ASTM D3492-2016 Standard Specification for Rubber Contraceptives (Male Condoms)《橡胶避孕套 (男性用避孕套) 的标准规格》.pdf

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1、Designation: D3492 15D3492 16Standard Specification forRubber Contraceptives (Male Condoms)1This standard is issued under the fixed designation D3492; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A num

2、ber in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the U.S. Department of Defense.1. Scope1.1 This specification covers the minimum requirements f

3、or individually packaged male condoms made from natural rubberlatex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials thatmay be applied to condoms except as noted in 3.2.1.2 This specification is intended to assist buyers in

4、 obtaining condoms of consistent quality. The safe and proper use ofcondoms is excluded from the scope of this specification.1.3 The applicability of this specification is as a design guideline and a reference test specification. It is not intended to be aroutine quality control specification for co

5、ndom manufacturing operations.1.4 The annexes in this specification include important information, such as that on apparatus or materials, that is a mandatorypart of the specification but too detailed for inclusion in the main text.1.5 The appendixes in this specification contain information intende

6、d to provide guidance only and are not a mandatory partof the specification.1.6 It shall be the responsibility of the manufacturer for any condom design that falls outside the specifications of this standardto determine testing methodology and substantiate the appropriateness of that methodology to

7、assure the quality of the condomsto the purchaser and to the government regulatory authority having jurisdiction.1.7 Regulatory bodies may require additional information, such as clinical data, to support the condom sizes subject to thisstandard.1.8 The values stated in SI units are to be regarded a

8、s the standard. The values given in parentheses are for information only.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTensionD573 Test Method for RubberDeterioration in an Air OvenD1076 Specification for RubberConcentrated, Ammonia Pr

9、eserved, Creamed, and Centrifuged Natural LatexD3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionD3767 Practice for RubberMeasurement of DimensionsD4483 Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industr

10、iesE177 Practice for Use of the Terms Precision and Bias in ASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method2.2 ISO Standard:3ISO 4074 Natural Latex Rubber Condoms Requirements and Test MethodsISO 10993 Biological Evaluations of Medic

11、al Devices2.3 Other Document:3ANSI/MIL-STD 105E Sampling Procedures and Tables for Inspection by Attributes1 This specification is under the jurisdiction ofASTM Committee D11 on Rubber and is the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved June 1

12、, 2015July 1, 2016. Published October 2015August 2016. Originally approved in 1976. Last previous edition approved in 20142015 asD3492 14.D3492 15. DOI: 10.1520/D3492-15.10.1520/D3492-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceas

13、tm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.This document is not an ASTM standard and is intended only to pro

14、vide 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 cases only the current versionof the

15、 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 States13. Materials and Manufacture3.1 Condoms shall be manufactured from natural rubber latex conforming to Specificati

16、on D1076.3.2 The condoms and any dressing materials applied to them shall not liberate substances that are known to be toxic, sensitizing,locally irritating, or otherwise harmful to the general population under normal conditions of use.NOTE 1Natural rubber latex products are known to cause irritatio

17、n or sensitivity in a small proportion of the user population.NOTE 2Condom lubricants that contain Nonoxynol 9 spermicide are known to cause irritation in a small proportion of the user population.NOTE 3ISO 10993 contains methods to evaluate the biocompatibility of natural rubber latex condoms.4. Re

18、quirements4.1 General:4.1.1 SamplingSamples will be selected randomly from the defined “lot.” The sampling plan must conform to therequirements listed in Table 1.4.1.2 Sample HandlingTo avoid inadvertent damage, operators must wear rubber gloves, finger cots, or other suitablehand/finger covers and

19、exercise reasonable caution in handling the packet or condom in order to minimize the possibility ofdamage during the testing procedure.4.1.3 Process ControlsManufacturers may use process control tests to determine condom properties. Finished condoms shallbe used for qualification and referee tests.

20、4.1.4 LotA collection of condoms of the same design, color, shape, size, and formulation manufactured continuously, usingthe same process, raw materials, or the same specification, common equipment, and packaged with the same lubricant and anyother additives or dressing in the same type of individua

21、l container. The maximum lot size shall be 500 000 condoms.4.2 DimensionsCondoms shall meet the requirements listed in Table 2.4.2.1 Procedures for Dimensional Test:4.2.1.1 LengthMeasure the length of the condom to the nearest 1 mm, using the method described in Annex A1.4.2.1.2 WidthMeasure to the

22、nearest 0.5 mm the width of the condom laid flat at a distance 30 6 5 mm from the open end.4.2.1.3 ThicknessMeasure the thickness of condoms dried at room temperature for a minimum of 16 h after any dressingmaterials have been removed with water or isopropanol. Measure the wall thickness at three po

23、ints, 30 6 5 mm, 90 6 5 mm, and150 6 5 mm from the closed end.points per the table below. The thickness measuring device shall conform to that specified inPractice D3767, Test Method A with the pressure of the foot thickness gage at 22 6 5 kPa. When a condom is textured, measurethe thickness in the

24、nontextured area. Report the measurements to the nearest 0.01 mm.Condom Length (mm) Thickness Measurement Pointsfrom Closed End (5 mm)125 135 20, 60, 100136 160 25, 75, 125160+ 30, 90, 1504.3 Tensile PropertiesThis part of the specification specifies a method for determining the breaking force, tens

25、ile strength, andultimate elongation of rubber contraceptives. There are no breaking force, tensile strength, or elongation requirements for condomsgiven in this specification.4.3.1 Procedures for Tensile PropertiesBreaking force, tensile strength, and ultimate elongation. Test methods are presented

26、in Appendix X1 and Test Methods D412.4.3.1.1 As IsCondoms that are less than 12 months old and have not been subjected to accelerated aging.4.3.1.2 Accelerated AgingHeat condoms to be aged in their primary packages at 70 6 2C for 166 6 2 h in accordance withTest Method D573. Determine tensile proper

27、ties not less than 16 h or not more than 96 h after heating. Manufacturers may useprocess control tests to determine suitable shelf life, but accelerated aging at 70C for 166 h shall be used for qualification testsand referee tests.4.4 Air Burst PropertiesCondoms shall conform to the requirements of

28、 4.4.1 for pressure and 4.4.2 for volume.4.4.1 PressureWhen tested as described in Annex A2, the bursting pressure shall not be less than 1.0 kPa.4.4.2 VolumeWhen tested as described in Annex A2, the bursting volume shall not be less than that as calculated by thefollowing equation:TABLE 1 Quality I

29、nspection RequirementsACharacteristic Inspection Level AQLCondomDimensions S-2 4.0Air burst properties I 1.5Leakage I 0.25PackagePackage integrity S-3 2.5A ANSI MIL-STD 105E.D3492 162Vmin50.00592w 2! (1)Vmin50.00003947W2L (1)where:Vmin = minimum burst volume in dm3, rounded to the nearest 1 dm3, and

30、w = nominal flat width in millimetres of the shank portion of the condom measured 70 6 5 mm from the open end.Vmin = minimum burst volume in dm3, rounded to the nearest 1 dm3,W = nominal flat width in millimetres of the shank portion of the condom measured 70 6 5 mm from the open end, andL = inflati

31、on length of the condom in millimetres.NOTE 4Cubic decimetre (dm3) is equivalent to litre (L).NOTE 5If the length of the condom is 125 to 135 mm, then the inflation length is 100 mm. If the length of the condom is 136 to 160 mm, then theinflation length is 125 mm. If the length of the condom is 161

32、to 210 mm, then the inflation length is 150 mm.4.5 Leakage:4.5.1 CriteriaCondoms that burst during the test or show any evidence of leakage in the test area, including seepage,microdroplets, squirters, etc., not including leakage at a distance of 25 mm (1 in.) or less from the open end, will be cons

33、ideredfailures.4.5.2 The “Hang-and-Squeeze” test method described in AnnexA3 is recommended; however, when the purchaser specifies bythe contract or purchase order, the “Hang-and-Roll” test method described in ISO 4074 may be used by the manufacturer in placeof the method described in Annex A3.5. Pa

34、ckaging5.1 Unless otherwise specified, packaging shall be in accordance with the manufacturers commercial practice.5.2 Condom packages shall be tested in accordance with Test Method D3078 with the pressure reduced at least 50.8 kPa (15in. of Hg) below atmospheric pressure. The inspection requirement

35、s of Section 10.2 of Test Method D3078 are not required.Package integrity requirements are stated in Table 1.6. Labeling6.1 Each condom package (individual primary package and retail package) shall be marked legibly.6.1.1 Each condom package (individual primary package and retail package) shall incl

36、ude the name or trademark of the product.6.1.2 Each condom package (individual and retail) shall include the statement, “Caution: This Product Contains Natural RubberLatex Which May Cause Allergic Reactions.”6.2 The condom primary package (a.k.a. “wrapper” or “foil”) and the retail package shall dis

37、play the expiration date, whichshall be marked as such, for example, “Exp.”6.2.1 The expiration date, which shall be interpreted as the last day of the month indicated, shall be displayed as the month andyear of expiry using either a numeric or alphabetic month, preceded or followed by the numeric y

38、ear designation, for example:01/2010 or Jan 2010 or 2010/01 or 2010 Jan.6.2.2 The expiration date shall be determined as specified in Annex A4.6.2.3 Each condom package shall also include the name and place of business of manufacturer, packer, or distributor; statementof identity (“latex condom”); l

39、ot number and expiration date; and, if appropriate, country of origin (for example, “Made in _”).6.3 The retail package label shall include the intended uses, appropriate warning statements, and declaration of net quantity ofcontents.TABLE 2 Dimensional RequirementsNominal Length(mm)A,BNominal FlatW

40、idth (mm)C,DThickness(mm)Minimum 170 47 0.03Maximum 210 57 N/ATABLE 2 Dimensional RequirementsNominal Length(mm)A,BNominal FlatWidth (mm)C,DThickness(mm)Minimum 125 45 0.03Maximum 210 60 N/AA The length of the condom shall be measured excluding the reservoir tip if any.B No length measurement shall

41、deviate from the nominal length stated by themanufacturer by more than 10 mm.C No width measurement shall deviate from the nominal width stated by themanufacturer by more than 2 mm.D For condoms having a shaped profile about the closed end, the width of theprofile, when laid flat, shall be not more

42、than 75 mm.D3492 1636.3.1 The retail package label may also contain information regarding the description of the condom (for example, nominalwidth, length, texture, shape, etc.).6.3.2 Appropriate directions for use shall be included on the retail package or separately in a package insert.6.3.3 For p

43、ackaged condoms intended for export from the USA, each condom package (individual and retail) shall accord tothe specifications of the foreign purchaser and not be in conflict with the laws of the country to which it is intended for export.Locallabeling requirements take precedence over the labeling

44、 requirements listed in the standard but are not a part of the standard.6.3.3.1 For packaged condoms intended for sale within the USA, each condom package (individual and retail) shall accord tothe specifications set forth by the USFDA.6.3.3.2 For packaged condoms intended for export from the USA, e

45、ach condom package (individual and retail) shall accord tothe specifications of the foreign purchaser and not be in conflict with the laws of the country to which it is intended for export.7. Storage7.1 During production, processing, and packaging, condoms shall not be allowed to come into contact w

46、ith oil-based antiseptics,phenols and their derivatives, petroleum-based products, or other material harmful to rubber.7.2 In-process bulk unpackaged latex condoms should be stored in appropriate closed containers in dry areas at a temperaturebelow 40C (104F). Storage for short periods of time above

47、 this temperature will not be harmful to product. They should be keptaway from direct sources of heat and ultraviolet light.8. Quality Assurance8.1 When specified in the contract or purchase order, the supplier is responsible for the performance of all inspectionrequirements.9. Keywords9.1 condoms;

48、contraceptives; prophylactic; rubberANNEXES(Mandatory Information)A1. DETERMINATION OF LENGTHA1.1 PurposeA1.1.1 Annex A1 specifies a method of determining the length of rubber condoms.A1.2 PrincipleA1.2.1 Free hanging of the unrolled condom over a graduated mandrel (Fig.A1.1) and observation of its

49、length, the teat excluded.A1.3 EquipmentA1.3.1 A mandrel with a scale divided into millimetres and having the dimensions shown in Fig. A1.1.A1.4 ProcedureA1.4.1 Unroll the condom and smooth out the wrinkles resulting from the condom having been rolled up.A1.4.2 Put the condom over the mandrel and let it hang freely, stretched only by its own mass.A1.4.3 Note, to the nearest millimetre, the length of the condom as indicated on the scale outside the open end of the condom.D3492 164A1.5 Test ReportA1.5.1 Report the following informat