1、Designation: D6976 08D6976 13Standard 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
2、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 contraceptive vaginal diaphragms, hereafter called diaphragms.1.2 Vaginal barrier devices kn
3、own as cervical caps, vaginal sponges and female condoms are not included in this specification.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTensionD573 Test Method for RubberDeterioration in an Air OvenD3767 Practice for RubberMeasur
4、ement of Dimensions2.2 ISO Standard:Standards:3ISO 2859 Sampling Procedures and Tables for Inspection by AttributesISO 10993 Biological Evaluation of Medical Devices2.3 Federal Regulations:U.S. Code of Federal Regulations, Title 21, Food and Drug Administration, Section 177.2600, Rubber Articles Int
5、ended forRepeated Use43. Classification3.1 The following types of diaphragms are covered by this specification:3.1.1 Type 1Coil spring diaphragm.3.1.2 Type 2Flat spring diaphragm (also called watch spring or Mensinga diaphragm).3.1.3 Type 3Arching or bow-bend diaphragm.4. Materials and Manufacture4.
6、1 Diaphragms shall be made of an elastic polymer with a rim reinforced with metal or other suitable material. The diaphragmdressing material, compounding materials, and rim reinforcing material shall not have a deleterious effect on the rubber or beharmful to the user under normal conditions of use.
7、 Manufacturers should evaluate the cytotoxicity, sensitization, irritation, andacute systemic toxicity potential of the diaphragm per ISO 10993. 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 do
8、me and an integral peripheral 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 a spring, either helically wound or flat leaf construction, which shallbe sufficiently rigid to hold the rim in a flat, circular position.4.2.3
9、The reinforcing spring shall be encapsulated completely and located centrally within the rim so that the spring shall notbe exposed under normal conditions of use.4.2.4 The ends of any spring shall be joined so that they will not project through the surface of the rim when encapsulated.1 This specif
10、ication is under the jurisdiction of ASTM Committee D11 on Rubber and is the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved Jan. 1, 2008May 1, 2013. Published January 2008May 2013. Originally approved in 2003. Last previous edition approved in 20032
11、008 asD6976 03.D6976 08. DOI: 10.1520/D6976-08.10.1520/D6976-13.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM websi
12、te.3 Available from International Organization for Standardization (ISO), 1 rue de Varemb, Case postale 56, CH-1211, Geneva 20, Switzerland.4 Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098This document is not an ASTM sta
13、ndard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cas
14、es only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Physical Requirements5.1 Rim and Spring Compression:5.1.1 When the sides of t
15、he diaphragm are compressed across the diameter of the rim as described in Annex A1, the rim shallbe substantially in the same plane and shall not have a deviation greater than 20.NOTE 1Tests 5.1.1 and 5.1.2 are only applicable to diaphragms with springs of coil construction (Type 1) or flat leaf co
16、nstruction (Type 2) and arenot applicable to diaphragms with springs designed to form an arc when compressed (Type 3).5.1.2 When the sides of a diaphragm are compressed across the diameter of the rim by a suspended mass of 280 g, as describedin Annex A2, the diameter shall be between 55 and 78 % of
17、the original diameter.5.1.3 When the diaphragms are repeatedly compressed to 25 % of their original diameter and released after the 1000thcompression, the compression resistance and degree of twist measurements are repeated. The diameter along the axis ofcompression shall be at least 90 % of the ori
18、ginal value and the degree of twist shall not be greater than 20.NOTE 2Manufacturers of diaphragms who are certified to a quality management system, ISO 9000 or equivalent, whose suppliers are similarlycertified may use the repeated compression testing part of this method as a qualification or type
19、test. In that case, lot by lot testing shall consist of a singlecompression and the measurement of the compression resistance.5.1.4 Precision and BiasA precision and bias statement is not applicable since the results merely indicate whether there isconformance to the criteria specified in the proced
20、ure.5.2 Tensile Strength and Elongation at Break of Rubber:5.2.1 The rubber in the dome shall comply with the following 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 of 100.0 6 0.5 m
21、m and a radial width of 2.00 6 0.02 mm shall be cutwith a die from each diaphragm. The specimens shall be tested in accordance with Test Methods D412. The internal circumferenceshall be used for calculation of elongation at break.5.2.2 After accelerated aging under the conditions specified in 5.2.2.
22、1, the tensile strength and elongation at break shall be atleast 75 % of the value before aging.5.2.2.1 Condition the diaphragms at 70 6 2C for 166 6 2 h in accordance with Test Method D573. Do not age diaphragmsof different compositions simultaneously in the same oven. After aging, condition the di
23、aphragms at 23 6 2C for not less than16 h, and prepare and test the specimens within 96 h in accordance with Test Methods D412. Manufacturers may use processcontrol tests to determine suitable shelf life but accelerated aging at 70C and 166 h shall be used for qualification tests and refereetests.5.
24、2.3 Precision and BiasThe precision and bias of deter- mining tensile strength and ultimate elongation of diaphragm domerubber are as specified in Test Methods D412.6. Dimensions, Requirements, and Permissible Variations6.1 Diameter:6.1.1 The following diameters are standard sizes: 55, 60, 65, 70, 7
25、5, 80, 85, 90, 95, and 100 mm.6.1.2 The size of the diaphragm shall be the nominal external diameter of the rim in accordance with 6.1.1. The actual diametershall conform to the standard size within 62 mm.6.1.3 The actual diameter shall be determined by measurement of the external diameter at two po
26、sitions perpendicular to eachother. The difference between these two measurements shall not exceed 2 mm. Alternatively, go-no-go devices may be used todetermine compliance with 6.1.2.6.2 Thickness:6.2.1 The thickness of the dome shall not be less than 0.2 mm.6.2.2 Measure the thickness of the dome a
27、t five locations using a dial micrometer in accordance with Practice D3767 andaccurate to 0.01 mm.6.2.3 Precision and BiasThe precision and bias of measuring diaphragm dimensions are as specified in Practice D3767.7. Workmanship, Finish, and Appearance7.1 The diaphragm dome shall have a uniform, smo
28、oth finish and be free of holes, thin spots, air bubbles, embedded particles,and other defects likely to affect serviceability. Inspection shall be made under bright lumination in accordance with Annex A3.The dome shall not be sticky when touched.7.2 The diaphragm rim shall have a smooth surface, an
29、d the reinforcing material shall be encapsulated completely. The surfaceof the rim shall not be sticky when touched.D6976 1328. Sampling and Inspection8.1 Follow the sampling procedure in ISO 2859 using General Inspection Level I and an acceptable quality level (AQL) of 1.5for inspection for dimensi
30、ons, rim and spring compression, tensile strength and elongation at break, and workmanship (Sections5, 6, and 7). The compliance level shall be anAQLof 0.4 for the following major defects, (a) hole in the dome, (b) exposed spring,(c) broken spring, (d) illegible marking on the diaphragm, and (e) ill
31、egible labeling.9. Product Marking9.1 Diaphragm IdentificationEach diaphragm shall be marked legibly with the manufacturers name or recognized trademarkand its size in accordance with 6.1.1.9.2 Package IdentificationEach packaged diaphragm shall be marked legibly with the following information:9.2.1
32、 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.expiration per results of testing completed per 5.2.2.1.10. Packaging and Package Marking10.1 Individual Diaphragm:10.1.1 Each diaphragm shall be packaged
33、individually in a container that protects the contents from mechanical damage duringnormal handling, transit, and storage.10.1.2 Each diaphragm package shall contain instructions for the use, care, and storage of the diaphragm.10.2 Outer Container(s)A convenient number of individual packages shall b
34、e packaged in one or more outer containers,which shall be sufficiently strong to protect the contents during transit and storage.11. Report11.1 Report the following information for the tests described in 5.1, 5.2, 6.1, and 6.2:11.1.1 Sample identification.11.1.2 Date of testing.11.1.3 Name and addre
35、ss of test laboratory.11.1.4 Reference to relevant standards.11.1.5 Test results.11.1.6 Precision and bias per 5.2.3 and 6.2.3.11.1.7 Date of test report.12. Keywords12.1 contraceptives; diaphragms; rubber; vaginalANNEXES(Mandatory Information)A1. METHOD OF OPERATION FOR FIGURE EIGHT TESTA1.1 Compre
36、ss the diaphragm between two metal rods, each provided with a cavity to fit the rim (see Fig. A1.1). One rod, A, ismovable along its axis, but cannot rotate. The other rod, B, is not movable along its axis, but can rotate freely.A1.2 Compress the diaphragm by pushing it forward using Handle C to a f
37、ixed distance between Rods A and B, depending uponthe size of the diaphragm (see Table A1.1). In this position, measure the possible turn of Rod B by using the pointer, D, affixedto it.A1.3 Spindle E is provided for permanent setting of the distance between Rods A and B for each size diaphragm.D6976
38、 133A2. METHOD OF OPERATION FOR COMPRESSION TESTERA2.1 Place the diaphragm, A, on top of Rods E and F as noted in Fig. A2.1. Hook Rod B over the diaphragm. When Rod B isreleased, the diaphragm will compress across its diameter, between the top of Rod B and Rods E and F.A2.2 Note the dimensional chan
39、ge on the attached scale, C.NOTE A2.1Slotted Guide G is affixed to the testing device and holds Rod B in a vertical position.FIG. A1.1 Figure Eight Diaphragm TesterTABLE A1.1 Rod SeparationSize of Diaphragm,mmDistance BetweenRods,mm55 21.560 22.565 23.570 24.575 25.580 26.585 27.590 28.595 29.5100 3
40、0.5D6976 134FIG. A2.1 Compression TestD6976 135A3. METHOD OF OPERATION FOR DIAPHRAGM INSPECTIONA3.1 Hold the diaphragm in the hand, and pull the dome of the diaphragm over the glass cylinder with the light source underneaththe glass (see Fig. A3.1).FIG. A3.1 Diaphragm Inspection LampD6976 136A3.2 Mo
41、ve the diaphragm around and inspect it for objectionable defects.D6976 137ASTM 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 determination of the validity
42、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 or withdrawn.Your comments a
43、re 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 that your comments have not re
44、ceived 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)
45、 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).D6976 138
