Article(id=1320381073155015209, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320381045866873144, articleNumber=null, orderNo=null, doi=10.11876/mimt202601007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1792732979334, onlineDateStr=2026-10-23, pubDate=1770652800000, pubDateStr=2026-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792732979334, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792732979334, creator=13701087609, updateTime=1792732979334, updator=13701087609, issue=Issue{id=1320381045866873144, tenantId=1146029695717560320, journalId=1319373289681944729, year='2026', volume='32', issue='1', pageStart='1', pageEnd='106', issueExtLink='null', onlineDate='null', pubDate='1770652800000', pubDateStr='2026-02-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792732972828, creator='13701087609', updateTime=1792746352003, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437162382840024, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320381045866873144, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437162382840025, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320381045866873144, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=48, endPage=53, ext={EN=ArticleExt(id=1320381073360536106, articleId=1320381073155015209, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=Effects of different extraction methods and detection standards on cytotoxicity test results of disposable infusion sets, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective This study aims to systematically compare the differences in cytotoxicity evaluation of disposable infusion sets between the weight-based and inner surface area-based extraction methods, as well as between the two standards GB/T 16886.5—2017 and GB/T 14233.2—2005. The goal is to establish an extraction protocol that more accurately reflects the clinical biological safety risk characteristics.
Methods A clinically standard disposable infusion set was selected as the research object. Based on the two standards, two extraction solutions were prepared. ①Weight-based method: 0.2 g/mL of the cut material added to MEM medium containing serum; ②Inner surface area method: 6 cm2/mL of MEM medium containing serum filled into the lumen of the infusion set. Both were extracted under shaking conditions (37 ℃, 60 rpm) for 72 hours. The extracts were then subjected to comparative in vitro cytotoxicity testing.
Results Qualitative results indicated that cytotoxic responses varied under different standards. According to GB/T 16886.5—2017, the 100% extracts from both extraction methods exhibited mild cytotoxicity (Grade 2), whereas under GB/T 14233.2—2005, they both showed moderate cytotoxicity (Grade 3). Quantitative results revealed that, regardless of the standard used, the inner surface area extraction method consistently yielded higher cytotoxicity than the weight-based method. Notably, under GB/T 16886.5—2017, a significant difference in cell viability was observed between the two extraction methods (P<0.001).
Conclusion For lumen-type devices such as infusion sets, employing the inner surface area extraction method in strict accordance with GB/T 16886.5 provides a more realistic reflection of clinical biological safety risks. It is also crucial to recognize methodological differences between standards. The more sensitive GB/T 14233.2 is recommended for risk screening during product release and batch consistency monitoring. Conversely, for medical device registration review and systemic biological evaluation, a comprehensive assessment strategy based on the inner surface area extraction within the GB/T 16886.5 framework should be prioritized.
, authors=Ge Ding, Chunhua Guo, Juan Zhang, Qing Wen, Bo Liu, Xue Wang, authorsList=Ge Ding, Chunhua Guo, Juan Zhang, Qing Wen, Bo Liu, Xue Wang, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=
All copyrights in 2026 belong to the sponsor of the journal.Not content published by the journal may be reproduced or abridged without authorization., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320381073645748779, articleId=1320381073155015209, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=不同浸提方式与检测标准对一次性输液器细胞毒性检测结果的影响, columnId=1320381056239387017, journalTitle=现代仪器与医疗, columnName=医学工程, runingTitle=null, highlight=null, articleAbstract=
目的 系统比较克重法与内表面积法两种浸提方式和GB/T 16886.5—2017与GB/T 14233.2—2005两项标准在一次性输液器细胞毒性评价中的差异性，旨在建立一种更符合临床生物安全风险特征的浸提方案。
方法 选取临床常规使用的一次性输液器作为研究对象，依据GB/T 16886.5—2017和GB/T 14233.2—2005，设计两种浸提液制备方案。①克重法：将裁剪后的材料按0.2 g/mL的比例加入含血清的MEM培养基；②内表面积法：将含血清的MEM培养基按6 cm2/mL的比例灌注至输液器腔内。两者均于37 ℃、60 rpm的振荡条件下浸提72 h。取浸提液进行体外细胞毒性对比测试。
结果 定性结果提示，不同检测标准下细胞毒性反应存在差异，依据GB/T 16886.5—2017，两种浸提方式的100%浸提液均呈轻度细胞毒性（2级）；而依据GB/T 14233.2—2005，则均呈中度细胞毒性（3级）。定量结果提示，无论在何种标准下，采用内表面积浸提法所测得的细胞毒性均高于克重浸提法，尤其在GB/T 16886.5—2017标准下，两种浸提方式的细胞存活率存在显著差异（P<0.001）。
结论 对于输液器等管腔类器械，采用内表面积法的浸提方式并严格依照GB/T 16886.5进行评价，能够更真实地反映其临床生物安全风险。同时，应重视不同标准在方法学上的差异，建议在产品放行与批次一致性监控等质量控制环节，参考灵敏度更高的GB/T 14233.2进行风险筛查；而在医疗器械注册审评与系统生物学评价中，则优先采用GB/T 16886.5标准下基于内表面积浸提法的综合评价策略。
, authors=丁鸽, 郭春花, 张娟, 温晴, 刘博, 王雪, authorsList=丁鸽, 郭春花, 张娟, 温晴, 刘博, 王雪, authorCompany=null, correspAuthors=null, authorNote=
丁鸽，女，本科，主管药师，研究方向：医疗器械生物学评价
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2026年版权归本刊主办单位所有未经本刊书面许可, 不得转载、摘编本刊所有文章内容。, copyrightOwner=中国科学器材公司, extLink=null, articleAbsUrl=null, sourceXml=NGLQSpVZyoaFTyOncgHu0w==, magXml=ppYA8JZ3+I+UUrI1Dg90OA==, pdfUrl=null, pdf=xnYePDqB/v86Mfhh/WYuEQ==, pdfFileSize=2242703, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=W227YxZDBlMr3pUyX/3vzw==, mapNumber=null, fund=null)}, authors=[Author(id=1320381074052596272, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320381073155015209, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1320381074149065266, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320381073155015209, authorId=1320381074052596272, language=EN, stringName=Ge Ding, firstName=Ge, middleName=null, lastName=Ding, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Safety Evaluation Center, Shaanxi Medical Device Quality Inspection Institute, Xi'an 712000, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1320381074211979827, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320381073155015209, authorId=1320381074052596272, language=CN, stringName=丁鸽, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=陕西省医疗器械质量检验院安全评价中心，西安 712000, bio={"content":"
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