V. I. Sevastianov, N. V. Perova, E. V. Arzumanyants, N. M. Perova, N. V. Kaminskaya, I. A. Dovzhik
{"title":"Evaluation of the Biological Effect of Medical Devices: General Requirements for Biological Safety (Analytical Review)","authors":"V. I. Sevastianov, N. V. Perova, E. V. Arzumanyants, N. M. Perova, N. V. Kaminskaya, I. A. Dovzhik","doi":"10.1134/S2075113324700916","DOIUrl":null,"url":null,"abstract":"<p>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 <i>GOST</i> (State Standard) ISO 10993 series. The concept of the <i>GOST</i> (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.</p>","PeriodicalId":586,"journal":{"name":"Inorganic Materials: Applied Research","volume":"15 5","pages":"1300 - 1310"},"PeriodicalIF":0.5000,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Inorganic Materials: Applied Research","FirstCategoryId":"1085","ListUrlMain":"https://link.springer.com/article/10.1134/S2075113324700916","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MATERIALS SCIENCE, MULTIDISCIPLINARY","Score":null,"Total":0}
引用次数: 0
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.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
