ASTM D7661-2018 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.pdf

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1、Designation: D7661 10 (Reapproved 2017)D7661 18Standard Test Method forDetermining Compatibility of Personal Lubricants withNatural Rubber Latex Condoms1This standard is issued under the fixed designation D7661; the number immediately following the designation indicates the year oforiginal adoption

2、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 test method covers procedures used to detect a shift in physical propert

3、ies of non-lubricated natural rubber latex (NRL)condoms after immersion in a personal lubricant. “Personal lubricants” are lubricants such as liquids or gels that are applied bythe consumer at the time of condom use.1.2 This test method does not attempt to address compatibility of lubricants applied

4、 to a condom at the time of manufacture(“manufacturer lubricants”). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life)of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply.1.3

5、 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appr

6、opriate safety, health, and environmental practices and determine the applicability ofregulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Develop

7、ment of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D3492 Specification for Rubber Contraceptives (Male Condoms)E177 Practice for Use of the Terms Precision and Bias i

8、n ASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method3. Summary of Test Method3.1 This test method measures the change in tensile and airburst properties, specifically force at break, percent elongation atbreak, airburst pressure, and ai

9、rburst volume, of non-lubricated NRL condoms and condom rings after 60 min of immersion in aliquid or gel lubricant. Condoms (up to the open end) and rings cut from condoms are immersed in personal lubricant, heated tobody temperature, cleaned of excess lubricant, and tested for both tensile and air

10、burst properties. Those properties are thencompared to control condoms and rings that are subjected to the same procedures without adding lubricant. For comparisonpurposes, baseline testing is also performed on condoms directly from their packages. A final group exposed to mineral oil is alsoinclude

11、d to validate the laboratorys test technique.3.2 A flow chart of the lubricant compatibility tensile test component is shown in Fig. 1. A flow chart of the lubricantcompatibility airburst test component is shown in Fig. 2. Each step of the process shall be performed immediately after theconclusion o

12、f the previous step.1 This test method is under the jurisdiction of ASTM Committee D11 on Rubber and Rubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved Oct. 1, 2017Sept. 1, 2018. Published December 2017December 2018. Orig

13、inally approved in 2010. Last previous edition approved in 20102017as D7661 10.D7661 10 (2017). DOI: 10.1520/D7661-10R17.10.1520/D7661-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume i

14、nformation, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard 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 adequatel

15、y depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases 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,

16、PA 19428-2959. United States1FIG. 1 Flow Chart for the Tensile Test Component of the Lubricant Compatibility TestD7661 182FIG. 2 Flow Chart for the Airburst Test Component of the Lubricant Compatibility TestD7661 1834. Significance and Use4.1 Weakening of natural rubber latex is known to occur after

17、 contact with certain lubricants, particularly petroleum-basedproducts.3,4 This procedure was developed as a screening method for lubricant manufacturers to determine whether or not aparticular personal lubricant has a significant effect on the tensile and airburst properties of an NRL condom.4.2 Th

18、is test method is designed for use on NRL condoms that meet the criteria of Specification D3492 and can: (1) have a ringspecimen cut in compliance with Appendix X1 of Specification D3492 and (2) be tested for burst properties in compliance withAnnex A2 of Specification D3492.4.3 This test method is

19、not to be used to determine the safety of either the test lubricant or NRL condom. This test method isto be used only to determine if the tensile or airburst properties of the NRL condom have been significantly affected by the testlubricant.5. Apparatus5.1 Environmental chamber or oven, capable of m

20、aintaining 40 6 2C.5.2 Airburst tester and clamping mount, capable of inflating a condom as specified in Annex A2 of Specification D3492.5.3 Tensile tester and roller grips, capable of testing ring specimens according to Appendix X1 of Specification D3492.5.4 Ring-cutting die, mechanical press, and

21、replaceable cutting surface, for cutting ring specimens from condoms, compliantwith Appendix XI of Specification D3492.6. Materials6.1 Test lubricant, for which compatibility with NRL condoms is unknown.6.2 Mineral oil, meeting the current requirements of the U.S. Pharmacopeia. The mineral oil is ex

22、pected to cause significantdegradation in the NRL condom physical properties when the test method is properly performed.6.3 Solvents, including water, isopropyl alcohol (IPA), and mild detergent, for cleaning laboratory equipment and supplies aftereach lubricant group has been tested.6.4 Cornstarch,

23、 to assist in dimensional measurements and tensile testing (optional).6.5 Shallow dishes with tight-fitting lids, in number sufficient to hold 20 condom rings and 20 whole condoms.6.6 Low-lint laboratory-grade paper towels, for removing lubricant from test samples after oven conditioning.6.7 General

24、 laboratory supplies, including beakers, graduated cylinder, plastic wrap, rubber bands, foam-tipped swabs, stirrods, plastic food-storage bags, ruler, powder-free exam gloves, Petri dishes, felt-tipped permanent marking pen, and cellophanetape.7. Sampling Overview, Sample Groups, and Sample Size7.1

25、 Sampling Overview:7.1.1 This test method shall be performed on three distinct brands of commercially available NRL condoms.7.1.2 Each brand of condom should be non-lubricated, straight-walled, smooth condoms from a single finished lot.7.1.2.1 If non-lubricated condoms are not available, condoms tha

26、t are lubricated with silicone lubricant may be used in theirplace.7.1.3 All condoms shall meet the requirements of Specification D3492.7.2 Sample Groups:7.2.1 Each of the three distinct brands of condoms shall be divided into four groups and tested for both tensile and airburstproperties in the fol

27、lowing order:7.2.1.1 Baseline GroupCondoms are tested directly from the package for tensile properties as per 9.610.6 and for airburstproperties as per 10.611.6.7.2.1.2 Control GroupCondoms are tested as per 9.210.2 9.610.6 and 10.211.2 10.611.6. In other words, the lubricantpreheat cycle (9.110.1 a

28、nd 10.111.1) is unnecessary and the rings/condoms are placed in an empty dish (no lubricant) forconditioning in the oven.All other handling of the control rings/condoms should be exactly the same as for the test lubricant group(for example, covering with plastic wrap, conditioning in the oven, slidi

29、ng fingers down rings/condoms to simulate removal ofexcess lubricant, blotting with low-lint tissue wipes, and so forth). There is no contact with lubricant in the control group.3 White N, Taylor K, LyszkowskiA, Tullett J, and Morris C., N., Taylor, K., Lyszkowski,A., Tullett, J., and Morris, C., Da

30、ngers of lubricants used with condoms.condoms,Nature., 1988, Sep 1;335(6185):19.4 Voeller B, Coulson A, Bernstein G, and Nakamura R, B., Coulson, A., Bernstein, G., and Nakamura, R., Mineral oil lubricants cause rapid deterioration of latexcondoms., Contraception., 1989, Jan;39(1):95-102.D7661 1847.

31、2.1.3 Test Lubricant GroupCondoms are tested as per Sections 910 and 1011 with a lubricant for which condomcompatibility is unknown.7.2.1.4 Mineral Oil GroupCondoms are tested as per Sections 910 and 1011 with mineral oil, which is known to adverselyaffect the physical properties of NRL condoms. If

32、this test method is properly conducted, significant degradation in airburst andtensile properties should be observed in this group.7.3 Sample SizeThe sample size for tensile testing shall be no fewer than 20 condoms per group. The sample size for airbursttesting shall be no fewer than 20 condoms per

33、 group.Asample size of 20 per group is adequately powered to detect a 10 % changein airburst pressure, airburst volume, and percent elongation, as well as a 25 % change in force at break.8. Cross-Contamination8.1 It is important to test the four treatment groups in the order prescribed (beginning wi

34、th baseline, then controls, then the testlubricant, and finally, the mineral oil) so as to reduce the possibility of cross-contamination of lubricants, especially mineral oil.8.2 It is recommended that separate laboratory supplies (dishes, utensils, and so forth) be used for each lubricant group unl

35、essa thorough scrubbing of all reusable laboratory supplies is conducted using detergent and water.8.3 It is expected that all laboratory equipment (including airburst and tensile equipment, as well as laboratory equipmenthandles, keypads, ruler, thickness gage, and so forth) will undergo a thorough

36、 cleaning using IPA and low-lint wipes after testingeach lubricant group. Gloves shall also be changed between testing each lubricant group.9. Sample Preparation Lubricant Removal9.1 As described in 7.1.2.1, if non-lubricated condoms are not available, lubricated condoms may be used in their place.L

37、ubricant should be removed from the outside of the condoms in the control, test lubricant, and mineral oil groups beforebeginning sample preparation (10.1 and 11.1). Lubricant should not be removed from condoms in the baseline group.9.2 Remove lubricant using the blotting method outlined in 10.5. St

38、art with 10.5.1 and end with 10.5.14 while skipping the stepsdescribed in 10.5.410.5.7.10. Procedure for Tensile TestingNOTE 1Powder-free exam gloves should be worn during each step of the procedure.10.1 Lubricant Preheat Cycle:10.1.1 Determine the volume of lubricant necessary to yield a depth of 5

39、 6 0.5 mm in the shallow dish (this may be done usingwater and a ruler).NOTE 2A 225- by 225-mm dish requires approximately 250 mL of lubricant to yield a depth of 5 mm.10.1.2 Measure and dispense the volume of lubricant determined in 9.1.110.1.1 into a glass beaker, and then transfer half of thisvol

40、ume into the shallow dish. If necessary, tilt the dish from side to side to spread the lubricant evenly across the bottom of thedish.NOTE 3For high-viscosity lubricants, it may be necessary to use a foam-tipped swab or other clean utensil to spread the lubricant across the bottomof the dish. Small a

41、reas lacking coverage are permissible, as the lubricant will continue to spread during preheating.10.1.3 Cover the shallow dish with a tight-fitting lid to prevent evaporation during preheating.10.1.4 Cover the beaker containing the remaining half of lubricant with plastic wrap and a rubber band.10.

42、1.5 The covered dish and beaker of lubricant shall be preheated for a minimum of 2 h in an environmental chamber or ovenmaintained at 40 6 2C. Record the actual length of time that the dish and beaker are in the chamber/oven.10.2 Ring Specimens:10.2.1 During the lubricant preheat cycle (9.110.1), ra

43、ndomly select a minimum of 20 non-lubricated NRL condoms from asingle finished lot of one brand for tensile testing.10.2.2 Prepare one ring specimen from each condom as per Appendix X1 in Specification D3492.NOTE 4This procedure is intended for non-lubricated smooth NRL condoms; therefore sections X

44、1.4.1.3 through X1.4.1.8 in Appendix X1 ofSpecification D3492 are not applicable.10.3 Lubricant Application:10.3.1 At the conclusion of the lubricant preheat cycle (9.110.1), remove the lubricant from the oven. Uncover the dish andbeaker of preheated lubricant.10.3.2 Immediately lay all rings in the

45、 preheated dish of lubricant. Rings should lay flat. Leave sufficient space between rings(5 to 10 mm) in case swelling occurs, for example, with petroleum-based lubricants.10.3.3 Dispense lubricant from the preheated beaker directly on top of rings so as to completely immerse the rings in lubricant.

46、Use a foam-tipped swab or other utensil to transfer any remaining lubricant from the walls of the beaker to the dish of rings.NOTE 5For high-viscosity lubricants, it may be helpful to transfer the preheated lubricant from the beaker into a plastic food storage bag. Cut a holein one corner of the bag

47、 and squeeze out the lubricant onto the rings. The lubricant will spread during heating; therefore, only minimal spreading of theD7661 185lubricant across the rings, with a foam-tipped swab or other clean utensil, is necessary.10.3.4 Using a foam-tipped swab (or glass stir rod) and gentle pressure,

48、briefly attempt to remove any large air bubbles trappedwithin the rings or lubricant or both. If the bubbles do not easily remove, leave them there.10.3.5 Cover the dish of rings with plastic wrap in the following manner: position plastic wrap over the dish and let it fall ontothe lubricant inside t

49、he dish. Avoid the formation of air bubbles by slowly smoothing the plastic wrap from the center of the dishto all four walls. Drape the excess plastic wrap over the walls of the dish. The plastic wrap should be in full contact with thelubricant all the way to the walls of the dish so as to create an even lubricant layer over the rings during conditioning. See Fig.3. Note how the fingers tuck the plastic wrap to the edges and corners of the dish.10.4 Ring ConditioningImmediately condition the dish of rings for 60 6 5 min in an environmental chamber or