ASTM D6976-2003 Standard Specification for Rubber Contraceptives&8212 Vaginal Diaphragms《橡胶避孕套标准规范 阴道膜》.pdf

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1、Designation: D 6976 03Standard 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 DimensionsD 4483 Practice for Determining Precision for Test MethodStandards in the Rubber and Carbon Black Industries2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.3 Federal Regulations:U.S. Code of Federal Regulations, Title 21, Food and DrugAdministra

5、tion, 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-be

6、nd 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

7、 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

8、.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 s

9、pringshall 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 di

10、ameter of the rim as described in Annex A1, therim shall be substantially in the same plane and shall not havea 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 t

11、o diaphragms with springs designed to form an arcwhen compressed (Type 3).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 diaphragm

12、s are repeatedly compressed to25 % of their original diameter and released after the 1000thcompression, the 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

13、greater than 20.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov. 1, 2003. Published December 2003.2For referenced ASTM standards, visit the ASTM website, www.as

14、tm.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,

15、Switzerland.4Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-50981Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.NOTE 2Manufacturers of diaphragms who are certi

16、fied to a qualitymanagement system, ISO 9000 or equivalent, whose suppliers aresimilarly certified may use the repeated compression testing part of thismethod as a qualification or type test. In that case, lot by lot testing shallconsist of a single compression and the measurement of the compression

17、resistance.5.1.4 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

18、-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 a

19、ccordance 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 strength and elongation at break shall beat least 75 % of the value before aging.5.2.2.1 Condition the

20、diaphragms at 70 6 2C for 166 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 Meth

21、ods D 412. Manufacturers mayuse 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

22、 rubber are as specified in 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 accor

23、dance with 6.1.1. Theactual 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, g

24、o-no-go devices may beused to 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 Bias

25、The precision and bias of mea-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 serviceabil

26、ity.Inspection shall be made 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. Sampli

27、ng and Inspection8.1 Follow 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 s

28、hallbe an AQL of 0.4 for the 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 recog

29、nizedtrademark and its size 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 expi

30、ration.10. Packaging and Package 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

31、, and storage of the diaphragm.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; vaginalD697603

32、2ANNEXES(Mandatory Information)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

33、rotate freely.A1.2 Compress 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 per

34、manent setting of thedistance 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,mm50 20.555 21.560 22.565 23.570 24.575 25.580 26.585 27.590 28.595 29.5100 30.5105 31.5D6976033A2. METHOD OF OPERATION

35、 FOR COMPRESSION TESTERA2.1 Place the diaphragm, 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.N

36、OTE A2.1Slotted Guide G is affixed to the testing device and holdsRod B in a vertical position.FIG. A2.1 Compression TestD6976034A3. 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 sourceunderne

37、ath the glass (see Fig. A3.1).A3.2 Move the diaphragm around and inspect it forobjectionable defects.FIG. A3.1 Diaphragm Inspection LampD6976035ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of t

38、his standard are expressly advised that determination 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 y

39、ears andif not revised, either reapproved or 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 comm

40、ittee, which you may attend. If you feel that 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).D6976036