ASTM D7661-2010 5000 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms《测定人体滑润剂与天然橡胶避孕套亲和性的标准试验方法》.pdf

《ASTM D7661-2010 5000 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms《测定人体滑润剂与天然橡胶避孕套亲和性的标准试验方法》.pdf》由会员分享，可在线阅读，更多相关《ASTM D7661-2010 5000 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms《测定人体滑润剂与天然橡胶避孕套亲和性的标准试验方法》.pdf（14页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: D7661 10Standard 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 the case of revisio

2、n, 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 non-lubricated natur

3、al 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 condom at the time of

4、manufacture (“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 values stated in SI

5、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 safety and health p

6、ractices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D3492 Specification for Rubber Contraceptives (Male Con-doms)E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlabor

7、atory 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 airburst volume, ofnon-lubricated NRL condoms and condom rings

8、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 airburstproperties. Those properties are then compared to controlco

9、ndoms 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 validate the laboratorys test technique.3.2 A flow chart of th

10、e 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 previous step.4. Significance and Use4.1 Weakening of natural r

11、ubber 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 lubricant has a significant effect on thetensile and airburst pr

12、operties 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 ofSpecification D3492 and (2) be tested for burst properties incompliance with Annex A2 of Specification

13、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 significantly affected by the testlubricant.5. Apparatus5.1 Environmental c

14、hamber or oven, capable of maintaining40 6 2C.1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40.01 on Condoms TG.Current edition approved Oct. 1, 2010. Published November 2010. DOI:10.1520/D7661-10.2For referenced ASTM

15、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 C. Dangers oflubricants us

16、ed 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):95-102.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-

17、2959, United States.FIG. 1 Flow Chart for the Tensile Test Component of the Lubricant Compatibility TestD7661 102FIG. 2 Flow Chart for the Airburst Test Component of the Lubricant Compatibility TestD7661 1035.2 Airburst tester and clamping mount, capable of inflatinga condom as specified in Annex A2

18、 of Specification D3492.5.3 Tensile tester and roller grips, capable of testing ringspecimens 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 D3

19、492.6. Materials6.1 Test lubricant, for which compatibility with NRL con-doms is unknown.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 perfor

20、med.6.3 Solvents, including water, isopropyl alcohol (IPA), andmild detergent, for cleaning 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 n

21、umber suffi-cient to hold 20 condom rings and 20 whole condoms.6.6 Low-lint laboratory-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,

22、 plastic food-storage bags, ruler, powder-free examgloves, Petri dishes, felt-tipped 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 con

23、doms.7.1.2 Each brand of condom should be non-lubricated,straight-walled, smooth condoms 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 f

24、or both tensile and airburstproperties in the following order:7.2.1.1 Baseline GroupCondoms 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

25、preheat cycle (9.1and 10.1) is unnecessary and the rings/condoms are placed inan empty 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 t

26、he oven, sliding fingersdown rings/condoms to simulate removal of excess lubricant,blotting 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 compa

27、t-ibility is unknown.7.2.1.4 Mineral Oil GroupCondoms are tested as perSections 9 and 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

28、in thisgroup.7.3 Sample SizeThe sample size for tensile testing shallbe no fewer than 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

29、, andpercent 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 theorder prescribed (beginning with baseline, then controls, thenthe test lubricant, and finally, the mineral oil) so as to reducethe possibility of cros

30、s-contamination of lubricants, especiallymineral oil.8.2 It is recommended that separate 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 a

31、ll laboratory equipment (includingairburst and tensile equipment, as well as laboratory 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 lubr

32、icant group.9. Procedure for Tensile TestingNOTE 1Powder-free exam gloves should be worn 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

33、225- by 225-mm dish requires approximately 250 mL oflubricant to yield a depth of 5 mm.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 thisvolume into the shallow dish. If necessary, tilt the dish fromside to side to spread the l

34、ubricant evenly across the bottom ofthe dish.NOTE 3For high-viscosity 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 pre

35、heating.9.1.3 Cover the shallow dish with a tight-fitting lid toprevent 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 of 2 h in an envir

36、onmental chamberor oven maintained at 40 6 2C. Record the actual length oftime that the dish and beaker are in the chamber/oven.9.2 Ring Specimens:D7661 1049.2.1 During the lubricant preheat cycle (9.1), randomlyselect a minimum of 20 non-lubricated NRL condoms from asingle finished lot of one brand

37、 for tensile testing.9.2.2 Prepare one ring specimen from each condom as perAppendix 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 Appl

38、ication:9.3.1 At the conclusion of the lubricant preheat cycle (9.1),remove the 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 cas

39、e swelling occurs, for example, withpetroleum-based lubricants.9.3.3 Dispense lubricant 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

40、dishof rings.NOTE 5For high-viscosity lubricants, it may be helpful to transfer 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 sp

41、read-ing of the lubricant across the rings, with a foam-tipped swab or otherclean 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 rem

42、ove, leave them there.9.3.5 Cover the dish of rings with plastic wrap in thefollowing 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. Dr

43、ape the excess plasticwrap over the walls of the dish. The plastic wrap should be 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 co

44、rners of the dish.9.4 Ring ConditioningImmediately condition the dish ofrings for 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 oftw

45、o wipes will be called Blotting Paper #1.9.5.2 Repeat 9.5.1, yielding a second set 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 conditionin

46、g (9.4), removethe dish of rings from the oven and immediately remove theplastic 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 twofingers down the ri

47、ng 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 inrows on one half of Blotting Paper #1. R

48、ings should not contactone another.9.5.9 Fold Blotting Paper #1 over the rings. See Fig. 5.9.5.10 Blot excess lubricant from the rings as follows: placehands in the middle of Blotting Paper #1. Exert gentle pressurewhile sliding hands from the center of the folded wipes to theedges, doing so three t

49、imes (so that each ring is pressed threetimes with the same blotting paper). See Fig. 6.FIG. 3 Tuck Plastic Wrap Inside DishD7661 1059.5.11 Pick up each ring from Blotting Paper #1 and layonto one half of Blotting Paper #2. Rings should be laid inrows, but should not contact one another.9.5.12 Fold Blotting Paper #2 over the rings.9.5.13 Place hands in the middle of Blotting Paper #2. Exertgentle pressure while sliding hands from the center of the paperto the edges, doing so three times (so that each ring is pressedthree times with the same blotting paper).9.5.14