1、Designation: D 6976 08Standard Specification forRubber ContraceptivesVaginal Diaphragms1This standard is issued under the fixed designation D 6976; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number
2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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
3、 cervical caps, vaginalsponges and female condoms are not included in this specifi-cation.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3767 Practice for RubberMeasureme
4、nt of Dimensions2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.3 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
5、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 reinfo
6、rced 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 FederalRegulation
7、s, 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
8、, 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 tha
9、t 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 ha
10、vea deviation greater than 20.NOTE 1Tests 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).5.1.2 When the sides of a diaphrag
11、m 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 the 1000thcompression, the
12、compression resistance and degree of twistmeasurements are repeated. The diameter along the axis ofcompression shall be at least 90 % of the original value and thedegree of twist shall not be greater than 20.NOTE 2Manufacturers of diaphragms who are certified to a qualitymanagement system, ISO 9000
13、or equivalent, whose suppliers aresimilarly certified may use the repeated compression testing part of this1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Jan. 1, 2
14、008. Published January 2008. Originallyapproved in 2003. Last previous edition approved in 2003 as D 6976 03.2For 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 sta
15、ndards 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 1
16、9111-50981Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.method as a qualification or type test. In that case, lot by lot testing shallconsist of a single compression and the measurement of the compressionresistance.5.1.4 Precision a
17、nd 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-ing requirements when teste
18、d 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
19、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 strength and elongation at break shall beat least 75 % of the value before aging.5.2.2.1 Condition the diaphragms at 70 6 2C for 16
20、6 6 2h in accordance with Test Method D 573. Do not age dia-phragms of different compositions simultaneously in the sameoven. After aging, condition the diaphragms at 23 6 2C fornot less than 16 h, and prepare and test the specimens within 96h in accordance with Test Methods D 412. Manufacturers may
21、use process control tests to determine suitable shelf life butaccelerated aging at 70C and 166 h shall be used forqualification tests and referee tests.5.2.3 Precision and BiasThe precision and bias of deter-mining tensile strength and ultimate elongation of diaphragmdome rubber are as specified in
22、Test Methods D 412.6. Dimensions, Requirements, and Permissible Variations6.1 Diameter:6.1.1 The following diameters are standard sizes: 55, 60, 65,70, 75, 80, 85, 90, 95, and 100 mm.6.1.2 The size of the diaphragm shall be the nominalexternal diameter of the rim in accordance with 6.1.1. Theactual
23、diameter shall conform to the standard size within 62mm.6.1.3 The actual diameter shall be determined by measure-ment of the external diameter at two positions perpendicular toeach other. The difference between these two measurementsshall not exceed 2 mm. Alternatively, go-no-go devices may beused t
24、o determine compliance with 6.1.2.6.2 Thickness:6.2.1 The thickness of the dome shall not be less than 0.2mm.6.2.2 Measure the thickness of the dome at five locationsusing a dial micrometer in accordance with Practice D 3767and accurate to 0.01 mm.6.2.3 Precision and BiasThe precision and bias of me
25、a-suring diaphragm dimensions are as specified in PracticeD 3767.7. Workmanship, Finish and Appearance7.1 The diaphragm dome shall have a uniform, smoothfinish and be free of holes, thin spots, air bubbles, embeddedparticles, and other defects likely to affect serviceability.Inspection shall be made
26、 under bright lumination in accordancewith Annex A3. The dome shall not be sticky when touched.7.2 The diaphragm rim shall have a smooth surface, and thereinforcing material shall be encapsulated completely. Thesurface of the rim shall not be sticky when touched.8. Sampling and Inspection8.1 Follow
27、the sampling procedure in ISO 2859 usingGeneral Inspection Level I and an acceptable quality level(AQL) of 1.5 for inspection for dimensions, rim and springcompression, tensile strength and elongation at break, andworkmanship (Sections 5, 6, and 7). The compliance level shallbe an AQL of 0.4 for the
28、 following major defects, (a) hole inthe dome, (b) exposed spring, (c) broken spring, (d) illegiblemarking on the diaphragm, and (e) illegible labeling.9. Product Marking9.1 Diaphragm IdentificationEach diaphragm shall bemarked legibly with the manufacturers name or recognizedtrademark and its size
29、in accordance with 6.1.1.9.2 Package IdentificationEach packaged diaphragmshall be marked legibly with the following information:9.2.1 Name or trademark of manufacturer,9.2.2 Identifying code of manufacturer,9.2.3 Size of diaphragm, and9.2.4 Date of manufacture or of expiration.10. Packaging and Pac
30、kage Marking10.1 Individual Diaphragm:10.1.1 Each diaphragm shall be packaged individually in acontainer that protects the contents from mechanical damageduring normal handling, transit, and storage.10.1.2 Each diaphragm package shall contain instructionsfor the use, care, and storage of the diaphra
31、gm.10.2 Outer Container(s)A convenient number of indi-vidual packages shall be packaged in one or more outercontainers, which shall be sufficiently strong to protect thecontents during transit and storage.11. Keywords11.1 contraceptives; diaphragms; rubber; vaginalD6976082ANNEXES(Mandatory Informati
32、on)A1. METHOD OF OPERATION FOR FIGURE EIGHT TESTA1.1 Compress the diaphragm between two metal rods,each provided with a cavity to fit the rim (see Fig. A1.1). Onerod, A, is movable along its axis, but cannot rotate. The otherrod, B, is not movable along its axis, but can rotate freely.A1.2 Compress
33、the diaphragm by pushing it forward usingHandle C to a fixed distance between RodsAand B, dependingupon the size of the diaphragm (see Table A1.1). In thisposition, measure the possible turn of Rod B by using thepointer, D, affixed to it.A1.3 Spindle E is provided for permanent setting of thedistanc
34、e between Rods A and B for each size diaphragm.FIG. A1.1 Figure Eight Diaphragm TesterTABLE A1.1 Rod SeparationSize of Diaphragm,mmDistance Between Rods,mm55 21.560 22.565 23.570 24.575 25.580 26.585 27.590 28.595 29.5100 30.5D6976083A2. METHOD OF OPERATION FOR COMPRESSION TESTERA2.1 Place the diaph
35、ragm, A, on top of Rods E and F asnoted in Fig. A2.1. Hook Rod B over the diaphragm. WhenRod B is released, the diaphragm will compress across itsdiameter, between the top of Rod B and Rods E and F.A2.2 Note the dimensional change on the attached scale, C.NOTE A2.1Slotted Guide G is affixed to the t
36、esting device and holdsRod B in a vertical position.FIG. A2.1 Compression TestD6976084A3. METHOD OF OPERATION FOR DIAPHRAGM INSPECTIONA3.1 Hold the diaphragm in the hand, and pull the dome ofthe diaphragm over the glass cylinder with the light sourceunderneath the glass (see Fig. A3.1).A3.2 Move the
37、 diaphragm around and inspect it forobjectionable defects.FIG. A3.1 Diaphragm Inspection LampD6976085ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that det
38、ermination of the validity of any such patent rights, and the riskof 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 every five years andif not revised, either reapproved o
39、r withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel th
40、at your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).D6976086
