VISAVIVIN SCUVANV1S 40 NSWLA¥d30 ~ 13NOS! Ag pesss0oy COPYRIGHTASINZS 4179:2014 (Parad uaun paoquerens ou Foua.ina juounsog) $402 BrY G0 UO VISAVIVIN SCUVONYLS JO LNAMLEWESO * 13 INOSI Aa passecoyASINZS 4179:2014 (Pend usyn paequerens you foueuine wownoog) rho2 En 90 Uo ViSAVTYW SCUVONYLS JO LNSAILSVa ~ L3NOS! Ka pesseaayASINZS 4179:2014 (Parupd uotya poszuerené you Kouasin> wownseg) #102 Bry 80 UO WISAYIWW SCRVONVLS 40 LNWLLSWezO - L3NOS! Aq pass200y‘Accessed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 08 Aug 2014 (Document currency not guaranteed when printed) ~~ = © Standards Australia a. 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Through @ Memorandum of Understanding with tauorymonweatth government, Standards Australia is recognized as Australia's pealegationalStandards body. & Standards Now Zealand The first national Standards organization was created in Ni Council of New Zealand is the national authority respofisl Standards New Zealand is the trading arm of the Sta Zeris ‘Act 1988. 4 Zeljand in 1992, The Standarés the production of Standards. rds Council established under the Standards Australian/New Zealand Standards Under a Memorandum of Understanding betivgen Standards Australia and Standards New Zealand, Australian/New Zealand Standards are RypBafed by committees of experts from industry, governments, consumers and ot ‘The requirements of recommendations contained in published Standards are a con: ees of the views of representative interests and also take account of comments receis other sources. They reflect the latest scientific and industry experience. Australian/Net Standards are kept under continuous review after publication and are updated maeey @ account of changing technology. a ange Stunning NG Stanarte Now ana ar reeposhl fr ensuring ta the Aunts snd Hew Zepto are conser te fomaaton of iematonal tana ad tat the lates ge ona experience is incorporated in national and Joint Standards, This role is vital in assisting Toca industry to compete in international markets. Both organizations are the national meepete iSO (ne inemational Orgonizaion for Standardeaton and I (he international Electratetinical Commission). Visit our web sites www.standards.org.au www.standards.co.nz‘Accoseed by ISONET - DEPARTMENT OF STANDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) TARIKH DIKEMBALIKAN (DATE DUE) |_0. 8-SEP 20%4' S 5 ISBN 978 1 74342 600 9 (GPO Box 478 Sydney NSW 2001 tions (02) 9297 6000, Fax (02)8237 6010 mall mal@standaris.org 20, Interest wv standarde.org.u SAI Global Customer Service Phone 131242 Fex 1900 6549.49 Email salos@saiglobal com Levels {8 Gimer Terrace Wellgton 6011 (Pivate Bag 2439 Wetington 6140) Freephone 0800 762.632 Phone (04 498 S800 Fax (04408 5554 Email enauries@standards.co.nz Website wnw.standarde co.nz Printed in AustraliaDARDS MALAYSIA on 06 Aug 2014 (Document currency not guaranteed when printed) = ‘Accessed by ISONET - DEPARTMENT OF STAI = RY od This page has been left intogogany blank. Nd Cy Ret