一次性使用精密过滤输液器的生物相容性研究
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摘要
目的:评价一次性使用精密过滤输液器的生物相容性,为其在临床上的安全应用提供依据。方法 :按照医疗器械生物学评价标准选择以下试验:细胞毒性试验采用MTT比色法;急性全身毒性试验、皮内反应试验和致敏试验分别以0.9%氯化钠注射液和棉籽油为浸提介质;血液相容性试验测定体外溶血率和凝血酶原时间;热原试验观察家兔体温升高情况。结果:该输液器的细胞毒性反应分级为1级;在氯化钠介质和棉籽油介质中,该输液器均无致敏反应、皮内反应、急性全身毒性反应;该输液器的溶血率为1.17%,凝血酶原时间所得结果与阴性对照和同类型产品对照比较,差异均无统计学意义。家兔体温升高总和为0.4℃。结论:一次性使用精密过滤输液器无细胞毒性、致敏反应、皮内反应、急性全身毒性反应、热原反应、溶血反应和凝血反应,具有良好的生物相容性,为其临床的安全应用提供了可靠保障。
Objective To study the biological compatibility of the disposable precise filtering infusion apparatus in order to provide evidence for the safety of clinical application. Methods According to biological evaluation criterion of medical devices, seven tests were selected in vitro and vivo. The cytotoxicity test was determined with MTT method in vitro; acute systemic toxicity test as well as the tests for irritation and sensitization were executed with sodium chloride injection and cottonseed oil as the leaching media; blood compatibility test detected hemolysis rate in vitro and prothrombin time; rabbit fervescence was measured during pyrogen test. Results The filtering infusion apparatus gained Grade 1 cytotoxicity, and had no sensitization response, intracutaneous reaction, acute systemic toxicity found during the tests. The hemolysis rate was 1.17%, and there were no statistical differences between the results of prothormbin time of the apparatus, negative control and like products. The rabbit had the body temperature increased by 0.4 ℃. Conclusion The disposable precise filtering infusion apparatus has no cytotoxicity, sensitization response, intracutaneous reaction, acute systemic toxicity, pyrogen reaction,hemolytic reaction and coagulation effect, and thus proves its high biocompatibility for clinical application. [Chinese Medical Equipment Journal,2019,40(5):38-42]
Objective To study the biological compatibility of the disposable precise filtering infusion apparatus in order to provide evidence for the safety of clinical application. Methods According to biological evaluation criterion of medical devices, seven tests were selected in vitro and vivo. The cytotoxicity test was determined with MTT method in vitro; acute systemic toxicity test as well as the tests for irritation and sensitization were executed with sodium chloride injection and cottonseed oil as the leaching media; blood compatibility test detected hemolysis rate in vitro and prothrombin time; rabbit fervescence was measured during pyrogen test. Results The filtering infusion apparatus gained Grade 1 cytotoxicity, and had no sensitization response, intracutaneous reaction, acute systemic toxicity found during the tests. The hemolysis rate was 1.17%, and there were no statistical differences between the results of prothormbin time of the apparatus, negative control and like products. The rabbit had the body temperature increased by 0.4 ℃. Conclusion The disposable precise filtering infusion apparatus has no cytotoxicity, sensitization response, intracutaneous reaction, acute systemic toxicity, pyrogen reaction,hemolytic reaction and coagulation effect, and thus proves its high biocompatibility for clinical application. [Chinese Medical Equipment Journal,2019,40(5):38-42]
引文
[1]张鹏,姜亚莉,朱雯希.一次性使用精密过滤输液器临床研究[J].中国卫生产业,2017,14(5):61-62.
[2]医疗器械生物学评价第1部分:风险管理过程中的评价与试验:GB/T 16886.1—2011[S].
[3]医疗器械生物学评价第12部分:样品制备与参照样品:GB/T 16886.12—2017[S].
[4]张磊,叶小惠,章亚兵,等.骨外固定支架材料的生物学评价[J].医疗卫生装备,2018,39(1):23-26.
[5]医用输液、输血、注射器具检验方法第2部分:生物学试验方法:GB/T 14233.2—2005[S].
[6]医疗器械生物学评价第10部分:刺激与迟发型超敏反应试验:GB/T 16886.10—2017[S].
[7]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:附录153-154.
[8]医疗器械生物学评价第4部分:与血液相互作用试验选择:GB/T 16886.4—2003[S].
[9] LANINA S Y,SUSLOVA V J,BENYAEV N E. Toxicological and biological safety of medical devices[J]. Biomed Eng,2012,46(3):120-123.
[10]刘西玲,吉林祝,杨晰.精密输液器与普通输液器安全性能比较[J].护理研究,2016,30(14):1 765-1 767.
[11]张晓红,吴玉芬.一次性使用精密过滤袋式输液器在普外科的应用效果评价[J].实用医院临床杂志,2017,14(1):109-110.
[12]蒋海英,张洁.儿科护理人员一次性精密过滤输液器的使用现状调查[J].医疗装备,2014,27(12):141-142.
[13] GOV Y,BITLER A,DELLACQUA G,et al. RNAIII inhibiting peptide(RIP),a global inhibitor of Staphylococcus aureus pathogenesis:structure and function analysis[J]. Peptides,2001,22(10):1 609-1 620.
[14]季顺锋.一次性使用滴定管式输液器辐照灭菌后组织生物相容性系统评介试验[D].苏州:苏州大学,2013.
[15]由少华.医疗器械血液相容性评价与试验[J].中国医疗器械信息,2006,34(12):49-54.
[2]医疗器械生物学评价第1部分:风险管理过程中的评价与试验:GB/T 16886.1—2011[S].
[3]医疗器械生物学评价第12部分:样品制备与参照样品:GB/T 16886.12—2017[S].
[4]张磊,叶小惠,章亚兵,等.骨外固定支架材料的生物学评价[J].医疗卫生装备,2018,39(1):23-26.
[5]医用输液、输血、注射器具检验方法第2部分:生物学试验方法:GB/T 14233.2—2005[S].
[6]医疗器械生物学评价第10部分:刺激与迟发型超敏反应试验:GB/T 16886.10—2017[S].
[7]国家药典委员会.中华人民共和国药典(四部)[M].北京:中国医药科技出版社,2015:附录153-154.
[8]医疗器械生物学评价第4部分:与血液相互作用试验选择:GB/T 16886.4—2003[S].
[9] LANINA S Y,SUSLOVA V J,BENYAEV N E. Toxicological and biological safety of medical devices[J]. Biomed Eng,2012,46(3):120-123.
[10]刘西玲,吉林祝,杨晰.精密输液器与普通输液器安全性能比较[J].护理研究,2016,30(14):1 765-1 767.
[11]张晓红,吴玉芬.一次性使用精密过滤袋式输液器在普外科的应用效果评价[J].实用医院临床杂志,2017,14(1):109-110.
[12]蒋海英,张洁.儿科护理人员一次性精密过滤输液器的使用现状调查[J].医疗装备,2014,27(12):141-142.
[13] GOV Y,BITLER A,DELLACQUA G,et al. RNAIII inhibiting peptide(RIP),a global inhibitor of Staphylococcus aureus pathogenesis:structure and function analysis[J]. Peptides,2001,22(10):1 609-1 620.
[14]季顺锋.一次性使用滴定管式输液器辐照灭菌后组织生物相容性系统评介试验[D].苏州:苏州大学,2013.
[15]由少华.医疗器械血液相容性评价与试验[J].中国医疗器械信息,2006,34(12):49-54.