Evaluation of the Biological Effect of Medical Devices: General Requirements for Biological Safety (Analytical Review)

IF 0.5 Q4 MATERIALS SCIENCE, MULTIDISCIPLINARY Inorganic Materials: Applied Research Pub Date : 2024-10-09 DOI:10.1134/S2075113324700916
V. I. Sevastianov, N. V. Perova, E. V. Arzumanyants, N. M. Perova, N. V. Kaminskaya, I. A. Dovzhik
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Abstract

The main goal of the article is to familiarize specialists working in the field of medical devices (MDs) with existing approaches to the study of their biocompatibility, set out in the standards of the GOST (State Standard) ISO 10993 series. The concept of the GOST (State Standard) ISO 10993 series of standards lies in establishing the biological safety and functional effectiveness of MDs in the terms of biological risk, as necessary and sufficient conditions for biocompatibility of MDs in clinical application. The main attention in the general scheme of assessing the biological safety of MD is paid to the program of toxicological studies (tests), consisting of a set of methods that take into account the category, purpose, and duration of MD functioning.

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医疗器械生物效应评估:生物安全性的一般要求(分析评论)
本文的主要目的是让医疗器械领域的专家熟悉 GOST(国家标准)ISO 10993 系列标准中规定的研究医疗器械生物兼容性的现有方法。GOST (State Standard) ISO 10993 系列标准的概念在于从生物风险的角度确定 MD 的生物安全性和功能有效性,作为 MD 在临床应用中生物兼容性的必要和充分条件。在评估 MD 生物安全性的总体方案中,主要关注的是毒理学研究(试验)计划,其中包括一套考虑到 MD 功能的类别、目的和持续时间的方法。
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来源期刊
Inorganic Materials: Applied Research
Inorganic Materials: Applied Research Engineering-Engineering (all)
CiteScore
0.90
自引率
0.00%
发文量
199
期刊介绍: Inorganic Materials: Applied Research  contains translations of research articles devoted to applied aspects of inorganic materials. Best articles are selected from four Russian periodicals: Materialovedenie, Perspektivnye Materialy, Fizika i Khimiya Obrabotki Materialov, and Voprosy Materialovedeniya  and translated into English. The journal reports recent achievements in materials science: physical and chemical bases of materials science; effects of synergism in composite materials; computer simulations; creation of new materials (including carbon-based materials and ceramics, semiconductors, superconductors, composite materials, polymers, materials for nuclear engineering, materials for aircraft and space engineering, materials for quantum electronics, materials for electronics and optoelectronics, materials for nuclear and thermonuclear power engineering, radiation-hardened materials, materials for use in medicine, etc.); analytical techniques; structure–property relationships; nanostructures and nanotechnologies; advanced technologies; use of hydrogen in structural materials; and economic and environmental issues. The journal also considers engineering issues of materials processing with plasma, high-gradient crystallization, laser technology, and ultrasonic technology. Currently the journal does not accept direct submissions, but submissions to one of the source journals is possible.
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