ГОСТ ISO 10993-16—2011
Библиография
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1
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ISO 10993-2:1992
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2
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ISO 10993-12:1996
[3]
Biological evaluation of medical devices — Part 2: Animal
welfare requirements
Оценка биологическая медицинских устройств. Часть
2. Требования к благополучию животных
Biological evaluation of medical devices — Part 12:
Sample preparation and reference materials
Оценка биологическая медицинских устройств. Часть
12. Подготовка проб и эталонных материалов
Andersen М.Е., Clewell H.J. Ill, Gargas M.L., Smith F.A.
and Reitz R.H. Physiologically-based pharmacokinetics
and the risk assessment process for methylene chloride.
Toxicol. Appl. Pharmacol. 54: 100—116; 1987
Bogen D.K. Simulation software for the Macintosh.
Science 24: 138—142; 1989
F.D.A. Guidelines for the format and content of the human
pharmacokinetics and bioavailability section of an
application. Department of Health and Human Services
Hattis D., White P., Mamorstein L. and Koch P.
Uncertainties in pharmacokinetic modelling for
perchloroethylene. I. Comparison of model structure,
parameters and predictions for low-dose metabolism rates
derived by different authors. Risk analysis 10: 449—458,
1990
Intematinal Programme on Chemical Safety (IPCS).
Principles of toxicokinetic studies. Environmental Health
Criteria 57, World Health Organization, Geneva, 1986
[8]ISO/TR 10993-9:1994
Biological evaluation of medical devices — Part 9:
Degradation of materials related to biological testing
[9)
Jollow D.J., Roberts S., Price V., Longacre S. and Smith
C. Pharmacokinetic considerations in toxicity testing. Drug
Metab. Rev. 13: 983 — 1007, 1982
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