Article(id=1320389020694204803, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, articleNumber=null, orderNo=null, doi=10.11876/mimt202505007, 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=1792734874175, onlineDateStr=2026-10-23, pubDate=1760025600000, pubDateStr=2025-10-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792734874175, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792734874175, creator=13701087609, updateTime=1792734874175, updator=13701087609, issue=Issue{id=1320388968923902012, tenantId=1146029695717560320, journalId=1319373289681944729, year='2025', volume='31', issue='5', pageStart='1', pageEnd='108', issueExtLink='null', onlineDate='null', pubDate='1760025600000', pubDateStr='2025-10-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792734861832, creator='13701087609', updateTime=1792746392297, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437331253900271, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437331253900272, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=48, endPage=52, ext={EN=ArticleExt(id=1320389020857782660, articleId=1320389020694204803, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=Performance quality control testing and analysis of ventilators, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the performance of 450 ventilators in use in Zhejiang Province by systematically assessing the pass rates of core parameters across different brands and analyzing the correlation between service life and performance, thereby providing evidence for precise quality control and scientific maintenance.

Methods

In accordance with GB 9706.212—2020 and JJF 1234—2018, five key parameters (tidal volume, mandatory ventilation frequency, FiO2, inspiratory pressure level, and PEEP) were tested using a Fluke VT650 gas flow analyzer. Descriptive statistics and Spearman rank correlation analysis were employed for systematic comparison and correlation analysis from the dimensions of brand type and service life.

Results

The overall pass rate of the 450 ventilators was 58.67% (264/450). Significant disparities were observed in the pass rates of core parameters among brands: Imported Brand 2 had the highest overall pass rate (70.48%), while Domestic Brand 2 had the lowest (0.00%). Tidal volume exhibited the most notable variation in pass rates among brands (0%~90.75%), identified as the primary weakness of domestic devices. Correlation analysis between service life and performance revealed that Imported Brand 2 maintained stable performance with no significant correlation to service life (ρ=-0.094, P=0.157). In contrast, Imported Brand 1 (ρ=-0.382, P=0.001) and Imported Brand 3 (ρ=-0.446, P<0.001) showed significant negative correlations, while Domestic Brand 1 also demonstrated a weak negative correlation (ρ=-0.215, P=0.035).

Conclusion

The current overall performance of ventilators requires improvement, with tidal volume accuracy being a common technical bottleneck for domestic devices. Furthermore, performance degradation patterns over time vary significantly by brand. It is recommended to establish a differentiated quality control system focusing on tidal volume, incorporating service life and brand-specific characteristics, to enhance the clinical safety and whole-life-cycle management of ventilators.

, authors=Ji Zhang, Jianwei Qi*, authorsList=Ji Zhang, Jianwei Qi, authorCompany=null, correspAuthors=Jianwei Qi, authorNote=null, correspAuthorsNote=null, copyrightStatement=All copyrights in 2025 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=1320389021591785861, articleId=1320389020694204803, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=呼吸机性能质量控制检测与分析, columnId=1320381056239387017, journalTitle=现代仪器与医疗, columnName=医学工程, runingTitle=null, highlight=null, articleAbstract=
目的

通过对浙江省13家哨点医院450台在用呼吸机的性能进行检测与分析,量化评估不同品牌、不同使用年限设备的综合性能,明确国产与进口呼吸机的关键技术差距,为临床精准质控与设备科学维护提供数据支持。

方法

依据GB 9706.212—2020《医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求》和JJF 1234—2018《呼吸机校准规范》,使用Fluke VT650气体流量分析仪对潮气量、强制通气频率、吸气氧浓度、吸气压力水平及呼气末正压5项关键参数进行检测;采用描述性统计和斯皮尔曼等级相关分析,从品牌类型和使用年限两个维度进行系统性比较与关联分析。

结果

450台呼吸机整体检测通过率为58.67%(264/450)。各品牌核心性能指标通过率差异显著:进口品牌2整体检测通过率最高(70.48%),国产品牌2最低(0.00%);潮气量通过率品牌间差异最为突出(0%~90.75%),为国产品牌主要短板。使用年限与性能表现关联性分析显示:进口品牌2性能稳定,与使用年限无相关性(ρ=-0.094,P=0.157);进口品牌1与进口品牌3的检测通过率与使用年限呈负相关(ρ=-0.382,P=0.001;ρ=-0.446,P<0.001);国产品牌1亦呈负相关(ρ=-0.215,P=0.035)。

结论

当前呼吸机整体性能状况有待提升,潮气量精度为国产设备共性技术瓶颈,且设备性能随使用年限的衰减规律存在明显品牌差异。建议建立以潮气量为核心、结合使用年限与品牌特性的差异化质控体系,提升呼吸机临床应用安全性与全生命周期管理水平。

, authors=张吉, 祁建伟*, authorsList=张吉, 祁建伟, authorCompany=null, correspAuthors=祁建伟, authorNote=

张吉,男,本科,工程师,研究方向:医疗设备质量控制

, correspAuthorsNote=
祁建伟,男,硕士研究生,高级工程师,研究方向:医疗设备质量控制
, copyrightStatement=2025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=ZnrRLaQXMkB2AqJH+8sOgA==, magXml=UWvDtwkS/1TxVU1gdFfdyA==, pdfUrl=null, pdf=T553zV2CVzHCVC89AqS70Q==, pdfFileSize=1854657, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=2R3xt3D2ds+KR6LBN2aArQ==, mapNumber=null, fund=null)}, authors=[Author(id=1320389022971711882, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389020694204803, 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=1320389023047209356, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389020694204803, authorId=1320389022971711882, language=EN, stringName=Ji Zhang, firstName=Ji, middleName=null, lastName=Zhang, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Zhejiang Hospital, Hangzhou 310013, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1320389023114318221, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389020694204803, authorId=1320389022971711882, language=CN, stringName=张吉, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=浙江医院,杭州 310013, bio={"content":"

张吉,男,本科,工程师,研究方向:医疗设备质量控制

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张吉 , 祁建伟 *
现代仪器与医疗 | 医学工程 2025,31(5): 48-52
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现代仪器与医疗 |医学工程 2025 , 31 (5) : 48 -52
呼吸机性能质量控制检测与分析
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张吉, 祁建伟*
作者信息
  • 浙江医院,杭州 310013
通讯作者:
祁建伟,男,硕士研究生,高级工程师,研究方向:医疗设备质量控制
作者简介:

张吉,男,本科,工程师,研究方向:医疗设备质量控制

Performance quality control testing and analysis of ventilators
Ji Zhang, Jianwei Qi*
Affiliations
  • Zhejiang Hospital, Hangzhou 310013, China
出版时间: 2025-10-10 doi: 10.11876/mimt202505007
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目的

通过对浙江省13家哨点医院450台在用呼吸机的性能进行检测与分析,量化评估不同品牌、不同使用年限设备的综合性能,明确国产与进口呼吸机的关键技术差距,为临床精准质控与设备科学维护提供数据支持。

方法

依据GB 9706.212—2020《医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求》和JJF 1234—2018《呼吸机校准规范》,使用Fluke VT650气体流量分析仪对潮气量、强制通气频率、吸气氧浓度、吸气压力水平及呼气末正压5项关键参数进行检测;采用描述性统计和斯皮尔曼等级相关分析,从品牌类型和使用年限两个维度进行系统性比较与关联分析。

结果

450台呼吸机整体检测通过率为58.67%(264/450)。各品牌核心性能指标通过率差异显著:进口品牌2整体检测通过率最高(70.48%),国产品牌2最低(0.00%);潮气量通过率品牌间差异最为突出(0%~90.75%),为国产品牌主要短板。使用年限与性能表现关联性分析显示:进口品牌2性能稳定,与使用年限无相关性(ρ=-0.094,P=0.157);进口品牌1与进口品牌3的检测通过率与使用年限呈负相关(ρ=-0.382,P=0.001;ρ=-0.446,P<0.001);国产品牌1亦呈负相关(ρ=-0.215,P=0.035)。

结论

当前呼吸机整体性能状况有待提升,潮气量精度为国产设备共性技术瓶颈,且设备性能随使用年限的衰减规律存在明显品牌差异。建议建立以潮气量为核心、结合使用年限与品牌特性的差异化质控体系,提升呼吸机临床应用安全性与全生命周期管理水平。

呼吸机  /  质量控制  /  统计分析  /  使用年限  /  潮气量
Objective

To evaluate the performance of 450 ventilators in use in Zhejiang Province by systematically assessing the pass rates of core parameters across different brands and analyzing the correlation between service life and performance, thereby providing evidence for precise quality control and scientific maintenance.

Methods

In accordance with GB 9706.212—2020 and JJF 1234—2018, five key parameters (tidal volume, mandatory ventilation frequency, FiO2, inspiratory pressure level, and PEEP) were tested using a Fluke VT650 gas flow analyzer. Descriptive statistics and Spearman rank correlation analysis were employed for systematic comparison and correlation analysis from the dimensions of brand type and service life.

Results

The overall pass rate of the 450 ventilators was 58.67% (264/450). Significant disparities were observed in the pass rates of core parameters among brands: Imported Brand 2 had the highest overall pass rate (70.48%), while Domestic Brand 2 had the lowest (0.00%). Tidal volume exhibited the most notable variation in pass rates among brands (0%~90.75%), identified as the primary weakness of domestic devices. Correlation analysis between service life and performance revealed that Imported Brand 2 maintained stable performance with no significant correlation to service life (ρ=-0.094, P=0.157). In contrast, Imported Brand 1 (ρ=-0.382, P=0.001) and Imported Brand 3 (ρ=-0.446, P<0.001) showed significant negative correlations, while Domestic Brand 1 also demonstrated a weak negative correlation (ρ=-0.215, P=0.035).

Conclusion

The current overall performance of ventilators requires improvement, with tidal volume accuracy being a common technical bottleneck for domestic devices. Furthermore, performance degradation patterns over time vary significantly by brand. It is recommended to establish a differentiated quality control system focusing on tidal volume, incorporating service life and brand-specific characteristics, to enhance the clinical safety and whole-life-cycle management of ventilators.

Ventilator  /  Quality control  /  Statistical analysis  /  Service years  /  Tidal volume
张吉, 祁建伟. 呼吸机性能质量控制检测与分析. 现代仪器与医疗, 2025 , 31 (5) : 48 -52 . DOI: 10.11876/mimt202505007
Ji Zhang, Jianwei Qi. Performance quality control testing and analysis of ventilators[J]. Modern Instruments & Medical Treatment, 2025 , 31 (5) : 48 -52 . DOI: 10.11876/mimt202505007
  • 国家重点研发计划(2017YFC0114107)
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doi: 10.11876/mimt202505007
  • 首发时间:2026-10-23
  • 出版时间:2025-10-10
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国家重点研发计划(2017YFC0114107)
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    浙江医院,杭州 310013

通讯作者:

祁建伟,男,硕士研究生,高级工程师,研究方向:医疗设备质量控制
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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