ПРИЛОЖЕНИЕ В
(справочное)
ГОСТ Р ИСО 10993.6-99
Библио
1
рафия
Контрольные материалы
|I| ISO 5832-1:1987. Implants for surgery —Metallic materials —Part I: Wrought stainless steel
(2| ISO 5832-2:1993. Implants for surgery- —Metallic materials —Part 2: Unalloyed titanium
|3) ISO 5832-3:1990. Implants for surgery —Metallic materials - Part 3: Wrought titanium 6-aluminium
4-vanadium alloy
|4| ISO 5832-4:1978, Implants for surgery —Metallic materials —Part 4: Coball-chromium-molybdcnum casting
alloy
|5| ISO 5832-5:1993, Implants for surgery —Metallic materials —Part 5: Wrought cobalt-chromium-tungstcn-
nickel alloy
(6) ISO 5832-6:1980. Implants for surgery —Metallic materials — Pan 6: Wrought cobalt-nickcl-chramium-mo-
lybdcnum alloy
|7| ISO 5832-7:1994. Implants for surgery —Metallic materials —Part 7: Forgeable and coldformed cobalt-chro-
mium-nickcl-molybdcnum-iron alloy
|8| ISO 5832-8:1987, Implants for surgery —Metallic materials —Part 8: Wrought cobalt-nickel-chromium-mo-
lybdcnum-tungstcn-iron alloy
|9| ISO 5834-2:1985. Implants for surgery — Ultrahigh molecular weight polyethylene —Part 2: Moulded forms
|I0| ISO 6474:1994. Implants for surgery —Ceramic materials based on high puritv aluminia
m i BS 5736-2 PRS:1986, Positive control plastic reference standard for implantation.
Национальные стандарты
|12J ASTM F 748. Practice for Selecting Genetic Biological Test Methods for Materials and Devices
1131 ASTM F 736. Practice for Short-Term Screening of Implant Materials
114| ASTM F 981. Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect
to Effect of Materials on Muscle and Bone
115) NF S 90-703:1989. Material medico-chirurgical — Implants chirurgicaux — Essais de tolerance d’un Ьюта-
tcrial destine a entrer en contact avee tissus muscutaircs ct oxseux: implantations a court termc ct a Ion termc
|16| UNI 9582-3:1990. Biocompatibility of Medical Materials and Devices —Bone Implant Test
(I7| U.S. Pharmacopeia XXII: 1990. Biological reactivity test, in-vivo
Дополнительная литература
|I8| Cohen. J. Assay of Foreign-Body Reaction. Journal of Bone and Joint Surgery. 4IA. pp. 152—166 (1959)
119) Ferguson. AB. Jr., Laing. PG. and Hodge. ES. The Ionization of Metal Implants in Living Tissues. Journal
of Bone and Joint Surgery. 42A. pp. 77—90. I960
(20) Gcrct. V., Rahn. BA.. Mathys. R.. Straumann. F. and Pcrren. SM. In vivo Testing of Tissue Tolerance of
Implant Materials: Improved Quantitative Evaluation through Reduction of Relative Motion at the Implant Tissue
Interface. From Current Concepts of Internal Fixation of Fracture. HK. Uhthoff (ed.). Springer Vcriag. 1980
|211 Gcrct, V.. Rahn. BA.. Mathys, R.. Straumann. F. and Perrcn. SM. Chapter 35: A Method for testing Tissue
Tolerance for Improved Quantitative Evaluation Through Reduction of Relative Motion at the Impkint-Tissuc Interface.
Evaluation of Biomalenals. GD. Winter. JL. Lcray. K. dc Groot (cds). John Wiley & Sons Ltd.. 1980
|22) Kaminski. EJ., Oglesby. RJ.. Wood. NK. and Sandrik, J. The Behavior of Biological Materials at Different
Sites of Implantation. Journal of Biomedical Materials Research, 2. pp. 81—S8. 1968
|23J Laing. PG., Ferguson, AB. Jr. and Hodge. ES. Tissue Reaction in Rabbit Muscle Exposed to Metallic
Implants. Journal of Biomedical Materials Research. I. pp. 135—149. 1967
|24) Langcland. K., Gulluso, J.. Langcland. LL. and Tobon, G. Methods in the study of biological response to
endodontic materials. Tissue response to endodontic materials. Tissue rcsponce to #2 (root canal scaleri). Oral Surg, 27,
p. 522. 1969
|25| Pizzofcrrato. S., Savarino, L.. Stca, S. and Tarabusi, C. Result of Histological Grading on 100 cases of Hip
Prosthesis Failure. Biomalenals. 9, pp. 314—328. 1988
|26| Rahn. BA.. Gcrct. V.. C’apaul, C., Lardi, M. and Solothurnmann, B. Morphometric Evaluation of Tissue
Reaction to Implants Using Low Cost Digitizing Techniques. Clinical Applications of Biomalcrials, AJC. Lee. T.
Alberktsson and P.-l. Branemark (cds). John Wiley & Sons Ltd.. 1982
|27| Tomcck. C’D. Reaction of Rat Connective Tissue to Polyethylene Tube Implants. Oral Surg. 21, p. 379. 1966
|28| Tomcck, C’D. Reaction of Rat Connective Tissue to Polyethylene Implants, Oral Surg. 24. p. 674. 1967
|29) Turner. E., Lawrence. WH. and Autian. J. Subacute Toxicity Testing of Biomalcrials Using Histological
Evaluation of Rabbit Muscle Tissue. Journal of Biomedical Materials Research. 7. pp. 39—58. 1973
|30) ГОСТ P 51148—98 Изделия медицинские. Требования к образцам идокументации, представляемым
на токсикологические, санитарно-химические испытания, испытания на стерильность и иирогснностъ
II