ASTM_D_6976_-_13_2018.pdf

Designation:D697613(Reapproved 2018)Standard Specification forRubber ContraceptivesVaginal Diaphragms1This standard is issued under the fixed designation D6976;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 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.1.3 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.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3767 Practice for RubberMeasurement of Dimensions2.2 ISO Standards:3ISO 2859 Sampling Procedures and Tables for Inspection byAttributesISO 10993 Biological Evaluation of Medical Devices2.3 Federal Regulations:U.S.Code of Federal Regulations,Title 21,Food and DrugAdministration,Section 177.2600,Rubber Articles In-tended for Repeated Use43.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.Manufacturersshouldevaluatethecytotoxicity,sensitization,irritation,and acute systemic toxicity potential ofthe diaphragm per ISO 10993.Materials used should bepermitted by the Code of Federal Regulations,Title 21,Section177.2600.4.2 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.NOTE1Tests 5.1.1 and 5.1.2 are only applicable to diaphragms withsprings of coil construction(Type 1)or flat leaf construction(Type 2)andare not applicable to diaphragms with springs designed to form an arcwhen compressed(Type 3).1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Sept.1,2018.Published November 2018.Originallyapproved in 2003.Last previous edition approved in 2013 as D6976 13.DOI:10.1520/D6976-13R18.2For 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 International Organization for Standardization(ISO),1 rue deVaremb,Case postale 56,CH-1211,Geneva 20,Switzerland.4Available from Standardization Documents Order Desk,DODSSP,Bldg.4,Section D,700 Robbins Ave.,Philadelphia,PA 19111-5098Copyright 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 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.5.1.3 When the diaphragms are repeatedly compressed to25%of their original diameter and released after