ASTM F2392-2004(2010) Standard Test Method for Burst Strength of Surgical Sealants《外科用密封剂爆炸强度的标准方法》.pdf

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1、Designation: F2392 04 (Reapproved 2010)Standard Test Method forBurst Strength of Surgical Sealants1This standard is issued under the fixed designation F2392; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision

2、. 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 provides a means for comparison of theburst or rupture strength of sealants on soft tissue. This testmethod can be

3、 used as a clinically relevant model for qualityassurance, development, and comparative testing of differentadhesives or adherends.1.2 This test method measures only burst strength or “co-hesive strength” of an adhesive/adherend system, and not theadhesive strength.1.3 The values stated in SI units

4、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 practic

5、es and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D907 Terminology of Adhesives2.2 American Association for Tissue Banks (AATB) Stan-dard:Standards for Tissue Banking33. Terminology3.1 DefinitionsMany terms in this test method are d

6、efinedin Terminology D907.3.2 Definitions:3.2.1 adhesive failurefailure of the sealant/substrate inter-face during burst testing.3.2.2 burst strengththe average pressure required to causefailure of the sealant, either by cohesive or adhesive mecha-nisms.3.2.3 cohesive failurefailure of the sealant d

7、uring bursttesting.3.2.4 cohesive strengththe internal strength of the sealant,sometimes referred to as the adhesive bulk strength.3.2.5 substrate failurefailure of the substrate during bursttesting.3.2.6 tissue sealanta surface coating to prevent leakage ofbody fluids.4. Significance and Use4.1 Mat

8、erials and devices that function at least in part byadhering to living tissues are finding increasing use in surgicalprocedures, either as adjuncts to sutures and staples or as frankreplacements for those devices in a wide variety of medicalprocedures. While the nature and magnitude of the forcesinv

9、olved varies greatly with indication and with patient specificcircumstances, all uses involve, to some extent, the ability ofthe material to resist imposed mechanical forces. Therefore, themechanical properties of the materials, and in particular theadhesive and cohesive properties, are important pa

10、rameters inevaluating their fitness for use. In addition, the mechanicalproperties of a given sealant composition can provide a usefulmeans of determining product consistency for quality control,or as a means for determining the effects of various surfacetreatments on the substrate prior to use of t

11、he device.4.2 The complexity and variety of individual applicationsfor sealant, even within a single indicated use (surgicalprocedure), is such that the results of a burst test are notsuitable for determining allowable design stresses withoutthorough analysis and understanding of the application and

12、sealant behaviors.4.3 This test method may be used for comparing sealants forsusceptibility to environmental changes, but such comparisonsmust be made with great caution since different sealants mayrespond differently to varying conditions.4.4 As the true sealant strength is strongly dependent on th

13、estrength of the sealant/substrate interface, the selection of aproper test substrate is critical. Care must be taken whenextrapolating in vitro test results to in vivo expectations. In1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and

14、is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Sept. 1, 2010. Published November 2010. Originallyapproved in 2004. Last previous edition approved in 2004 as F2392 04. DOI:10.1520/F2392-04R10.2For referenced ASTM standards, visit the ASTM website,

15、 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.3Available from American Association for Tissue Banks (AATB), 1320 OldChain Bridge Rd., Suite 450, McLean, VA 22101.

16、1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.vitro sealant optimization may not translate to expected in vivoperformance due to differences in substrate surface, strength,and elasticity.5. Apparatus5.1 Testing MachineA testing mac

17、hine for determiningthe sealant strength and system failure mechanism and com-prising essentially the following:5.1.1 Test FixtureA stationary fixture containing the testsubstrate and applied sealant. Fluid flows into the fixture at afixed rate, allowing for the pressurization of the sealed sub-stra

18、te.5.1.2 Positive Displacement Fluid PumpA pump provid-ing a constant flow of fluid to the test fixture. The pump mustbe capable of constant flow at pressures of interest. Syringepumps are particularly well suited for this type of testing sincethey do not cause pulsatile flow. Peristaltic pumps have

19、 alsobeen used successfully since the pump tubing tends to dampenpulsations.NOTE 1Saline is the typical fluid of choice. When air is used, areduction in pressurization rate is expected due to gas compressibility.5.1.3 Pressure gageConsisting of a gage and method ofcapturing peak pressures. System sa

20、mpling rate should beadequate to capture peak burst pressures. Sensitivity andprecision should result in less than 1 % error. The burst testsystem is shown in Fig. 1. The system (A) consists of a fluidpump, a test fixture, and pressure gage connected by rigidplastic tubing. The test fixture (B) cons

21、ists of a base, O-ring,and top.5.2 Temperature-controlling EquipmentMust be capableof maintaining the test temperature to 62C. If ambientlaboratory conditions are employed, the same degree of controlis required. A water bath or environmental chamber capable ofmaintaining 37C is required for testing

22、on tissue substrates.6. Test Substrate6.1 For Comparative TestingCollagen sausage casing,Nippi Casing Co. (#320), should be used. It is a collagen casingof consistent properties and thickness.NOTE 2Nippi sausage casing (#320) is widely available throughoutthe meat packing industry.6.2 Cut sections o

23、ff of the collagen casing roll, wash indeionized water (to remove glycerin), then soak in freshdeionized water for five minutes.6.3 Application Specific TestingSince the fixture mustclamp down on the substrate to prevent fluid leakage, sometissues (lung, liver, and so forth) may not be suitable for

24、thistest.6.3.1 The burst strength of any sealant is dependant on itsinternal cohesive strength, as well as the adhesive strength tothe test substrate, or adherend. For a specific application, thepreferred substrate is freshly harvested tissue from the targetorgan of a domestic food animal. Tissue fr

25、om bovine, porcine,or ovine origin is preferred due to wide availability and the factthat relatively large samples of tissue can be harvested from asingle source. Ideally, the tissue should be used within 24 h ofharvest and should be kept between 5 and 10C prior to testingif it cannot be used immedi

26、ately after harvesting. Storage andhandling of tissue samples should be carried out according tothe guidelines set forth in Standards for Tissue Banking by theAmerican Association of Tissue Banks. The specimens shouldbe brought to the test temperature or other prescribed tempera-ture (such as body t

27、emperature) prior to application of thesealant.6.3.2 Fixed tissue should not be used since it has beendemonstrated that fixatives cause large alterations in themechanical properties of the tissue and it is probable that theadhesive strength would be affected as well.6.3.3 If the target organ is of a

28、 size or geometry, or both, thatdoes not allow fabrication of test samples, a tissue of similarorigin but larger size should be used.6.3.4 The thickness of the tissue sample should be mini-mized and should not exceed 5 mm. Thicker samples will leadto distortion of the substrate and may leak in the t

29、est fixture.Also, thicker samples will lead to sealant adherence on theinsides of the hole itself, possibly leading to different failuremechanisms. It is also important that the thickness be asuniform as possible.6.4 Substrates for Quality Control Testing:6.4.1 For testing that is undertaken as part

30、 of a qualitycontrol process in the manufacturing of a tissue sealant, the useof freshly harvested tissue is highly inconvenient and may alsolead to unacceptable variation in the test results, especially ifthe failure occurs in the adherend (substrate failure). Since thepurpose of quality control te

31、sting is to demonstrate consistencyin the device, substitution of a model substrate is preferred solong as it is demonstrated that the sealant does bond to theadherend. Since the burst test failure mechanism can depend onthe amount of substrate deformation, attention to substrateflexibility and elas

32、ticity is important to best match in vivosubstrates.7. Substrate Preparation7.1 Cut substrate into circles (3.0 6 0.1 cm diameter) usinga sharp scalpel or stamp.7.2 Use a hole punch to create a 3.0 mm diameter hole in thecenter of the circular substrate.NOTE 3Depending on the application, different

33、hole sizes, cuts, orsuture lines may be used. Store in saline at room temperature until readyto use if testing will be done within1hofpreparation. Prepared substratemay be stored in saline in a refrigerator for up to 48 h.7.3 Number of Test SpecimensTest at least 10 specimensof each type. Burst test

34、ing tends to give high variances and willrequire more samples to attain a reasonable estimate of themean strength. The actual number of test samples tested willdepend on data variance.8. Sample Preparation8.1 Tissue Preparation:8.1.1 Place substrate on a polytetrafluoroethylene (PTFE)sheet and smoot

35、h out.8.1.2 Pat substrate using surgical gauze to remove excesswater.F2392 04 (2010)28.1.3 Place an approximately 1.0 mm thick PTFE mask ontop of the substrate, centering the 15 mm hole in the mask overthe hole in the substrate as shown in Fig. 2.8.2 Sealant Application:8.2.1 Assemble the applicator

36、 and prepare the tissue sealantas directed for the product being tested. Use appropriate tip.8.2.2 Apply the sealant per the instructions for use (IFU) inquantities sufficient to fill the hole in the PTFE mask. Recordthe volume of adhesive used.NOTE 4Thickness is a very important parameter to contro

37、l. Variablethickness will lead to greater burst strength variation.NOTE 5Low viscosity sealants may flow through the 3 mm hole andunder the substrate during this procedure. This may be prevented byplacing a thin layer of petroleum jelly between the PTFE and substrate.8.2.3 Allow the adhesive to cure

38、 per the IFU.8.2.4 Lightly run an aluminum spatula around the edges ofthe sample to release from the mold.8.2.5 Peel the substrate off the PTFE block, being carefulnot to tear the tear the tissue sealant.8.2.6 Samples tested more than 5 min after sealant applica-tion should be covered with gauze soa

39、ked in saline and storedat the conditioning temperature (see 9.1).9. Test Procedure9.1 Condition the test specimens for definite periods of timeunder specified, controlled conditions before testing if desired.FIG. 1 Burst Test System (A), with an Exploded View of the Assembled Test Fixture (B),and t

40、he Test Fixture Cross Sectional View (in.) (C)F2392 04 (2010)3Recommended conditions for tissue sealants intended forinternal applications are 37 6 1C in phosphate bufferedsaline. For quality control testing the recommended conditionsare 23 6 2C and 50 6 5 % relative humidity.9.2 After conditioning,

41、 it is recommended that all speci-mens be stabilized at the test temperature for 15 min beforetesting if the test temperature is different from the conditioningtemperature. Tissue samples must be kept moist throughout theprocess to prevent shrinkage due to drying. For comparativetesting the test con

42、ditions should be 23 6 2C and 50 6 5%relative humidity (see Appendix X1).9.3 Test Fixture Assembly:9.3.1 Open the purge valve and turn on the fluid pump, thuspriming the test fixture with saline to eliminate air from thefluid line.9.3.2 Turn off the pump, and then place the substrate withtissue seal

43、ant onto the fixture base, with the sealant facing up.Place the O-ring (22 mm ID) on top of the tissue, and securethe fixture top in place.9.4 Zero the pressure gage, and set to capture the peakpressure.9.5 Advance saline into the test fixture by turning the fluidpump on at a flow rate of 2 mL/min.

44、Close the purge valve afterflow is established and all air has been purged from the lines.9.6 Record the peak pressure, and the type of failure(cohesive, adhesive, or substrate) based on observation of theburst test.10. Calculation10.1 Calculate the average and standard deviation of burststrength fo

45、r each group of samples.11. Report11.1 Report the following:11.1.1 Complete identification of the sealant tested, includ-ing type, source, date manufactured, manufacturers codenumber, and lot number.11.1.2 Complete identification of the substrate used, itsthickness, and any method used to clean or p

46、repare the surfaceprior to bonding.11.1.3 Estimated amount of sealant applied.11.1.4 Method of sealant application.11.1.5 Ambient conditions at time of bonding (temperature,humidity, and so forth).11.1.6 Average thickness of the sealant.11.1.7 Conditioning of specimen after application and priorto t

47、esting.11.1.8 Maximum, minimum, mean, and standard deviationof the burst strength for the group of specimens.11.1.9 Number of specimens tested.11.1.10 Type of failure.11.1.11 Test temperature and humidity employed.12. Precision and Bias12.1 A precision and bias statement does not exist for thistest

48、method because round-robin testing has not yet beenperformed.13. Keywords13.1 adhesive strength; burst strength; cohesive strength;tissue sealantThickness = 1 6 0.5 mmFIG. 2 PTFE Mask for Adhesive ApplicationF2392 04 (2010)4APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 As with all mechanical t

49、esting, the temperature andhumidity can have a large effect on the results obtained usingthis procedure. Ideally, all of the testing will be carried out atthe intended use temperature (37C for internal applications),and at a constant relative humidity. However, the equipmentrequired for environmental control is not available in alllaboratories. Furthermore, attempting to test samples immedi-ately after removal from the conditioning bath would lead tounacceptable variation in sample temperature at the time offailure. Therefore it was decided to allow t