ГОСТ Р ИСО 14155-1—2008
Библиография
(1] ИСО 14971:2000
(ISO 14971:2000)
ИСО 10993 (все части)
Изделия медицинские. Применение менеджмента риска кмедицинским изделиям
(Medical devices — Application of nsk management to medical devices)
Оценка биологического действия медицинских изделий
ISO 10993 (ell parts)
Biological evaluation of medical devices
European Directives on medical devices. 93/42/EEC from 14 June 1993 and on active Implantable medical devices. 90/385.
EEC from 20 July 1990. as amended
Essential Principles — Global Harmonization Task Force. 1999
International Conference on Harmonization, Harmonized Tripartite Guideline for Good Clinical Practice. 2nd edition. May
1996
Etnical principles for medical research Involving human subjects. World Medical Association, available at
<http:/Avww.wma.net/e/approvedhelsinkl.html>
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