ASTM_D_5151_-_19.pdf

Designation:D515119Standard Test Method forDetection of Holes in Medical Gloves1This standard is issued under the fixed designation D5151;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers the detection of holes inmedical gloves.1.2 This test method is limited to the detection of holes thatallow water leakage under the conditions of the test.1.3 The smallest hole size that will allow water leakage in amedical glove has not been determined and is beyond the scopeof this test method.1.4 The safe and proper use of medical gloves is beyond thescope of this test method.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 medical gloves,nmedical gloves,as used in this testmethod,refer to both surgical and examination gloves.3.Significance and Use3.1 This test method is designed to detect holes that leakwater and thereby compromise the usefulness of the glove.3.2 This test method is suitable and designed as a referencemethod to evaluate samples of medical gloves.4.Apparatus4.1 MandrelA clear plastic tube,nominally 6 6 0.5 cmoutside diameter,5 cm inside diameter or 50 mm schedule 80poly(vinyl chloride)(PVC)pipe,38 6 1 cm long.The mandrelshall have a clamp or rubber band for securing the glove to themandrel.4.2 Graduated Cylinder or BeakerAs a minimum,thegraduated cylinder or beaker shall be marked in increments of50 cm3to a capacity of 1000 cm3.The markings shall beaccurate to within 610 cm3at volumes greater than 500 cm3.4.3 Stopwatch.4.4 Various Clamps,Hangers,and Stands.5.Reagents5.1 Tap WaterThe water used in this test method shall beclean and free from any visible contaminants.6.Procedure6.1 Throughout 6.2 and 6.3,ensure that the exterior of theglove remains dry.6.2 Mount the mandrel in a vertical position using appro-priate stands,clamps,and hangers.Affix the glove to themandrel by stretching the cuff of the glove around the mandrel.A maximum 40 mm of glove cuff should fit over the bottomend of the mandrel.Use the securing device,as necessary,tohold the glove in place.The remainder of the glove shouldhang freely from the mandrel when filled with water.6.3 Pour a minimum of 1000 cm3of room temperaturewater(that is,20 to 30C)into the top of the mandrel.Thewater shall pass freely into the glove.6.4 Visually inspect the glove for immediate water leakage.Let the glove hang for 2 min and again inspect for waterleakage.7.Interpretation of Results7.1 Any glove that shows a droplet,stream,or other type ofwater leakage shall be considered to have failed the test.7.2 Water leakage above the junction of the glove cuff andmandrel is not a test failure.If this leakage occurs,remove anddry the outside of the glove and retest.1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Oct.1,2019.Published October 2019.Originallyapproved in 1990.Last previous edition approved in 2015 as D5151 06(2015).DOI:10.1520/D5151-19.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 8.Report8.1 The report shall include the number of samples tested,the number of failures,and a general description of the locationof each hole.9.Precision and Bias9.1 No statement is made about either the precision or biasof this test method.This is a“pass-fail”test procedure notsubject to the usual analysis for quantitative variable precision.10.Keywords10.1 detection;gloves;holes;medicalASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard.Us