Tag Archives: Standards

Medical device test – electromagnetic compatibility

Posted on by

Electromagnetic compatibility (EMC) is the modern concept that combines such popular electromagnetic phenomena as radio interference, effects on the network, overvoltage, voltage fluctuations in the network, electromagnetic influences, grounding effects, etc. In recent decades, there has been a rapid growth in the development of medical electrical products and systems. EMC for medical devices (MD) can be defined as “the ability

Read more

Climatic zone classification for medical devices

Posted on by

There is a standard GOST 15150 in Russian Federation, which regulates climatic conditions of manufactured devices. It contains normative values of ambient temperatures for different modifications of devices for different climatic areas. According to GOST R 50444 medical devices must comply with requirements of one of these climatic conditions: УХЛ4.2 (English abbreviation see in table below), У1, У1.1, У2, У3,

Read more

Medical device classification in GOST R 50444-92

Posted on by

GOST R 50444-92 (equivalent to GOST 20790-93) is an important standard for many types of medical devices in Russia, and is particularly important for their marketing authorization procedure; however it has several specific features to be mentioned: Despite its vaguely described scope (which is as medical devices, medical apparatus, medical equipment and sets of medical equipment, except X-ray medical equipment

Read more

Medical device labeling

Posted on by

Today we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last

Read more

The number of stomatology material samples for biocompatibility studies

Posted on by

In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number

Read more

Technical regulation in Russia. Introduction

Posted on by

Dear colleagues, we will start our journey into the secrets of Russian standards, concerned with medical devices with a short review of the technical regulation in Russia and the exploration of certification systems GOST, GOST R, GOST R IEC and GOST R ISO. The certification system GOST R – is the biggest certification system in Russia. Moreover, this is the

Read more
« Older Entries