ASTM D7661-10(2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.pdf

1、Designation: D7661 10 (Reapproved 2017)Standard 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 or, in t

2、he 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 shiftin physical properties of no

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

4、dom at the time ofmanufacture (“manufacturer lubricants”). It shall be the re-sponsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that ispackaged within the individual condom wrapper. Other regu-latory requirements may apply.1.3 The va

5、lues stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate s

6、afety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment

7、of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D3492 Specification for Rubber Contraceptives (Male Con-doms)E177 Practice for Use of the Terms Precision and Bias inAS

8、TM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3. Summary of Test Method3.1 This test method measures the change in tensile andairburst properties, specifically force at break, percent elonga-tion at break, airburst pressure, and airbur

9、st volume, ofnon-lubricated NRL condoms and condom rings after 60 minof immersion in a liquid or gel lubricant. Condoms (up to theopen end) and rings cut from condoms are immersed inpersonal lubricant, heated to body temperature, cleaned ofexcess lubricant, and tested for both tensile and airburstpr

10、operties. Those properties are then compared to controlcondoms and rings that are subjected to the same procedureswithout adding lubricant. For comparison purposes, baselinetesting is also performed on condoms directly from theirpackages. A final group exposed to mineral oil is also includedto valid

11、ate the laboratorys test technique.3.2 A flow chart of the lubricant compatibility tensile testcomponent is shown in Fig. 1. A flow chart of the lubricantcompatibility airburst test component is shown in Fig. 2. Eachstep of the process shall be performed immediately after theconclusion of the previo

12、us step.4. Significance and Use4.1 Weakening of natural rubber latex is known to occurafter contact with certain lubricants, particularly petroleum-based products.3,4This procedure was developed as a screeningmethod for lubricant manufacturers to determine whether ornot a particular personal lubrica

13、nt has a significant effect on thetensile and airburst properties of an NRL condom.4.2 This test method is designed for use on NRL condomsthat meet the criteria of Specification D3492 and can: (1) havea ring specimen cut in compliance with Appendix X1 of1This test method is under the jurisdiction of

14、 ASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Oct. 1, 2017. Published December 2017. Originallyapproved in 2010. Last previous edition approved in 2010 as D7661 10. DOI:10.1520/D7661-

15、10R17.2For 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 standards Document Summary page onthe ASTM website.3White N, Taylor K, Lyszkowski A, Tullett J, and Morris

16、 C. Dangers oflubricants used with condoms. Nature. 1988 Sep 1;335(6185):19.4Voeller B, Coulson A, Bernstein G, and Nakamura R, Mineral oil lubricantscause rapid deterioration of latex condoms. Contraception. 1989 Jan;39( 1):95-102.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We

17、st Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World T

18、rade Organization Technical Barriers to Trade (TBT) Committee.136 FIG. 1 Flow Chart for the Tensile Test Component of the Lubricant Compatibility TestD7661 10 (2017)236 FIG. 2 Flow Chart for the Airburst Test Component of the Lubricant Compatibility TestD7661 10 (2017)336 Specification D3492 and (2)

19、 be tested for burst properties incompliance with Annex A2 of Specification D3492.4.3 This test method is not to be used to determine the safetyof either the test lubricant or NRL condom. This test method isto be used only to determine if the tensile or airburst propertiesof the NRL condom have been

20、 significantly affected by the testlubricant.5. Apparatus5.1 Environmental chamber or oven, capable of maintaining40 6 2C.5.2 Airburst tester and clamping mount, capable of inflatinga condom as specified in Annex A2 of Specification D3492.5.3 Tensile tester and roller grips, capable of testing rings

21、pecimens according to Appendix X1 of Specification D3492.5.4 Ring-cutting die, mechanical press, and replaceablecutting surface, for cutting ring specimens from condoms,compliant with Appendix XI of Specification D3492.6. Materials6.1 Test lubricant, for which compatibility with NRL con-doms is unkn

22、own.6.2 Mineral oil, meeting the current requirements of theU.S. Pharmacopeia. The mineral oil is expected to causesignificant degradation in the NRL condom physical propertieswhen the test method is properly performed.6.3 Solvents, including water, isopropyl alcohol (IPA), andmild detergent, for cl

23、eaning laboratory equipment and suppliesafter each lubricant group has been tested.6.4 Cornstarch, to assist in dimensional measurements andtensile testing (optional).6.5 Shallow dishes with tight-fitting lids, in number suffi-cient to hold 20 condom rings and 20 whole condoms.6.6 Low-lint laborator

24、y-grade paper towels, for removinglubricant from test samples after oven conditioning.6.7 General laboratory supplies, including beakers, gradu-ated cylinder, plastic wrap, rubber bands, foam-tipped swabs,stir rods, plastic food-storage bags, ruler, powder-free examgloves, Petri dishes, felt-tipped

25、permanent marking pen, andcellophane tape.7. Sampling Overview, Sample Groups, and Sample Size7.1 Sampling Overview:7.1.1 This test method shall be performed on three distinctbrands of commercially available NRL condoms.7.1.2 Each brand of condom should be non-lubricated,straight-walled, smooth cond

26、oms from a single finished lot.7.1.3 All condoms shall meet the requirements of Specifi-cation D3492.7.2 Sample Groups:7.2.1 Each of the three distinct brands of condoms shall bedivided into four groups and tested for both tensile and airburstproperties in the following order:7.2.1.1 Baseline GroupC

27、ondoms are tested directly fromthe package for tensile properties as per 9.6 and for airburstproperties as per 10.6.7.2.1.2 Control GroupCondoms are tested as per 9.2 9.6and 10.2 10.6. In other words, the lubricant preheat cycle (9.1and 10.1) is unnecessary and the rings/condoms are placed inan empt

28、y dish (no lubricant) for conditioning in the oven. Allother handling of the control rings/condoms should be exactlythe same as for the test lubricant group (for example, coveringwith plastic wrap, conditioning in the oven, sliding fingersdown rings/condoms to simulate removal of excess lubricant,bl

29、otting with low-lint tissue wipes, and so forth). There is nocontact with lubricant in the control group.7.2.1.3 Test Lubricant GroupCondoms are tested as perSections 9 and 10 with a lubricant for which condom compat-ibility is unknown.7.2.1.4 Mineral Oil GroupCondoms are tested as perSections 9 and

30、 10 with mineral oil, which is known toadversely affect the physical properties of NRL condoms. Ifthis test method is properly conducted, significant degradationin airburst and tensile properties should be observed in thisgroup.7.3 Sample SizeThe sample size for tensile testing shall beno fewer than

31、 20 condoms per group. The sample size forairburst testing shall be no fewer than 20 condoms per group.A sample size of 20 per group is adequately powered to detecta 10 % change in airburst pressure, airburst volume, andpercent elongation, as well as a 25 % change in force at break.8. Cross-Contamin

32、ation8.1 It is important to test the four treatment groups in theorder prescribed (beginning with baseline, then controls, thenthe test lubricant, and finally, the mineral oil) so as to reducethe possibility of cross-contamination of lubricants, especiallymineral oil.8.2 It is recommended that separ

33、ate laboratory supplies(dishes, utensils, and so forth) be used for each lubricant groupunless a thorough scrubbing of all reusable laboratory suppliesis conducted using detergent and water.8.3 It is expected that all laboratory equipment (includingairburst and tensile equipment, as well as laborato

34、ry equipmenthandles, keypads, ruler, thickness gage, and so forth) willundergo a thorough cleaning using IPAand low-lint wipes aftertesting each lubricant group. Gloves shall also be changedbetween testing each lubricant group.9. Procedure for Tensile TestingNOTE 1Powder-free exam gloves should be w

35、orn during each step ofthe procedure.9.1 Lubricant Preheat Cycle:9.1.1 Determine the volume of lubricant necessary to yielda depth of 5 6 0.5 mm in the shallow dish (this may be doneusing water and a ruler).NOTE 2A 225- by 225-mm dish requires approximately 250 mL oflubricant to yield a depth of 5 m

36、m.9.1.2 Measure and dispense the volume of lubricant deter-mined in 9.1.1 into a glass beaker, and then transfer half of thisD7661 10 (2017)436 volume into the shallow dish. If necessary, tilt the dish fromside to side to spread the lubricant evenly across the bottom ofthe dish.NOTE 3For high-viscos

37、ity lubricants, it may be necessary to use afoam-tipped swab or other clean utensil to spread the lubricant across thebottom of the dish. Small areas lacking coverage are permissible, as thelubricant will continue to spread during preheating.9.1.3 Cover the shallow dish with a tight-fitting lid topr

38、event evaporation during preheating.9.1.4 Cover the beaker containing the remaining half oflubricant with plastic wrap and a rubber band.9.1.5 The covered dish and beaker of lubricant shall bepreheated for a minimum of2hinanenvironmental chamberor oven maintained at 40 6 2C. Record the actual length

39、 oftime that the dish and beaker are in the chamber/oven.9.2 Ring Specimens:9.2.1 During the lubricant preheat cycle (9.1), randomlyselect a minimum of 20 non-lubricated NRL condoms from asingle finished lot of one brand for tensile testing.9.2.2 Prepare one ring specimen from each condom as perAppe

40、ndix X1 in Specification D3492.NOTE 4This procedure is intended for non-lubricated smooth NRLcondoms; therefore sections X1.4.1.3 through X1.4.1.8 inAppendix X1 ofSpecification D3492 are not applicable.9.3 Lubricant Application:9.3.1 At the conclusion of the lubricant preheat cycle (9.1),remove the

41、lubricant from the oven. Uncover the dish andbeaker of preheated lubricant.9.3.2 Immediately lay all rings in the preheated dish oflubricant. Rings should lay flat. Leave sufficient space betweenrings (5 to 10 mm) in case swelling occurs, for example, withpetroleum-based lubricants.9.3.3 Dispense lu

42、bricant from the preheated beaker directlyon top of rings so as to completely immerse the rings inlubricant. Use a foam-tipped swab or other utensil to transferany remaining lubricant from the walls of the beaker to the dishof rings.NOTE 5For high-viscosity lubricants, it may be helpful to transfer

43、thepreheated lubricant from the beaker into a plastic food storage bag. Cut ahole in one corner of the bag and squeeze out the lubricant onto the rings.The lubricant will spread during heating; therefore, only minimal spread-ing of the lubricant across the rings, with a foam-tipped swab or otherclea

44、n utensil, is necessary.9.3.4 Using a foam-tipped swab (or glass stir rod) and gentlepressure, briefly attempt to remove any large air bubblestrapped within the rings or lubricant or both. If the bubbles donot easily remove, leave them there.9.3.5 Cover the dish of rings with plastic wrap in thefoll

45、owing manner: position plastic wrap over the dish and let itfall onto the lubricant inside the dish. Avoid the formation ofair bubbles by slowly smoothing the plastic wrap from thecenter of the dish to all four walls. Drape the excess plasticwrap over the walls of the dish. The plastic wrap should b

46、e infull contact with the lubricant all the way to the walls of thedish so as to create an even lubricant layer over the rings duringconditioning. See Fig. 3. Note how the fingers tuck the plasticwrap to the edges and corners of the dish.9.4 Ring ConditioningImmediately condition the dish ofrings fo

47、r 60 6 5 min in an environmental chamber or ovenmaintained at 40 6 2C.9.5 Lubricant Removal:9.5.1 Lay one low-lint tissue wipe onto the bench top. Placea second low-lint tissue wipe on top of the first one. This set oftwo wipes will be called Blotting Paper #1.9.5.2 Repeat 9.5.1, yielding a second s

48、et of blotting paperadjacent to the first set (Blotting Paper #2).9.5.3 Repeat 9.5.1 again, yielding a third set of blottingpaper adjacent to the second set (Blotting Paper #3).9.5.4 At the conclusion of ring conditioning (9.4), removethe dish of rings from the oven and immediately remove theplastic

49、 wrap from the dish.9.5.5 Remove a preconditioned ring from the dish. Hold oneend of the ring with the non-dominant hand. Position the ringbetween two fingers of the dominant hand. Gently slide the twoFIG. 3 Tuck Plastic Wrap Inside DishD7661 10 (2017)536 fingers down the ring to remove excess lubricant.Avoid pullingor stretching the ring. See Fig. 4.9.5.6 Flip ring upside down and repeat the gentle sliding offingers down the ring.9.5.7 Lay the ring onto Blotting Paper #1.9.5.8 Repeat 9.5.5 9.5.7 for all rings, laying them out inro