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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">cardiovascular</journal-id><journal-title-group><journal-title xml:lang="ru">Кардиоваскулярная терапия и профилактика</journal-title><trans-title-group xml:lang="en"><trans-title>Cardiovascular Therapy and Prevention</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1728-8800</issn><issn pub-type="epub">2619-0125</issn><publisher><publisher-name>«SILICEA-POLIGRAF» LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.15829/1728-8800-2020-2710</article-id><article-id custom-type="elpub" pub-id-type="custom">cardiovascular-2710</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>БИОБАНКИРОВАНИЕ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>BIOBANKING</subject></subj-group></article-categories><title-group><article-title>На пути к созданию общего глоссария биобанков Российской Федерации</article-title><trans-title-group xml:lang="en"><trans-title>Towards the creation of a unified glossary of Russian biobanks</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-5020-9561</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Михайлова</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mikhailova</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Анастасия Алексеевна Михайлова — младший научный сотрудник лаборатории геномики с группой биоресурсных коллекций, младший научный сотрудник лаборатории биобанкинга и геномной медицины</p><p>SPIN-код <ext-link xlink:href="https://www.elibrary.ru/author_info.asp?isold=1" ext-link-type="uri">2675-5857</ext-link></p><p>Санкт-Петербург</p></bio><bio xml:lang="en"/><email xlink:type="simple">anamikhajlova@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3543-4963</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Насыхова</surname><given-names>Ю. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Nasykhova</surname><given-names>Yu. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Юлия Алмазовна Насыхова — кандидат биологических наук, зав. лабораторией геномики с группой биоресурсных коллекций, старший научный сотрудник лаборатории биобанкинга и геномной медицины</p><p>Санкт-Петербург</p><p> </p></bio><bio xml:lang="en"><p>St. Petersburg</p><p> </p></bio><email xlink:type="simple">yulnasa@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2901-1008</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Муравьев</surname><given-names>А. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Muravyov</surname><given-names>A. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Артем Игоревич Муравьев — исполнительный директор</p><p>Москва</p></bio><bio xml:lang="en"/><email xlink:type="simple">aim@qvadrosbio.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0696-1369</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ефименко</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Efimenko</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Анастасия Юрьевна Ефименко — секретарь правления, кандидат медицинских наук, зав. лабораторией репарации и регенерации тканей Института регенеративной медицины, доцент кафедры биохимии и молекулярной медицины факультета фундаментальной медицины</p><p>Москва</p></bio><bio xml:lang="en"/><email xlink:type="simple">efimenkoan@gmail.com</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7465-4504</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Глотов</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Glotov</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Андрей Сергеевич Глотов — доктор биологических наук, руководитель отдела геномной медицины, зав. лабораторией биобанкинга и геномной медицины, вице-президент НАСБИО</p><p>Санкт-Петербург</p><p> </p></bio><bio xml:lang="en"/><email xlink:type="simple">anglotov@mail.ru</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт акушерства, гинекологии и репродуктологии им. Д.О. Отта»; &#13;
ФГБОУ ВО «Санкт-Петербургский государственный университет»</institution></aff><aff xml:lang="en"><institution>D. O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; &#13;
Saint Petersburg State University</institution></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Национальная ассоциация биобанков и специалистов по биобанкированию</institution></aff><aff xml:lang="en"><institution>National Association of Biobanks and Biobanking Specialists</institution></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Национальная ассоциация биобанков и специалистов по биобанкированию; &#13;
МНОЦ МГУ имени М.В. Ломоносова; &#13;
ФГБОУ ВО «Московский государственный университет имени М.В.Ломоносова»</institution></aff><aff xml:lang="en"><institution>National Association of Biobanks and Biobanking Specialists; &#13;
Lomonosov Moscow State University Medical Research and Education Center; &#13;
Lomonosov Moscow State University</institution></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт акушерства, гинекологии и репродуктологии им. Д.О. Отта»; &#13;
ФГБОУ ВО «Санкт-Петербургский государственный университет»;&#13;
Национальная ассоциация биобанков и специалистов по биобанкированию</institution></aff><aff xml:lang="en"><institution>D. O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; &#13;
Saint Petersburg State University; &#13;
National Association of Biobanks and Biobanking Specialists</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2020</year></pub-date><pub-date pub-type="epub"><day>24</day><month>12</month><year>2020</year></pub-date><volume>19</volume><issue>6</issue><fpage>2710</fpage><lpage>2710</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Михайлова А.А., Насыхова Ю.А., Муравьев А.И., Ефименко А.Ю., Глотов А.С., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Михайлова А.А., Насыхова Ю.А., Муравьев А.И., Ефименко А.Ю., Глотов А.С.</copyright-holder><copyright-holder xml:lang="en">Mikhailova A.A., Nasykhova Y.A., Muravyov A.I., Efimenko A.Y., Glotov A.S.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://cardiovascular.elpub.ru/jour/article/view/2710">https://cardiovascular.elpub.ru/jour/article/view/2710</self-uri><abstract><p>Для выполнения научно-исследовательских проектов, клинических испытаний и других исследований в области персонализированной медицины необходимо наличие коллекций охарактеризованных высококачественных биологических образцов различного типа. С развитием технологий в области биомедицины потребность в больших коллекциях биологических образцов всевозможных нозологий будет расти с каждым годом, что обуславливает необходимость создания биобанков различной направленности для стандартизированного сбора, хранения и распространения таких образцов. Одной из целей Национальной ассоциации биобанков и специалистов по биобанкированию (НАСБИО) является развитие сети биобанков в России, взаимодействующих между собой на различных уровнях, а также разработка и внедрение организационно-правовых инструментов регулирования сферы биобанкирования. Для реализации данного направления требуется не только стандартизация процессов доступа к биологическим образцам и данным, а также обмена ими, но и создание общей терминологии, которая будет использоваться биобанками на всей территории России. Основная цель подготовки глоссария — это создание точного, профессионального и юридически грамотного инструмента, содержащего доступную и понятную широкому кругу исследователей информацию.</p></abstract><trans-abstract xml:lang="en"><p>To carry out research projects, clinical trials and other studies in the field of personalized medicine, it is necessary to have collections of high-quality biological samples of various types. With the development of biomedical technologies, the need for large collections of biological samples will grow every year, which necessitates the creation of various biobanks for standardized collection, storage and distribution of such samples. One of the goals of the National Association of Biobanks and Biobanking Specialists is the development of a network of Russian biobanks interacting with each other at various levels, as well as the development and implementation of organizational and legal tools for its regulation. It is required not only to standardize the access and exchange of biological samples and data, but also to create a unified terminology that will be used by biobanks throughout Russia. The main aim is to create an accurate, professional and legally correct tool containing information accessible and understandable to a wide range of researchers.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>биобанк</kwd><kwd>биобанкирование</kwd><kwd>глоссарий</kwd><kwd>стандартизация</kwd><kwd>терминология</kwd><kwd>тезаурус</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biobank</kwd><kwd>biobanking</kwd><kwd>glossary</kwd><kwd>standardization</kwd><kwd>terminology</kwd><kwd>thesaurus</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Исследование проведено при информационной поддержке Национальной ассоциации биобанков и специалистов по биобанкированию (А. И. Муравьев, А. Ю. Ефименко,  А. С. Глотов),  а  также  частично  поддержано в рамках темы фундаментальных научных исследований (ФНИ) № АААА-А19-119021290033-1 (А. А. Михайлова, Ю. А. Насыхова, А. С. Глотов), темы прикладных научных исследований (0908) в рамках государственного задания МНОЦ МГУ им. М. В. Ломоносова (А. Ю. Ефименко).</funding-statement><funding-statement xml:lang="en">The study was carried out with the informational support of the National Association of Biobanks and Biobanking Specialists (Muravyov A. I., Efimenko A. Yu., Glotov A. S.) and also partially supported within the fundamental research theme № АААА-А19-119021290033-1 (Mikhailova A. A., Nasykhova Yu. A., Glotov A. S.) and applied research theme (0908) as a part of the state assignment of the Lomonosov Moscow State University (Efimenko A. Yu.).</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Yuille M, van Ommen GJ, Bréchot C, et al. Biobanking for Europe. Brief Bioinform. 2008;9(1):14-24. doi:10.1093/bib/bbm050.</mixed-citation><mixed-citation xml:lang="en">Yuille M, van Ommen GJ, Bréchot C, et al. Biobanking for Europe. Brief Bioinform. 2008;9(1):14-24. doi:10.1093/bib/bbm050.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Harris JR, Burton P, Knoppers BM, et al. Toward a roadmap in global biobanking for health. Eur J Hum Genet. 2012;20:1105-11. doi:10.1038/ejhg.2012.96.</mixed-citation><mixed-citation xml:lang="en">Harris JR, Burton P, Knoppers BM, et al. Toward a roadmap in global biobanking for health. Eur J Hum Genet. 2012;20:1105-11. doi:10.1038/ejhg.2012.96.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Mate S, Kampf M, Rödle W, et al. Pan-European Data Harmonization for Biobanks in ADOPT BBMRI-ERIC. Appl Clin Inform. 2019;10(04):679-92. doi:10.1055/s-0039-1695793.</mixed-citation><mixed-citation xml:lang="en">Mate S, Kampf M, Rödle W, et al. Pan-European Data Harmonization for Biobanks in ADOPT BBMRI-ERIC. Appl Clin Inform. 2019;10(04):679-92. doi:10.1055/s-0039-1695793.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Norlin L, Fransson MN, Eriksson M, et al. A minimum data set for sharing biobank samples, information, and data: MIABIS. Biopreserv Biobank. 2012;10:343-8. doi:10.1089/bio.2012.0003.</mixed-citation><mixed-citation xml:lang="en">Norlin L, Fransson MN, Eriksson M, et al. A minimum data set for sharing biobank samples, information, and data: MIABIS. Biopreserv Biobank. 2012;10:343-8. doi:10.1089/bio.2012.0003.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Fransson MN, Rial-Sebbag E, Brochhausen M, Litton JE. Toward a common language for biobanking. Eur J Hum Genet. 2015;23:22-8. doi:10.1038/ejhg.2014.45.</mixed-citation><mixed-citation xml:lang="en">Fransson MN, Rial-Sebbag E, Brochhausen M, Litton JE. Toward a common language for biobanking. Eur J Hum Genet. 2015;23:22-8. doi:10.1038/ejhg.2014.45.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Biobank Sverige. Glossary and Terminology: https://biobanksverige.se/english/research/useful-resources/glossaryand-terminology/ (13.10.2020).</mixed-citation><mixed-citation xml:lang="en">Biobank Sverige. Glossary and Terminology: https://biobanksverige.se/english/research/useful-resources/glossaryand-terminology/ (13.10.2020).</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Ellis H, Joshi MB, Lynn AJ, Walden A. Consensus-Driven Development of a Terminology for Biobanking, the Duke Experience. Biopreserv Biobank. 2017;15(2):126-33. doi:10.1089/bio.2016.0092.</mixed-citation><mixed-citation xml:lang="en">Ellis H, Joshi MB, Lynn AJ, Walden A. Consensus-Driven Development of a Terminology for Biobanking, the Duke Experience. Biopreserv Biobank. 2017;15(2):126-33. doi:10.1089/bio.2016.0092.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Campbell LD, Astrin JJ, DeSouza Y, et al. The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team’s Development Process. Biopreserv Biobank. 2018;16(1):36. doi:10.1089/bio.2018.0001.</mixed-citation><mixed-citation xml:lang="en">Campbell LD, Astrin JJ, DeSouza Y, et al. The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team’s Development Process. Biopreserv Biobank. 2018;16(1):36. doi:10.1089/bio.2018.0001.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Anisimov SV, Meshkov AN, Glotov AS, et al. National Association of Biobanks and Biobanking Specialists: New Community for Promoting Biobanking Ideas and Projects in Russia. Biopreserv Biobank. 2020. doi:10.1089/bio.2020.0049.</mixed-citation><mixed-citation xml:lang="en">Anisimov SV, Meshkov AN, Glotov AS, et al. National Association of Biobanks and Biobanking Specialists: New Community for Promoting Biobanking Ideas and Projects in Russia. Biopreserv Biobank. 2020. doi:10.1089/bio.2020.0049.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Grewal J, Mayrhofer MTh. (2019, April 1). BBMRI-ERIC ELSI Glossary. Zenodo. 2019. doi:10.5281/zenodo.3754255.</mixed-citation><mixed-citation xml:lang="en">Grewal J, Mayrhofer MTh. (2019, April 1). BBMRI-ERIC ELSI Glossary. Zenodo. 2019. doi:10.5281/zenodo.3754255.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Акопян Ж. А., Габбасова Л. А., Сурина Е. Р. Справочник международных терминов, применяемых в области биомедицины. Москва: Можайский полиграфический комбинат, 2019. с.255. ISBN: 978-5-8493-0448-9.</mixed-citation><mixed-citation xml:lang="en">Akobyan ZhA, Gabbasova LA, Surina ER. Directory of international terms used in biomedicine. Moscow: Mozhajskij poligraficheskij kombinat, 2019. p.255. (In Russ.) .</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Резник О.Н., Кузьмин Д.О., Скворцов А. Е., Резник А. О. Биобанки — неоценимый ресурс трансплантации. История, современное состояние, перспективы. Вестник трансплантологии и искусственных органов. 2016;18(4):123-32. doi:10.15825/1995-1191-2016-4-123-132.</mixed-citation><mixed-citation xml:lang="en">Reznik ON, Kuz`min DO, Skvorczov AE, Reznik AO. Biobanks are an essential tool for transplantation. History, current state, perspectives. Russian Journal of Transplantology and Artificial Organs. 2016;18(4):123-32. (In Russ.) doi:10.15825/1995-1191-2016-4-123-132.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Брызгалина Е. В., Аласания К. Ю., Вархотов Т. А. и др. Биобанкинг: социально-гуманитарные аспекты. Москва: Издательство МГУ, 2018. с.232. ISBN: 9785-19-011342-6.</mixed-citation><mixed-citation xml:lang="en">Bryzgalina EV, Alasaniya KYu, Varkhotov TA, et al. Biobanking: social and humanitarian aspects. Moscow: Izdatel`stvo MGU, 2018. p.232. (In Russ.). ISBN: 9785-19-011342-6.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Решение Коллегии Евразийской экономической комиссии от 21.04.2015 N 30 (ред. от 11.08.2020) “О мерах нетарифного регулирования”, Приложение N 2. Перечень товаров, в отношении которых установлен разрешительный порядок ввоза на таможенную территорию Евразийского экономического союза и (или) вывоза с таможенной территории Евразийского экономического союза. http://www.consultant.ru/document/cons_doc_LAW_178556/ (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Decision of the Board of the Eurasian Economic Commission dated April 21, 2015 N 30 (as revised on 08.11.2020) “On measures of non-tariff regulation”, Appendix N 2. The list of goods for which the authorization procedure for import into the customs territory of the Eurasian Economic Union and (or) export from the customs territory of the Eurasian Economic Union. (In Russ.) http://www.consultant. ru/document/cons_doc_LAW_178556/ (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Федеральный закон “О биомедицинских клеточных продуктах” от 23.06.2016 N 180-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_199967/ (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On Biomedical Cell Products” of 23.06.2016 N 180FZ. (In Russ.) Федеральный закон “О биомедицинских клеточных продуктах” от 23.06.2016 N 180-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_199967/ (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">National Cancer Institute, USA. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms (04 December 2020).</mixed-citation><mixed-citation xml:lang="en">National Cancer Institute, USA. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms (04 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">International Organization for Standardization. ISO 9000:2015 Quality management systems — Fundamentals and vocabulary. Washington, D.C.: American National Standards Institute (ANSI), 2015. p.58. ISBN: 978-9267107127.</mixed-citation><mixed-citation xml:lang="en">International Organization for Standardization. ISO 9000:2015 Quality management systems — Fundamentals and vocabulary. Washington, D.C.: American National Standards Institute (ANSI), 2015. p.58. ISBN: 978-9267107127.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р 52379-2005 Надлежащая клиническая практика. Москва: Стандартинформ, 2005. с.39. http://www. standards.ru/document/4145941.aspx (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R 52379-2005 Good clinical practice. Moscow: Standartinform, 2005. p.39. (In Russ.) http://www. standards.ru/document/4145941.aspx (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р 534342009 Принципы надлежащей лабораторной практики. Москва: Стандартинформ, 2010. с.16. http://www.standards.ru/document/4559529.aspx (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R 53434-2009 Рrinciples of good laboratory practice. Moscow: Standartinform, 2010. p.16. (In Russ.) http://www.standards.ru/document/4559529.aspx (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р 51901.1-2002 Менеджмент риска. Анализ риска технологических систем. Москва: Стандартинформ, 2003. с.28. http://www.standards.ru/document/4146787.aspx (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R 51901.1-2002 Risk management. Risk analysis of technological systems. Moscow: Standartinform, 2003. p.28. (In Russ.) http://www.standards.ru/document/4146787.aspx (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Струтынский А. В., Мурашко В. В., Баранов А. П. Схема истории болезни. Методические указания для студентов II-VI курсов медицинских институтов. Под редакцией профессора А. В. Струтынского. Москва: ГБОУ ВПО РНИМУ им. Н. И. Пирогова Минздрава России, 2013. с.28. http://marc.rsmu.ru:8020/marcweb2/Default.asp (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Strutynsky AV, Murashko VV, Baranov AP. Case history diagram. Methodical instructions for students of II-VI courses of medical institutes. Edited by Professor AV Strutynsky. Moscow: GBOU VPO RNIMU them. N. I. Pirogov, Ministry of Health of Russia, 2013. p. 28. (In Russ.) http://marc.rsmu.ru:8020/marcweb2/Default.asp (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ 33647-2015 Принципы надлежащей лабораторной практики (GLP). Термины и определения. Москва: Стандартинформ, 2019. с.20. http://www.standards.ru/document/6110690.aspx (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST 33647-2015 Principles of good laboratory practice (GLP). Terms and definitions. Moscow: Standartinform, 2019. p.20. (In Russ.) http://www.standards.ru/document/6110690.aspx (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Приказ Министерства промышленности и торговли Российской Федерации от 14.06.2013 N 916 (ред. от 18.12.2015 N 4148) “Об утверждении Правил надлежащей производственной практики”. http://www.consultant.ru/document/cons_doc_LAW_152004/ (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 N 916 (as amended on December 18, 2015 N 4148) “On Approval of the Rules of Good Manufacturing Practice”. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_152004/ (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Williams DF. The Williams Dictionary of Biomaterials. Liverpool: Liverpool University Press, 1999. p.343. ISBN 0853237344.</mixed-citation><mixed-citation xml:lang="en">Williams DF. The Williams Dictionary of Biomaterials. Liverpool: Liverpool University Press, 1999. p.343. ISBN 0853237344.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р ИСО 10015-2007 Менеджмент организации. Руководящие указания по обучению (Переиздание). Москва: Стандартинформ, 2008. с.16. http://www.standards.ru/document/4181422.aspx (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R ISO 10015-2007 Enterprise management. Guidelines for training. Moscow, Standartinform: 2008. p.16. (In Russ.) http://www.standards.ru/document/4181422.aspx (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Решение Совета Евразийской экономической комиссии от 3.11.2016 N 77 “Об утверждении Правил надлежащей производственной практики Евразийского экономического союза”. http://www.consultant.ru/document/cons_doc_LAW_207780/ (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 77 “On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Community”. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_207780/ (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Федеральный закон “Об основах охраны здоровья граждан в Российской Федерации” от 21.11.2011 N 323-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_121895/ (07 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On the Basics of Health Protection of Citizens in the Russian Federation” dated November 21, 2011 N 323-FZ. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_121895/ (07 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Федеральный закон “О техническом регулировании” от 27.12.2002 N 184-ФЗ. http://www.consultant.ru/ document/cons_doc_LAW_40241/ (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On Technical Regulation” dated 27.12.2002 N 184FZ. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_40241/ (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">Федеральный закон “Об обращении лекарственных средств” от 12.04.2010 N 61-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_99350/ (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On the Circulation of Medicines” dated 12.04.2010 N 61-FZ. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_99350/ (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р ИСО 18113-1-2015 Медицинские изделия для диагностики in vitro. Информация, предоставляемая изготовителем (маркировка). Москва: Стандартинформ, 2016. с.46. http://www.standards.ru/document/6108060.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Moscow: Standartinform, 2016. p.46. (In Russ.) http://www.standards.ru/document/6108060.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р 22.0.04-95 Безопасность в чрезвычайных ситуациях. Биолого-социальные чрезвычайные ситуации. Термины и определения. Москва: Издательство стандартов, 1995. с.16. http://www.standards.ru/document/4147509.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R 22.0.04-95 Safety in emergencies. Biologist social emergencies. Terms and definitions. Moscow: Izdatel’stvo standartov, 1995. p.16. (In Russ.) http://www.standards.ru/document/4147509.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">Проект Федерального закона N 850485-7 “О биологической безопасности Российской Федерации” (ред., принятая ГД ФС РФ в I чтении 21.01.2020). http://www.consultant.ru/cons/cgi/online.cgi?req=doc&amp;base=PRJ&amp;n=190962#012421350459205582 (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Draft Federal Law N 850485-7 “On Biological Safety of the Russian Federation” (ed., Adopted by the State Duma of the Federal Assembly of the Russian Federation in the 1st reading on January 21, 2020). (In Russ.) http://www.consultant.ru/cons/cgi/online.cgi?req=doc&amp;base=PRJ&amp;n=190962#012421350459205582 (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">Sixty-third World Health Assembly, 21.05.2010. Human organ and tissue transplantation. Document A63/24. WHA63.22. 2010. p.3. https://apps.who.int/gb/e/e_wha63.html (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Sixty-third World Health Assembly, 21.05.2010. Human organ and tissue transplantation. Document A63/24. WHA63.22. 2010. p.3. https://apps.who.int/gb/e/e_wha63.html (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit34"><label>34</label><citation-alternatives><mixed-citation xml:lang="ru">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Geneva, 2004. p.16. https://www.ich.org/page/quality-guidelines (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Geneva, 2004. p.16. https://www.ich.org/page/quality-guidelines (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit35"><label>35</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р ИСО 14644-1-2017 Чистые помещения и связанные с ними контролируемые среды. Москва: Стандартинформ, 2019. с.29. http://www.standards.ru/document/6339569.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R ISO 14644-1-2017 Cleanrooms and associated controlled environments. Moscow: Standartinform, 2019. p.36. (In Russ.) http://www.standards.ru/document/6339569.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit36"><label>36</label><citation-alternatives><mixed-citation xml:lang="ru">Федеральный закон “О персональных данных” от 27.07.2006 № 152-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_61801/ (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On Personal Data” dated July 27, 2006 No. 152FZ. (In Russ.) Федеральный закон “О персональных данных” от 27.07.2006 № 152-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_61801/ (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit37"><label>37</label><citation-alternatives><mixed-citation xml:lang="ru">World Health Organization Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute. Laboratory quality management system: handbook. Lyon: World Health Organization, 2011. p.247. ISBN: 9789241548274.</mixed-citation><mixed-citation xml:lang="en">World Health Organization Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute. Laboratory quality management system: handbook. Lyon: World Health Organization, 2011. p.247. ISBN: 9789241548274.</mixed-citation></citation-alternatives></ref><ref id="cit38"><label>38</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р ИСО 14155-2014 Клинические исследования. Надлежащая клиническая практика. Москва: Стандартинформ, 2015. с.54. http://www.standards.ru/document/5352790.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R ISO 14155-2014 Clinical investigation. Good clinical practice. Moscow: Standartinform, 2015. p.54. http://www.standards.ru/document/5352790.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit39"><label>39</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ 1.1-2002 Межгосударственная система стандартизации (МГСС). Термины и определения. Москва: Издательство стандартов, 2003. с.40. http://www.standards.ru/document/4162330.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST 1.1-2002 Interstate system for standardization. Terms and definitions. Moscow: Izdatel’stvo standartov, 2003. p.40. (In Russ.) ГОСТ 1.1-2002 Межгосударственная система стандартизации (МГСС). Термины и определения. Москва: Издательство стандартов, 2003. с.40. http://www.standards.ru/document/4162330.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit40"><label>40</label><citation-alternatives><mixed-citation xml:lang="ru">World Health Organization. Health impact assessment. https://www.who.int/health-topics/health-impact-assessment#tab=tab_1 (04 December 2020).</mixed-citation><mixed-citation xml:lang="en">World Health Organization. Health impact assessment. https://www.who.int/health-topics/health-impact-assessment#tab=tab_1 (04 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit41"><label>41</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ 33707-2016 (ISO/IEC 2382:2015) Информационные технологии (ИТ). Словарь. Москва: Стандартинформ, 2016. с.206. http://www.standards.ru/document/6257840.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST 33707-2016 (ISO/IEC 2382:2015) Information technologies. Vocabulary. Moscow: Standartinform, 2016. p.206. (In Russ.) http://www.standards.ru/document/6257840.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit42"><label>42</label><citation-alternatives><mixed-citation xml:lang="ru">Federal Law “On Information, Information Technology and Protection” of July 27, 2006 N 149-FZ. (In Russ.) Федеральный закон “Об информации, информационных технологиях и о защите информации” от 27.07.2006 N 149-ФЗ. http://www.consultant.ru/document/cons_doc_LAW_61798/ (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">Federal Law “On Information, Information Technology and Protection” of July 27, 2006 N 149-FZ. (In Russ.) http://www.consultant.ru/document/cons_doc_LAW_61798/ (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit43"><label>43</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ Р 51904-2002 Программное обеспечение встроенных систем. Общие требования к разработке и документированию. Москва: Стандартинформ, 2005. с. 67. http://www.standards.ru/document/4126971.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST R 51904-2002 Embedded system software. General requirements to development and documentation. Moscow: Standartinform, 2005. p.67. (In Russ.) http://www.standards.ru/document/4126971.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref><ref id="cit44"><label>44</label><citation-alternatives><mixed-citation xml:lang="ru">ГОСТ 1961974 Оборудование радиотелеметрическое. Термины и определения. Москва: Стандартинформ, 2005. с.20. http://www.standards.ru/document/4143727.aspx (08 December 2020).</mixed-citation><mixed-citation xml:lang="en">GOST 19619-74 Radiotelemetry equipment. Terms and definitions. Moscow: Standartinform, 2005. p.20. (In Russ.) http://www.standards.ru/document/4143727.aspx (08 December 2020).</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
