ASTM_D_3899_-_93e2.pdf

Designation:D 3899 93e2Standard Specification forRubber ContraceptivesVaginal Diaphragms1This standard is issued under the fixed designation D 3899;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(e)indicates an editorial change since the last revision or reapproval.e2NOTEEditorial corrections were made to Sections 1.2 and 4 in February 1999.1.Scope1.1 This specification covers requirements for contraceptivevaginal diaphragms,hereafter called diaphragms.1.2 Vaginal barrier devices known as cervical caps,vaginalsponges and female condoms are not included in this specifi-cation.2.Referenced Documents2.1 ASTM Standards:D 412 Test Methods for Vulcanized Rubber and Thermo-plastic Rubbers and Thermoplastic ElastomersTension2D 573 Test Method for RubberDeterioration in an AirOven2D 3040 Practice for Preparing Precision Statements forStandards Related to Rubber and Rubber Testing3D 3767 Practice for RubberMeasurement of Dimensions22.2ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes42.3 Federal Regulations:U.S.Code of Federal Regulations,Title 21,Food and DrugAdministration,Section 177.2600,Rubber Articles In-tended for Repeated Use53.Classification3.1 The following types of diaphragms are covered by thisspecification:3.1.1 Type 1Coil spring diaphragm.3.1.2 Type 2Flat spring diaphragm(also called watchspring or Mensinga diaphragm).3.1.3 Type 3Arching or bow-bend diaphragm.4.Materials and Manufacture4.1 Diaphragms shall be made of an elastic polymer with arim reinforced with metal or other suitable material.Thediaphragm dressing material,compounding materials,and rimreinforcing material shall not have a deleterious effect on therubber or be harmful to the user under normal conditions ofuse.Materials used should be permitted by the Code of FederalRegulations,Title 21,Section 177.2600.4.2 Construction:4.2.1 The diaphragm shall consist of a dome and an integralperipheral rim.The dome and rubber portion of the rim shall beone continuous film.4.2.2 The rim of the diaphragm may be reinforced with aspring,either helically wound or flat leaf construction,whichshall be sufficiently rigid to hold the rim in a flat,circularposition.4.2.3 The reinforcing spring shall be encapsulated com-pletely and located centrally within the rim so that the springshall not be exposed under normal conditions of use.4.2.4 The ends of any spring shall be joined so that they willnot project through the surface of the rim when encapsulated.5.Physical Requirements5.1 Rim and Spring Compression:5.1.1 When the sides of the diaphragm are compressedacross the diameter of the rim as described in Annex A1,therim shall be substantially in the same plane and shall not havea deviation greater than 20.NOTE1This test is only applicable to diaphragms with springs of flatleaf construction(Type 2).5.1.2 When the sides of a diaphragm are compressed acrossthe diameter of the rim by a suspended mass of 280 g,asdescribed in Annex A2,the diameter shall be between 55 and78%of the original diameter.See Note 2.NOTE2This test is not applicable to diaphragms with springs de-signed to form an arc when compressed.5.1.3 Precision and BiasA precision and bias statement isnot applicable since the results merely indicate whether there isconformance to the criteria specified in the procedure.5.2 Tensile Strength and Elongation at Break of Rubber:5.2.1 The rubber in the dome shall comply with the follow-1This specification is under the jurisdiction of ASTM Committee D-11 onRubber and is the direct responsibility of Subcommittee D11.40 on ConsumerRubber Products.Current edition approved Sept.15,1993.Published November 1993.Originallypublished as D 3899 87.Last previous edition D 3899 87.2Annual Book of ASTM Standards,Vol 09.01.3Discontinuedsee 1986 Annual Book of ASTM Standards,Vols 09.01 and09.02.4Available from American National Standards Institute,11 W.42nd St.,13thFloor,New York,NY 10036.5Available from the Superintendent of Documents,U.S.Government PrintingOffice,Washington,DC 20402.1AMERICAN SOCIETY FOR TESTING AND MATERIALS100 Barr Harbor Dr.,West Conshohocken,PA 19428Reprinted from the Annual Book of ASTM Standards.Copyright ASTMNOTICE:This standard has either been superseded and replaced by a new version or discontinued.Contact ASTM International(www.astm.org)for the latest information.ing requirements when tested in accordance with 5.2.1.1:Tensile strength,min,15 MPaElongation at break,min,650%5.2.1.1 A ring specimen having a mean circumference of100.0 6 0.5 mm and a radial width of 2.00 6 0.02 mm shallbe cut with a die from each diaphragm.The specimens shall betested in accordance with Test Methods D 412.The internalcircumference shall be used for calculation of elongation atbreak.5.2.2 After accelerated aging under the conditions specifiedin 5.2.2.1,the tensile stren