ASTM F763-2004(2016) Standard Practice for Short-Term Screening of Implant Materials《种植体材料短期筛选的标准实施规程》.pdf

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1、Designation: F763 04 (Reapproved 2016)Standard Practice forShort-Term Screening of Implant Materials1This standard is issued under the fixed designation F763; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revisio

2、n. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides guidelines for short-term testingor screening of candidate materials, both porous and dense, asto the effec

3、ts of the material on animal tissue in which it isimplanted. This is a rapid screening procedure for determiningacceptability of candidate materials.1.2 This practice, along with other appropriate biologicaltests (including other appropriate ASTM tests) may be used inthe biocompatibility assessment

4、of the candidate materials foruse in the fabrication of devices for clinical application.1.3 This experimental protocol is not designed to provide acomprehensive assessment of the systemic toxicity,carcinogenicity, teratogenicity, or mutagenicity of the materialsince other standards deal with these

5、issues.1.4 This practice is one of several developed for theassessment of the biocompatibility of materials. Practice F748provides guidance for the selection of appropriate methods fortesting materials for a specific application.1.5 The values stated in SI units are to be regarded asstandard. No oth

6、er units of measurement are included in thisstandard.1.6 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-bility o

7、f regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 Specification for

8、 Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybde

9、num Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Im

10、plant Applications (UNS R30563) (With-drawn 2005)3F603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF748 Practice for Selecting Generic Biological Test Method

11、sfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 biocompatibility assaya comparison of the tissueresponse produced

12、 through the close association of the im-planted candidate material to its implant site within the hostanimal to that tissue response recognized and established assuitable with control materials.4. Summary of Practice4.1 Under aseptic conditions, test specimens of the candi-date material and of cont

13、rols are inserted into a muscle orgroup of muscles of the animal host. After a period of time the1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current e

14、dition approved April 1, 2016. Published June 2016. Originallyapproved in 1982. Last previous edition approved in 2010 as F763 04 (2010).DOI: 10.1520/F0763-04R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book

15、of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1a

16、nimals are euthanized. The tissue reactions to implants of thecandidate material during the acute to subchronic time periodof healing are compared with tissue reactions to controlmaterials which have a well characterized response. Theimplants are not subject to major stress while in situ.5. Signific

17、ance and Use5.1 The use of in vivo implantation techniques for charac-terizing the biocompatibility of materials to be utilized invarious medical applications provides a unique assessment ofsuch materials not achieved by other procedures. Physicalcharacteristics (that is, form, density, hardness, su

18、rface finish)can influence the character of the tissue response to the testmaterials.5.2 This practice is intended as a rapid screening procedurefor determining the acceptability of candidate materials. Itwould be invoked prior to using the long-term tests describedin Practice F981. It is understood

19、 that for some applicationsadditional tests, including long-term implantation studies, maybe required to assess the final suitability of the candidatematerials.5.3 This practice may not be appropriate for all types ofimplant applications. The user is cautioned to consider theappropriateness of the m

20、ethod in view of the materials beingtested, their potential applications, and the recommendationscontained in Practice F748.6. Test Preparation6.1 Rabbits, rats, or other animals may be used as test hosts.The following procedure is written for New Zealand whiterabbits, a commonly used test host but

21、the procedure can beadapted with few alterations to other test hosts.6.2 Test Hosts and Sites:6.2.1 Choose healthy adult rabbits that weigh more than 2.5kg and whose paravertebral muscles are sufficiently large toallow for implantation of the test specimens.6.2.2 The paravertebral muscle shall serve

22、 as the test site forimplants. (The gluteal muscles of rats have been used as testsites by some investigators.)6.2.3 Preparation of RabbitsOn the day of the implanta-tion or up to 20 h before implantation, clip the fur of theanimals on both sides of the spinal column. Remove loose hair.6.3 Selection

23、 of Control Materials:6.3.1 Selection of control material(s) should be based ontheir prior acceptable use in medical applications similar tothose proposed for the candidate test material and is notrestricted to those listed in 6.3.2.6.3.2 Metallic control materials, which have been demon-strated to

24、elicit minimal tissue reactions, are the metal alloys,such as in Specifications F75, F90, F136, F138, F562,orF563,or a ceramic, such as, alumina F603. A suitable polymericcontrol material is found in polyethylene Specification F648.NOTE 1There are times when use of a positive control can help toclar

25、ify the character of the tissue response to the candidate test sample.6.3.3 If the most appropriate control material is expected toelicit a tissue response greater than that normally observed withNegative Control Plastic or the alloys cited above, samples ofthese latter materials may be implanted as

26、 controls on thesurgical technique.7. Test Specimens7.1 FabricationEach implant shall be fabricated, finished,and its surface cleaned in a manner appropriate for its projectedapplication in humans. Dense metal implants should be fin-ished in accordance with Practice F86. The size, shape, andsurface

27、of test and control implants shall be as similar as ispractically possible.7.2 Implant sizes are left to the discretion of the investigator.Implants in the size range 1 by 10 mm (0.04 by 0.4 in.) to 3.2by 12 mm (0.125 by 0.5 in.) have often been used. They maybe of circular or square cross section.

28、The edges of thespecimens should be as smooth as possible to avoid additionalmechanical trauma upon implantation.7.3 Implantation Period:7.3.1 The insertion of all implants into any one animal shallbe done at the same surgical session.7.3.2 Implant evaluation should be performed at 7 and 30 dso that

29、 an accurate characterization of both the test and controlmaterials can be made during the acute and subchronic stagesof the healing tissue response. Three animals shall be used foreach sample period, that is, 3 at 7 d, and 3 at 30 d.NOTE 2Some investigators have found that extending the test toincl

30、ude a third group of animals maintained for 90 d can provideadditional data on the host response to the implant material.48. Procedure8.1 Implantation:8.1.1 The recommended method of implantation is byhypodermic needle or tube and trochar. For larger diametersamples, an incision of appropriate size

31、will be required topermit passage of the larger diameter tube. If this technique isnot convenient, however, other equivalent implantation tech-niques judged appropriate may be used. These should bereported as in 9.1. The implantation shall be done using asepticprocedures.8.1.2 Preparation of Test Sp

32、ecimensThe specimensshould be fabricated as described in 7.1 and prepared forimplantation following the procedure in either 8.1.2.1 or8.1.2.2.8.1.2.1 Sterilize each specimen as appropriate for finalapplication and, using aseptic technique, insert it into a sterileneedle or tube; or,8.1.2.2 Insert th

33、e specimen into a needle or tube, protect theends with an appropriate cover, and sterilize the assemblies inan appropriate manner.NOTE 3Allow for proper degassing if sterilizing agents such asethylene oxide are used.NOTE 4If the materials to be tested are harder than the materials fromwhich the hand

34、ling instruments are made, there is the danger of surfacecontamination of the test specimens by wear from the instruments which4Turner, E., Lawrence, W. H., and Autian, J., “Subacute Toxicity Testing ofBiomaterials Using Histopathological Evaluation of Rabbit Muscle Tissue,” Journalof Biomedical Mat

35、erials Research, Vol 7, 1973, pp. 3958.F763 04 (2016)2can affect the results (for example, ceramic test specimens implanted withmetal instruments). If such test specimens must be handled, soft textile orplastic should be used between the implants and the instruments. Ofcourse, care must be taken tha

36、t none of these auxiliary protecting materialsremain in the implantation wound.8.1.3 The animals should be anesthetized with a commonlyused anesthetic agent deep enough to prevent muscularmovement, such as twitching. Properly scrub the clipped skinsurface of the animal.8.1.4 Implant four specimens o

37、f the sample into the para-vertebral muscle on one side of the spine of each rabbit, about2.5 cm from the mid-line and parallel to the spinal columns,and about 2.5 cm apart from each other. In a similar fashion,implant four specimens of the control material in the corre-sponding muscle on the opposi

38、te side of the spine of eachanimal.8.1.5 In cases where the negative control is other thanspecified in 6.3.2 and may be expected to elicit more than aminimal response, use only two test specimens of this negativecontrol. Implant these two control specimens in a location thatwill not interfere with t

39、he test samples.8.1.6 When using a sterile needle for insertion, insert asterile stylet into the needle to hold the test specimen in thetissue while withdrawing the needle. With trocar implantation,insert the test specimen after withdrawing the central point anduse a stylet to hold the sample while

40、withdrawing the cannula.8.1.7 If excessive bleeding is observed after implantation ofa test specimen, place a duplicate test specimen at another site.Close the incision after implantation is complete, if applicable.If a test host other than the rabbit is chosen, use as manyanimals as are necessary t

41、o permit the implantation of 12 testspecimens and 12 controls for each sacrifice interval.8.2 Postoperative Care:8.2.1 All animal studies must be done, in a facility approvedby a nationally recognized organization and in accordance withall appropriate regulations.8.2.2 Carefully observe each animal

42、during the period ofassay and report any abnormal findings.8.2.3 If an animal dies prior to the expected date of sacrifice,perform a necropsy to determine the cause of death. Include theanimal in the assay of data if the cause of death is related to theprocedure or test material.8.2.4 A successful t

43、est is one in which eight test specimensand eight controls for each test period are available forhistologic evaluation.8.2.5 Should infection or injury of the test implant siteinvalidate the results, replace the animal with another ifnecessary as described in 8.2.4.8.3 Sacrifice and Implant Retrieva

44、l:8.3.1 Sacrifice animals at the intervals suggested in 7.3.2.8.3.2 At sacrifice, record any gross abnormalities of color orconsistency observed in the tissue surrounding the implant.Documentation of findings using photography for a permanentrecord is highly recommended.8.4 Gross Observations, Acute

45、 Test (7 d) and SubchronicTest (30 d):8.4.1 Macroscopically examine the area of the tissue sur-rounding the center portion of each implanted test specimen.Use a magnifying glass, if necessary.8.4.2 The requirements of the test are met if, in each animalthe reaction to three of four sample test speci

46、mens is notsignificantly greater than that of the reaction to the correspond-ing negative control. In situations in which two types ofnegative controls are included, these criteria apply to the tissuesurrounding specimens of the minimally reactive material.8.5 Histopathological Observation, Acute Te

47、st (7 d), andSubchronic Test (30 d):8.5.1 Tissue Sample Preparation:8.5.1.1 Remove each implant with an intact envelope ofsurrounding tissue. The tissue sample should include a 4-mmthick layer of tissue surrounding the implants. If less than 4mm of tissue is removed, report in accordance with 9.1.Pr

48、ocess the excised tissue block containing either a test implantor control implant for histopathological and such other studiesas are appropriate. Cut the tissue sample into appropriatespecimens for each study. Record the gross appearance of theimplant and the tissue immediately adjacent to the impla

49、nt asto consistency and color, as seen by the naked eye, and with ahand lens or stereomicroscope (see 9.2).8.5.1.2 If possible, process the specimen with the implant inplace. This allows easy identification of the implant site andminimizes distortion during fixation.After fixation, the implantmaterial can be removed if necessary, and the tissue specimensprocessed for sectioning using standard laboratory practice forembedding and staining. If an implant is removed from itstissue bed, report the amount of tissue removed with theimplant as required in 9.1.8.5.1.3 Histological