Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases. These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and
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According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence
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In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation of this type of product, as well as to the basic procedures that make up the life cycle of BMCP. However, this article is devoted directly to BMCP – the newest and promising method of treatment of cancer, in particular
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Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of
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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
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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
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Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is due to the fact that this type of product provides a fundamentally new approach to the treatment of many diseases: malignant neoplasms, cardiovascular diseases, diseases of the nervous system and musculoskeletal system, as well as diabetes mellitus. BMCP is
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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
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Sunscreens are an integral part of protection against aggressive solar radiation. The modern market of cosmetic products offers a wide range of different sunscreen products containing a set of components that help protect the skin from the harmful effects of solar radiation. It should be noted that there are two types of UV radiation: UFA and UVB. UVA radiation does
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There are substances in our body that can destroy different cells and useful compounds. They are called free radicals. For example, two collagen molecules, which became free radicals, when collided with oxygen radicals, become so active that they can bind each other. Normal collagen cannot behave like that. Linked collagen is less elastic than normal one and holds water less
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