根据美国医疗器械促进协会/欧洲高血压学会/国际标准化组织（ISO 81060-2:2018）+AMD1:2020标准，验证欧姆龙J760电子血压计在普通人群中的准确性。
Validating the accuracy of Omron J760 electronic blood pressure monitor in the general population according to AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020.
作者信息
Chen Bihua, Chen Guorong, Jiang Hong, Sun Ya, Chen Jie, Wang Dan, Chen Mingzhi, Shi Jia, Peng Yan, Cheng Yimin, Yang Cheng, Ding Yuanyuan, Su Jin, Liu Ming, Shen Fulai, Qiu Yicheng, Shen Yi, Cao Qiyun, Su Jiayu
机构信息
Administrative Office, Shanghai Xuhui District Fenglin Community Health Service Center, Shanghai, China.
Department of Medical Affairs, Shanghai Xuhui District Fenglin Community Health Service Center, Shanghai, China.
出版信息
Blood Press. 2025 Dec;34(1):2469264. doi: 10.1080/08037051.2025.2469264. Epub 2025 Feb 25.
PURPOSE
The accuracy of the Omron J760 electronic blood pressure (BP) monitor for upper arm BP measurement in the adult general population was validated following the AAMI/ESH/ISO (ISO 81060-2:2018) + Amd1:2020 protocol. We expect that this device can be used for home blood pressure monitoring, with its measurements serving as a clinical reference.
METHODS
Subjects meeting the age, gender, BP, and cuff distribution criteria as specified by the AAMI/ESH/ISO (ISO 81060-2:2018) + Amd1:2020 were recruited. BP measurements were conducted using the same-arm sequential method. The test device cuff was suitable for arm circumferences ranging from 22.0 cm to 42.0 cm.
RESULTS
Eighty-nine participants were initially recruited, 85 were evaluated after excluding 4 participants. The mean age of the participants was 48.5 ± 15.17 years. For validation criterion 1, the mean ± standard deviation (SD) of the differences between the test device and the reference BP measurements were 0.2 ± 5.74 mmHg for systolic BP and -0.9 ± 4.69 mmHg for diastolic BP. These results met the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd1:2020 standard, which requires differences of ≤5 ± ≤8 mmHg. For validation criterion 2, the mean differences between the test device and the reference device were 0.2 ± 5.10 mmHg for systolic BP and -0.9 ± 4.30 mmHg for diastolic BP. This criterion was satisfied with criterion 2 of ≤6.95 mmHg for systolic BP and ≤6.88 mmHg for diastolic BP.
CONCLUSION
The Omron J760 electronic BP monitor meets the requirements of the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd 1:2020 validation standard.
目的
按照美国医疗器械促进协会（AAMI）/欧洲高血压学会（ESH）/国际标准化组织（ISO）（ISO 81060 - 2:2018）+修订版1:2020的方案，对欧姆龙J760电子血压计在上臂血压测量方面用于成年普通人群的准确性进行验证。我们期望该设备可用于家庭血压监测，其测量结果可作为临床参考。
方法
招募符合AAMI/ESH/ISO（ISO 81060 - 2:2018）+修订版1:2020所规定的年龄、性别、血压及袖带适配标准的受试者。采用同侧连续测量法进行血压测量。测试设备的袖带适用于臂围为22.0厘米至42.0厘米的人群。
结果
最初招募了89名参与者，排除4名参与者后，对85名进行了评估。参与者的平均年龄为48.5 ± 15.17岁。对于验证标准1，测试设备与参考血压测量值之间收缩压差值的均值 ± 标准差（SD）为0.2 ± 5.74 mmHg，舒张压差值为 -0.9 ± 4.69 mmHg。这些结果符合AAMI/ESH/ISO（ISO 81060 - 2:2018）+修订版1:2020的标准，该标准要求差值≤5 ± ≤8 mmHg。对于验证标准2，测试设备与参考设备之间收缩压的平均差值为0.2 ± 5.10 mmHg，舒张压为 -0.9 ± 4.30 mmHg。收缩压≤6.95 mmHg且舒张压≤6.88 mmHg的标准2也得到了满足。
结论
欧姆龙J760电子血压计符合AAMI/ESH/ISO（ISO 81060 - 2:2018）+修订版1:2020验证标准的要求。
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