ГОСТ Р ИСО 10993-6—2009
Библиография
(1] ISO 5832-1.Implants tor surgery — Metallic materials —
(2] ISO 5832-2.Implants for surgery — Metallic materials —
(3] ISO 5832-3.Implants for surgery — Metallic materials —
(4] ISO 5832-4.Implants for surgery — Metallic materials — (5]
ISO 5832-5.Implants for surgery — Metallic materials —
(6] ISO 5832-6.Implants for surgery — Metallic materials —
Part 1: Wrought stainless steel
Part 2: Unalloyed titanium
Part 3: Wrought titanium 6-alumlnlum 4-vanadlum alloy
Part 4. Cobalt-chromium-motybdenum casting alloy
Part 5. Wrought cobalt-chromlum-tungstenmckel alloy
Part 6: Wrought cobatt-nickel-chromiummotybdenum alloy
(7] ISO 5832-7. Implants for surgery — Metallic materials — Part 7: Forgeable and coldformed cobalt-chromlum-
nickei-molybdenum-iron alloy
[8J ISO 5832-8. Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromlum-molybdenum-
tungsten-iron alloy
[9] ISO 5834-2. Implants for surgery — Ultra-high-molecular-welght polyethylene — Part 2: Moulded forms
[10J ISO 6474. Implants for surgery — Ceramic materials based on high punty alumina
[11) ISO 7405. Dentistry — Preclmical evaluation of blocompatlbillty of medical devices used m dentistry — Test methods
for dental materials
[12) ISO 10993-9. Biological evaluation of medical devices — Part 9: Framework for identification and quantification of
potential degradation products
[13) ASTM F748, Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
[14) ASTM F763. Standard Practice for Short-Term Screening of Implant Materials
[15) ASTM F981. Standard Practice for Assessment of CompabMity of Blomatenals for Surgical Implants with Respect to
Effect of Materials on Muscle and Bone
[16) ASTM F1983. Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Blomatenals for Implant
Applications
[17) MHLW Notification. Principles for Biological Safety Evaluation of Medical Devices: IYAKUSHIN No.0213001
(2003.02.13)
[18) Memorandum. Guidance for Specific Biological Tests relevant to the Principles issued by the MHLW Notification
No.0213001 (2003.02.13): IRYOKIKI-SHINSA No.36 (2003.3.19)
[19) COHEN. J.. Assay of Foreign-Body Reaction. Journal of Bone and Joint Surgery. 41A, 1959. pp. 152 — 166
[20) DE JONG. W.H.. BERGSMA. J.E., ROBINSON, J.E. and BOS. R.R.M., Tissue response to partially In vitro
predegraded poly-L-lacttde implants. Blomatenals, 26. 2005. pp. 1781 — 1791
[21) WISE. D.L.. TRANTOLO. D.J.. ALTOBELLI. D.E.. YAS2EMSKI. M.J., GRESSER. J.D.. SCHWARTZ. E.R. and
DEKKER. M., Evaluating the Biological Effects of Medical Devices. Encyclopedic Handbook of Blomatenals and
Bioengineering, 1. New York. 1995. pp. 422 — 424
[22) FERGUSON. A.B. Jr.. LAING. P.G. and HODGE. E.S.. The Ionization of Metal Implants in Living Tissues. Journal of
Bone and Joint Surgery. 42A. 1960. pp. 77 — 90
[23) GERET. V.. RAHN. B.A.. MATHYS. R.. STRAUMANN. F. and PERREN. S.M.. 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. H.K Uhthoff (ed.). Sprmger Verlag. 1980
[24) GERET. V.. RAHN. B.A.. MATHYS. R.. STRAUMANN. F. and PERREN. S.M.. Chapter 35. A Method for Testing
Tissue Tolerance for Improved Quantitative Evaluation Through Reduction of Relative Motion at the Implant-Tissue
Interface. Evaluation of Blomatenals. G.D. Winter. J.L. Leray. K. de Groot (eds). John Wiley & Sons Ltd., 1980
[25) IKARASHI. Y.. TOYODA. K.. OHSAWA. N.. UCHIMA. T.. TSUCHIYA. T.. KANIWA. M.. SATO. M.. TAKAHASHI. M. and
NAKAMURA, A.. Comparative Studies by Cell Culture and in vivo Implantation Test on the Toxicity of Natural Rubber
Latex Materials, J Btomed Mater Res. 26.1992. pp. 339 — 356
[26) IKARASHI. Y.. TSUCHIYA. T.. TOYODA. K.. KOBAYASHI. E.. DOI. H.. YONEYAMA. T. and HAMANAKA. H.. Tissue
Reactions and Sensitivity to Iron Chromium Alloys. Mater Trans. 43. 2002. pp. 3065 — 3071
[27) KAMINSKI. E.J.. OGLESBY. R.J.. WOOD. N.K. and SANDRIK. J.. The Behavior of Biological Materials at Different
Sites of Implantation. J Biomed Mater Res. 2. 1968, pp. 81 — 88
[28) LAING. P.G.. FERGUSON, A.B. Jr. and HODGE. E.S.. Tissue Reaction In Rabbit Muscle Exposed to Metallic Implants.
J Biomed Mater Res. 1. 1967. pp. 135 — 149
[29J LANGELAND. K.. GUTTUSO. J.. LANGELANO, L.L. and TOBON. G.. Methods in the study of biological response to
endodontic materials. Tissue response to N2 (root canal sealer). Oral Surg. 27. 1969. p. 522
(30) PREUL, M.C., BlCHARD. W.D.. MUENCH. T. and SPETZLER. R.F.. Toward optimal tissue sealants for neurosurgery:
use of a novel hydrogel in a canine durotomy repair model. Neurosurgery. 2003
[31) RAHN. B.A.. GERET. V.. CAPAUL. C „ LARDI. M. and SOLOTHURNMANN. B.. Morphometric Evaluabon of Tissue
Reaction to Implants Using Low Cost Digitizing Techniques. Clinical Applications of Blomatenals. A.J.C. Lee. T.
Albrektsson and P.-L Branemark (eds), John Wiley & Sons Ltd.. 1982
(32) TILNEY, N.L.. Patterns of lymphatic drainage m the adult laboratory rat. J. Anat. 109(3). 1971. pp. 369 — 383
[33) TORNECK. C.D.. Reaction of Rat Connective Tissue to Polyethylene Tube Implants. Oral Surg. 21. 1966. p. 379
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