ГОСТ Р ИСО 14155-1-2008 Руководство по проведению клинических испытаний медицинских изделий. Часть 1. Общие требования

[1] ИСО 14971:2000

Изделия медицинские. Применение менеджмента риска к медицинским изделиям

(ISO 14971:2000)

(Medical devices - Application of risk management to medical devices)

ИСО 10993 (все части)

Оценка биологического действия медицинских изделий

ISO 10993 (all 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

Ethical principles for medical research involving human subjects, World Medical Association, available at <http://www.wma.net/e/approvedhelsinki.html>