"Winrar we dee in one th ian rie ri on sda ating heck a i fr he : SIRIM LIBRARY Designation: D5151 -19 sa AAO Standard Test Method for Detection of Holes in Medical Gloves’ This tnd sed unr the ed devgntonDSISI: the number mmcinly Sowing the desation ndctes the yer of latin oe he ene of ein, the eno lat revision. Aner in peste aes he ear fs rappel A 1, Seope LI This test method covers the detection of holes in medical gloves, 1.2 This test method is limited to the detection of holes that low water leakage under the conditions of the test 1.3. The smallest hole size that will allow water leakage in a ‘medical glove has not been determined and is beyond the scope ofthis test method. 1.4 ‘The safe and proper use of medical gloves is heyond the scope of this test method 1.5 The values stated in SI units are to be regarded as sandard. No other units of measurement are included in this standard 16 This standant does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro: priate safets, health, and environmental practices and deter: imine the applicability of regulatory limitations prior to ase. 17 This international standard was developed in accor: dance with internationally recognized principles on standard- ization established in the Decision on Principles. for the Development of Intemational Standards, Guides and Recon mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committe. 2. Terminology 2.1 Definitions of Terms Specific 10 This Standard: LL medical gloves, n—medical gloves. as used in this test ‘method, refer to both surgical and examination glove: 3. Significance and Use 3.1 This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove. 3.2 This test method is suitable and designed as a reference ‘method to evaluate samples of medical gloves. "Thistest mead snd the ron of ASTM Commince DI on Rubber ang Rare Mate ans he rest expo of Suomi DUAD on Commer aber Pr Comer eitonspprved Ox 1, 2019. Published October 2019, Origa peed in 199, Las presi eon arose in 2018 we DSISI-O6 1, DOL VarS2HDSi5i-1. 4. Apparatus 4.1 Mandrel—A clear plastic tube, nominally 6 > 0.5 em ‘outside diameter, 5 em inside diameter or 50 mm schedule 80 poly(vinyl chloride) (PVC) pipe, 38 * 1 em long. The mandrel shall have a clamp or rubber band for securing the glove to the mandrel 4.2 Graduated Cylinder or Beaker—As & minimum, the ‘graduated cylinder or beaker shall he marked in increments of 50 em* to a capacity of 1000 cm*. The markings shall be accurate to within +10 em? at volumes greater than 500 em’ 43 Stopwateh. 4A Various Clamps, Hangers, and Stands 5. Reagents 5.1 Tap Water—The water used in this test method shall be clean and free from any visible contaminants, 6, Procedure 6.1 Throughout 6.2 and 6.3, ensure that the exterior of the love remains dey. 6.2 Mount the mandrel in a vertical postion using appro- priate stands, clamps, and hangers. Affix the glove to the ‘mandrel by stetching the cuff of the glove around the mandrel ‘A maximum 40 mm of glove cuff should fit over the bottom tend of the mandrel, Use the securing device, as necessary, to hold the glove in place. The remainder of the glove should thang freely from the mandel when filled with water. 63 Pour 9 minimum of 1000 em of room temperature water (at 16, 20-16 30°C} nto the top of the mane. The ‘water shall pass freely into the glove. 64 Visually inspect the glove for immediate water eskage Let the glove hang for 2 min and agsin inspect for water leakage 7. Interpretation of Results 7.1 Any glove that shows a droplet, steam, or other type of ‘water leakage shall be considered to have failed the tes 7.2 Water leakage above the junction of the glove euff and mandrel is not atest filute If this leakage occurs, remove and dry the outside of the glove and retest sy"ANOASTH orate, 0 Her Dm, PO Box CTD Wes Crbotnctan, 962958, Ua SarAi] 05151 - 19 8. Report 10. Keywords 8.1 The report shall include the number of samples tested, 10.1 detection; gloves: holes: medical the numberof failures, and a general description ofthe location of each hole. 9. Precision sand Bias 9.1. No statement is made about either the precision or bias of this test method, This is a “pass-fail” test procedure not subject tothe usual analysis for quantitative variable precision ASTH iterator! aes no poston respecting the vay of ary pat ris assed conaecien h any dom mentored ‘nis tad Users o i tnd are expressly aie tat otras othe way any oh ato hs nd ak ‘tintingenent of sri, a7 ent onn reponat ‘The standards eutet to even at any tine by te response etnies commits and must bo evened every fe yeas and ‘not resed er reaperovadorwahdraun, Your Comment rented ear revo ofthe sanded oo ostna sercaas and shout be antessea fo ASTM PeraonalHoacouariers. Your comments ilocos casa eonitcn a Meso ‘eponstie tecnica conte, whic yeu may atone fel a your cameras have Nl ecewed fav heath ou shoud ‘make your ves known fo he ASTM Commie on Stara the astro shown bat Cc "This stan is copyeied by ASTI Itational, 100 Bar Harber Dive, PO Box C700, Was! Conshohocken, PA 19428-2858 nied Sats. nnd! ropes (angle er mute ops) of tis sandor may be obaned by Cotactng AGTH ate above actress or at 610.892.0685 (ore), 610-892-9566 (fn), or serio Basmnor (ena), o” twough the ASTA webete {awovesim og. Perison rhs Yo photocopy the staré may also be secured rom ia Copyright Ciarance Cena, 222 ‘Rosewood Dive, Caer, MA 1823 Te (978) 686-2600 DwnLcOpyON. CON