ASTM_D_3579_-_77_2016.pdf

Designation:D357977(Reapproved 2016)Standard Specification forRubber Surgical Drainage Tubes,Penrose-Type1This standard is issued under the fixed designation D3579;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 specification covers Penrose-type rubber tubesused in performing certain surgical drainage procedures.1.2 The specification provides for packaged sterile rubbertubes and packaged or bulk nonsterile rubber tubes.1.3 This standard does not purport to address all of thesafety problems,if any,associated with its use.It is theresponsibility 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.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOven2.2 Other Documents:3ISO 2859 Sampling Procedures and Tables for Inspection byAttributes3.Significance and Use3.1 This specification is intended as a reference to theperformance and safety of rubber surgical drainage tubes.Thesafe and proper use of rubber surgical drainage tubes is beyondthe scope of this standard.4.Materials and Manufacture4.1 Any rubber polymer compound that permits the tube tomeet the requirements of this standard.4.2 Absorbable dusting powder that meets the current re-quirements of the U.S.Pharmacopoeia may be applied to thetube.4.3 X-ray opaque materials that permit the tube to meet therequirements of this specification may be added to the rubberpolymer compound.5.Sampling5.1 For referee purposes,tubes shall be sampled and in-spected in accordance with ISO 2859.The inspection levelsand acceptable quality levels(AQL)shall conform to thosespecified in Table 1,or as agreed between the purchaser and theseller,if the latter is more comprehensive.6.Performance6.1 As necessary,tubes sampled according to Section 5 shallbe subject to inspection and tests to meet the following refereeperformance requirements:6.1.1 Comply with requirements for sterility when tested inaccordance with 7.2.6.1.2 Comply with requirements for safety when tested inaccordance with 7.3.6.1.3 Be X-ray opaque when tested in accordance with 7.4.6.1.4 Have consistent physical dimensions in accordancewith 7.5.6.1.5 Have acceptable physical property characteristics inaccordance with 7.6.7.Referee Test Methods7.1 The following tests shall be conducted to assure thenecessary requirements of Section 6 as specified in Table 1.7.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of the U.S.Pharmacopoeia.7.3 Safety TestTesting for safety shall be conducted inaccordance with the latest revision of the U.S.Pharmacopoeia,for transfusion and infusion assemblies.7.4 X-ray Opaque TestSelect at least two tubes from eachlot and radiograph as follows:Place a small foreign body of notless than 0.5-mm thick sheet lead under each tube.Superim-pose 240 6 10 mm of USP paraffin over the tubes.Use astandard make of cassette with screens,films,and processingsolutions.Expose at a setting of 85 kV,10 mAs and from a1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved June 1,2016.Published July 2016.Originally approvedin 1977.Last previous edition approved in 2010 as D3579 77(2010).DOI:10.1520/D3579-77R16.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 distance of 640 6 10 mm.The tubes shall show a definite,uniform shadow,and the degree of opaqueness shall show theshadow of the foreign body.7.5 Physical Dimensions Test:7.5.1 The tubes shall comply with the dimension require-ments specified in Table 2.7.5.2 The length shall be expressed in millimetres as mea-sured from end to end and parallel to the axis of the tube.7.5.3 The flat width of the tube shall be expressed inmillimetres as measured at a right angle to the axis of the tube.Three random measurements shall be taken and averaged.Theaverage dimension shall be within the tolerance requirementsspecified in Table 2.7.5.4 The minimum wall thickness shall be expressed inmillimetres as specified in Table 2 when using a dial microm-eter described in Test Methods D412.Three random measure-ments shall be taken along the axis of th