Abstract: | Editorial note. This article is published as part of a discussion. Particular issues of the article are disputable. First
of all, this concerns the so-called “folder” method of introduction of international standards for medical devices to domestic
medical practice (i.e., by direct translation of the standards and their publication as standardizing documents). Nevertheless,
at least one of the problems, the problem of coordination between domestic state standards for medical devices and international
recommendations of ISO and IEC, is undoubtedly of topical importance. Advancement of new health service legislation which
is to be approved by law-makers will definitely introduce corrections into the present situation. The Editorial Board of Meditsinskaya
Tekhnika believes this article will lessen these problems and to be welcomed by readers. |