1、Designation: F2256 05 (Reapproved 2015)Standard Test Method forStrength Properties of Tissue Adhesives in T-Peel byTension Loading1This standard is issued under the fixed designation F2256; the number immediately following the designation indicates the year oforiginal adoption or, in the case of rev
2、ision, 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 is intended to provide a means forcomparison of the adhesive strengths of tissue a
3、dhesivesintended for use as surgical adhesives or sealants, or both, onsoft tissue. With the appropriate choice of substrate, it may alsobe used for purposes of quality control in the manufacture oftissue adhesive based medical devices.1.2 The values stated in SI units are to be regarded asstandard.
4、 No other units of measurement are included in thisstandard.1.3 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 practices and determine the applica-b
5、ility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D907 Terminology of AdhesivesE4 Practices for Force Verification of Testing Machines2.2 American Association of Tissue Banks Standards:3Standards for Tissue Banking3. Terminology3.1 DefinitionsMany terms in this
6、test method are definedin Terminology D907.3.2 Definitions:3.2.1 flexibleas used in this test method, indicates that theadherends shall have such dimensions and physical propertiesas to permit bending them through any angle up to 90 withoutbreaking or cracking.3.2.2 tissue adhesivefor the purposes o
7、f this test method,tissue adhesive is defined as a compound or system intendedfor use in closing wounds (surgical or traumatic) or for sealingagainst leakage of body fluids.3.2.3 tissue sealanta surface coating with adequate adhe-sive strength to prevent leakage of body fluids.3.2.4 T-peel strengtht
8、he average load per unit width ofbond line required to produce progressive separation of twobonded flexible adherends, under conditions designated in thismethod.4. Significance and Use4.1 Materials and devices that function at least in part byadhering to living tissues are finding increasing use in
9、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 forcesinvolved varies greatly with indication and with patient specificcircumstances, all uses involve to some extent
10、the ability of thematerial to resist imposed mechanical forces. Therefore, themechanical properties of the materials, and in particular theadhesive properties, are important parameters in evaluatingtheir fitness for use. In addition, the mechanical properties of agiven adhesive composition can provi
11、de a useful means ofdetermining product consistency for quality control, or as ameans for determining the effects of various surface treatmentson the substrate prior to use of the device.4.2 The complexity and variety of individual applicationsfor tissue adhesive devices, even within a single indica
12、ted use(surgical procedure) is such that the results of a T-Peel test arenot suitable for determining allowable design stresses withoutthorough analysis and understanding of the application andadhesive behaviors.4.3 This test method may be used for comparing adhesivesor bonding processes for suscept
13、ibility to fatigue and environ-mental changes, but such comparisons must be made with greatcaution since different adhesives may respond differently tovarying conditions.5. Apparatus5.1 Testing Machine, of the constant-rate-of-crosshead-movement type and comprising essentially the following:1This te
14、st method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved May 1, 2015. Published July 2015. Originally approvedin 2003. Last previous edition approved
15、in 2010 as F2256 05 (2010). DOI:10.1520/F2256-05R15.2For 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.3Availabl
16、e from the American Association of Tissue Banks (AATB), 1350Beverly Rd., Suite 220-A, McLean, VA 22101.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.1.1 Fixed Member, a fixed or essentially stationary mem-ber carrying one grip.5.1
17、.2 Movable Member, a movable member carrying asecond grip.5.1.3 Grips, for holding the test specimen between the fixedmember and the movable member of the testing machine canbe either the fixed or self-aligning type.5.1.3.1 Fixed Grips are rigidly attached to the fixed andmovable members of the test
18、ing machine. When this type ofgrip is used extreme care should be taken to ensure that the testspecimen is inserted and clamped so that the long axis of thetest specimen coincides with the direction of pull through thecenterline of the grip assembly.5.1.3.2 Self-Aligning Grips are attached to the fi
19、xed andmovable members of the testing machine in such a manner thatthey will move freely into alignment as soon as any load isapplied so that the long axis of the test specimen will coincidewith the direction of the applied pull through the center line ofthe grip assembly. The specimens should be al
20、igned as per-fectly as possible with the direction of pull so that no rotarymotion that may induce slippage or damage to the sample willoccur in the grips; there is a limit to the amount of misalign-ment self-aligning grips will accommodate.5.1.4 Drive Mechanism, for imparting to the movable mem-ber
21、 a uniform, controlled velocity with respect to the stationarymember, with this velocity to be regulated as specified in 9.3.5.1.5 Load Indicator, a suitable load-indicating mechanismcapable of showing the total tensile load carried by the testspecimen when held by the grips. This mechanism shall be
22、essentially free of inertia lag at the specified rate of testing andshall indicate the load with an accuracy of 61 % of theindicated value, or better. The accuracy of the testing machineshall be verified in accordance with Practices E4.5.2 Temperature-controlling Equipment, capable of main-taining t
23、he test temperature to 62C. If ambient laboratoryconditions are employed the same degree of control is required.Awater bath or environmental chamber capable of maintaining37C is required for testing on tissue substrates.6. Test Substrate6.1 For comparative testing, either fresh or frozen splitthickn
24、ess porcine skin graft may be used.6.1.1 Frozen split thickness porcine skin that has beenaseptically prepared is available commercially and is preferreddue to ease of use and the potential for more consistentproperties. It should be thawed according to the manufacturersinstructions prior to use. Un
25、used graft may be kept at 2 to 8Cfor up to two weeks after thawing.6.1.2 If fresh skin is chosen, it should be prepared accordingthe method in Appendix X1.6.2 Application Specific TestingDue to the size of theT-Peel test specimens, many tissues will not be suitable for thistest.6.2.1 The strength of
26、 any adhesive is highly dependent onthe test substrate, or adherend. For a specific application, thepreferred substrate is freshly harvested tissue from the targetorgan of a domestic food animal. Tissue from bovine, porcine,or ovine origin is preferred due to wide availability and the factthat relat
27、ively 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 immediately after harvesting. Storage andhandling of tissue samples should be carried out according
28、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 temperature) prior to application of theadhesive.6.2.2 Fixed tissue should not be used since it
29、 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.6.2.3 If the target organ is of a size or geometry, or both, thatdoes not allow fabrication of test samples as shown in Fig. 1
30、,a tissue of similar origin but larger size should be used. Forexample, if the intended indication is for anastomosis of smallblood vessels, a larger vessel should be substituted (see 6.2).6.2.4 The thickness of the tissue sample should be mini-mized and should not exceed 5 mm. Thicker samples will
31、leadto distortion of the substrate and mixed loading (shear andtension). It is also important that the thickness be as uniform aspossible.6.3 Substrates for Quality Control Testing:6.3.1 For testing that is undertaken as part of a qualitycontrol process in the manufacturing of a tissue adhesivedevic
32、e, the use of freshly harvested tissue is highly inconve-nient and may also lead to unacceptable variation in the testresults, especially if the failure occurs in the adherend (sub-strate failure). Since the purpose of quality control testing is todemonstrate consistency in the device, substitution
33、of a modelsubstrate is preferred so long as it is demonstrated that theadhesive does bond to the adherand. Due to the nature of theFIG. 1 T-Peel Sample Configuration (Side View)F2256 05 (2015)2T-Peel test, the substrate must be flexible and should havesufficient stiffness to minimize substrate disto
34、rtion during thetest.6.3.2 For devices that require contact with tissues to cure,Mediskin XenoGraft should be used for quality control testingas well as comparative testing.7. Test Specimen7.1 The T-Peel test specimen is shown in Fig. 1.Twosubstrate samples are required for each test.7.1.1 A templat
35、e of the correct dimensions should be used.A sharp scalpel or similar device should be used to cut thesubstrate material.7.1.2 Specimen width should be 2.5 6 0.1 cm.7.1.3 Specimen length should be 15 6 0.2 cm (2.5 cmunbonded, 12.5 cm bonded).7.2 Number of Test SpecimensTest at least 10 specimensof e
36、ach type. Tissue substrates tend to give higher variancesand may require more samples to attain a reasonable estimateof the mean strength.8. Sample Preparation8.1 Tissue Preparation:8.1.1 Tissue substrate materials should be kept moist at alltimes with phosphate buffered saline (PBS).8.1.2 The subst
37、rate will be cut to the dimensions given inSection 7 using a template and a fresh scalpel blade or a cutterfabricated to the required dimensions.8.1.3 Wrap the tissue with gauze soaked in PBS, place in aplastic bag, and place them in a water bath or environmentalchamber at 37C.8.2 Preparation of the
38、 Adhesive Bond:8.2.1 Prepare the test adhesive according to the manufac-turers directions or by other prescribed procedure.8.2.2 Remove the test fixtures from the plastic bag and patthe surface of the tissue dry with fresh gauze.8.2.3 Apply sufficient adhesive to uniformly coat the over-lap area wit
39、hout significant overflow. Excess adhesive couldrun over the edge of the substrate, causing artificially high testvalues. The amount required will have to be determinedexperimentally. For adhesives that are delivered with a spraydevice, controlling the amount and distribution of the materialwill be
40、difficult. It may be necessary to use a template toprevent overspray. Alternatively, petroleum jelly may appliedto the portion of the tissue outside of the overlap area toprevent bonding.8.2.4 Place the other non-glued adherend specimen on topof the glued specimen.8.2.5 Apply a force of approximatel
41、y 5 to 10 N to the bondarea until the adhesive sets. For slow-curing adhesives it maybe necessary to use a clamping device that can be left in placewhile the fixture is returned to the environmental chamber orwater bath.8.3 Measure and record the width and length of the adhesivebond to within 0.05 c
42、m.8.4 Re-cover the tissue with gauze soaked in PBS, replacethe sample in a plastic bag, and return it to the constanttemperature environment.9. Test Procedure9.1 Condition the test specimens for definite periods of timeunder specified, controlled conditions before testing if desired.For comparative
43、testing, the conditioning time should be 1 h 615 min. Recommended conditions for tissue adhesives in-tended for internal applications are 37 6 1C in phosphatebuffered saline. For adhesives intended for external topical use,recommended conditions are 30 6 1C and 50 6 5 % relativehumidity. For quality
44、 control testing, the recommended condi-tions are 23 6 2C and 50 6 5 % relative humidity.9.2 After conditioning, 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
45、must be kept moist throughout theprocess to prevent shrinkage due to drying. For comparativetesting the test conditions should be 23 6 2C and 50 6 5%relative humidity (see Annex A1).9.3 Clamp the unbonded ends of the test specimen in thegrips of the tensile test machine as shown in Fig. 1. Load thes
46、pecimen at a constant cross-head speed of 250 mm/min.9.4 Record the load as a function of displacement, and thetype of failure (percentage cohesive, adhesive, or substratefailure) based on observation of the bond area.10. Calculations10.1 For a bonded length of 12.5 cm, the displacement ofthe test g
47、rips will be approximately 25 cm. Ignore the load datafor the first 2.5 cm of displacement, and calculate the averageload between displacements of 2.5 cm and 22.5 cm.10.2 Calculate the average T-Peel strength by dividing theaverage load in Newtons by the width of the specimen incentimetres.10.3 Calc
48、ulate the average and standard deviation for eachgroup of samples.11. Report11.1 Report the following:11.1.1 Complete identification of the adhesive tested, in-cluding type, source, date manufactured, manufacturers codenumber, and lot number.11.1.2 Complete identification of the substrate used, itst
49、hickness, and any method used to clean or prepare the surfaceprior to bonding.11.1.3 Estimated amount of adhesive applied.11.1.4 Method of adhesive application.11.1.5 Ambient conditions at time of bonding (temperature,humidity, and so forth).11.1.6 Average width of the specimen.11.1.7 Conditioning of specimen prior to testing.11.1.8 Maximum, minimum, mean, and standard deviationof the Peel strength for the group of specimens.11.1.9 Number of specimens tested.F2256 05 (2015)311.1.10 Type of FailureThis should include estimatedpercentages of cohesive failure in
