Designation:D5151–06
Standard Test Method for
Detection of Holes in Medical Gloves1
This standard is issued under thefixed designation D5151;the number immediately following the designation indicates the year of original adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.A superscript epsilon(e)indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1.Scope
1.1This test method covers the detection of holes in medical gloves.盖形螺母
1.2This test method is limited to the detection of holes that allow water leakage under the conditions of the test.
分凝器1.3The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method.
1.4The safe and proper use of medical gloves is beyond the scope of this test method.
1.5The values stated in SI units are to be regarded as standard.No other units of measurement are included in this standard.
1.6This standard 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 safety and health practices and determine the applica-bility of regulatory limitations prior to use.
2.Terminology
2.1Definitions of Terms Specific to This Standard:
2.1.1medical gloves,n—medical gloves,as used in this test method,refer to both surgical and examination gloves.
3.Significance and Use
煤气阀3.1This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove.
药用淀粉3.2This test method is suitable and designed as a reference method to evaluate samples of medical gloves. 4.Apparatus狐臭膏
4.1Mandrel—A clear plastic tube,nominally660.5cm outside diameter,5cm inside diameter or50mm schedule80 poly(vinyl chloride)(PVC)pipe,3861cm long.The mandrel shall have a clamp or rubber band for securing the glove to the mandrel.
4.2Graduated Cylinder or Beaker—As a minimum,the graduated cylinder or beaker shall be marked i
n increments of 50cm3to a capacity of1000cm3.The markings shall be accurate to within610cm3at volumes greater than500cm3.
4.3Stopwatch.
4.4Various Clamps,Hangers,and Stands.
5.Reagents
5.1Tap Water—The water used in this test method shall be clean and free from any visible contaminants.
6.Procedure
6.1Throughout6.2and6.3,ensure that the exterior of the glove remains dry.
6.2Mount the mandrel in a vertical position using appro-priate stands,clamps,and hangers.Affix the glove to the mandrel by stretching the cuff of the glove around the mandrel.
A maximum40mm of glove cuff shouldfit over the bottom end of the mandrel.Use the securing device,
as necessary,to hold the glove in place.The remainder of the glove should hang freely from the mandrel whenfilled with water.
6.3Pour a minimum of1000cm3of water having a room temperature of15to30°C into the top of the mandrel.The water shall pass freely into the glove.
6.4Visually inspect the glove for immediate water leakage. Let the glove hang for2min and again inspect for water leakage.
7.Interpretation of Results
7.1Any glove that shows a droplet,stream,or other type of water leakage shall be considered to have failed the test.
7.2Water leakage above the junction of the glove cuff and mandrel is not a test failure.If this leakage occurs,remove and dry the outside of the glove and retest.
8.Report
8.1The report shall include the number of samples tested, the number of failures,and a general description of the location of each hole.
1This test method is under the jurisdiction of ASTM Committee D11on Rubber
and is the direct responsibility of Subcommittee D11.40on Consumer Rubber
Products.
Current edition approved Dec.15,2006.Published January2007.Originally
approved in1990.Last previous edition approved in2006as D5151–99(2006).
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Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959,United States.
9.Precision and Bias
9.1No statement is made about either the precision or bias of this test method.This is a“pass-fail”test procedure not subject to the usual analysis for quantitative variable precision.10.Keywords
10.1detection;gloves;holes;medical
ASTM International takes no position respecting the validity of any patent rights asserted in connecti
on with any item mentioned in this standard.Users of this standard are expressly advised that determination of the validity of any such patent rights,and the risk of infringement of such rights,are entirely their own responsibility.
This standard is subject to revision at any time by the responsible technical committee and must be reviewed everyfive years and if not revised,either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.Your comments will receive careful consideration at a meeting of the responsible technical committee,which you may attend.If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards,at the address shown below.
This standard is copyrighted by ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959, United States.Individual reprints(single or multiple copies)of this standard may be obtained by contacting ASTM at the above address or at610-832-9585(phone),610-832-9555(fax),or (e-mail);or through the ASTM website
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