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Medical device test – electromagnetic compatibility

Posted on Wednesday November 11th, 2020 by beawire

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

MD regulation

Climatic zone classification for medical devices

Posted on Thursday June 28th, 2018 by beawire

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,

MD regulation

Medical device classification in GOST R 50444-92

Posted on Thursday June 14th, 2018 by beawire

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

MD regulation

Labeling of secondary (rechargeable) batteries for medical devices

Posted on Monday June 4th, 2018 by beawire

Labeling of accumulators as a part of medical devices is required – full information in our new technical regulation issue.

Labeling of active medical devices

Posted on Monday April 23rd, 2018 by beawire

In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1. Table 1 – Necessary symbols Power source parameters 1. Power (I or P) Consuming current or power GOST R

Medical device labeling

Posted on Friday April 6th, 2018 by beawire

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

The number of stomatology material samples for biocompatibility studies

Posted on Thursday March 22nd, 2018 by beawire

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

Every GOST R is a National Standard but not every National Standard is GOST R

Posted on Friday March 9th, 2018 by beawire

Technical regulation – 2018. Part 3.

How to define necessary numbers of samples for biocompatibility trials?

Posted on Thursday February 22nd, 2018 by beawire

Necessary number of medical device samples for toxicological testing.

Technical regulation in Russia. Introduction

Posted on Wednesday February 14th, 2018 by beawire

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

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