Comparative analysis of the Latest and Old Versions of the International Standard of Active Implantable Medical Devices Named ISO14708-1

doi:10.16153/j.1002-7777.2021.11.002

Chinese Pharmaceutical Affairs ›› 2021, Vol. 35 ›› Issue (11) : 1213-1219. DOI: 10.16153/j.1002-7777.2021.11.002

Fu Li, Chen Tiantian, Shi Yanping, Jiang Shuo, Yu Zhe, Zhang Ke, Tan Feifei

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Abstract

Objective: The latest version standard of active implantable medical devices (AIMDs) named ISO 14708-1:2014 were explored to provide references for developers and supervisors. Methods: The differences between ISO 14708-1:2014 and the old version of ISO 14708-1:2000 were compared and analyzed combining daily work. Results: ISO 14708-1:2014 made technical revisions on a large number of clauses, which proposed new requirements for AIMDs. Conclusion: The latest edition of the standard provides more rigorous and detailed requirements and testing methods for the detection of active implantable medical devices, which are of great significance to adapt to the rapid development of active implantable medical device industry under the new situation.

Key words

active implantable medical devices； ISO14708-1:2014； ISO 14708-1:2000； differences； conversion； miscellaneous medical treatment

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Fu Li, Chen Tiantian, Shi Yanping, Jiang Shuo, Yu Zhe, Zhang Ke, Tan Feifei. Comparative analysis of the Latest and Old Versions of the International Standard of Active Implantable Medical Devices Named ISO14708-1[J]. Chinese Pharmaceutical Affairs, 2021, 35(11): 1213-1219 https://doi.org/10.16153/j.1002-7777.2021.11.002

References

[1] 李澍,郝烨,王权,等.有源植入医疗器械核磁共振成像安全性评价方法研究[J].中国药事,2019,33(10):1109-1115.
[2] 刘毅,孟志平.高风险有源植入式医疗器械标准要求及异同分析[J].医疗装备,2015(1):5-8.
[3] Kuang Ronny Jd,Pirakalathanan Janu,Lau Theodore,et al.An Up-to-date Review of Cardiac Pacemakers and Implantable Cardioverter Defibrillators[J].Journal of Medical Imaging and Radiation Oncology,2021,doi:10.1111/1754-9485.13319.
[4] 褚松筠,王玉玲,蒋捷,等.起搏器患者进行磁共振检查的安全性研究[J].临床心血管病杂志,2020,36(11):1008-1012.
[5] 王伟明,李路明,李青峰,等.植入式神经刺激器国际标准2017版解读[J].中国医疗器械杂志,2018,42(2):133-136.
[6] 方萍,俞彩芹.儿童人工耳蜗植入后听觉言语能力恢复效果及影响因素分析[J].中国妇幼保健,2020,35(21):3990-3993.
[7] 赵晓云,胡健,徐百成,等.人工耳蜗植入相关进展[J].中华耳科学杂志,2020,18(6):1113-1118.
[8] 李娜,孟志平.有源植入物与磁共振成像射频场兼容性测试系统的构建[J].医疗装备,2020,33(9):428-433.
[9] 倪萍,陈自谦.体内植入物患者磁共振扫描的安全策略 [J].中国医学影像技术,2020,26(增刊1):428-433.
[10] 陈甜甜,付丽,于晓慧,等.有源植入式医疗器械标准研究[J].医疗卫生装备,2021,42(3):74-76,101.
[11] The International Organization for Standardization(ISO).ISO 14708-1:2000,Implants for Aurgery — Active Implantable Medical Devices — Part 1:General Requirements for Safety,Marking and for Information to Be Provided by theManufacturer[S].2000.
[12] 中华人民共和国国家质量监督检验检疫总局,中国国家标准化管理委员会.GB 16174.1-2015,手术植入物有源植入式医疗器械第1部分:安全、标记和制造商所提供信息的通用要求[S].2015.
[13] The International Organization for Standardization(ISO).ISO14708-1:2014,ISO 14708-1:2014 Implants for Surgery — Active Implantable Medical Devices — Part 1:General Requirements for Safety,Marking and for Information to Be Provided by the Manufacturer[S].2014.
[14] 李永华,王晶,张尉强,等.ISO/TS 10974《患者携带有源植入物接受磁共振成像的安全评估规范》第二版与第一版的比较研究[J].中国医疗器械杂志,2021,45(1):90-95,104.
[15] 高中,张尉强,陈信元.有源植入式医疗器械在动车组环境下的电磁干扰风险研究[J].中国医疗器械杂志,2020,44(4):302-306.
[16] Aissani Sarra,Laistler Elmar,Felblinger Jacques.MR Safety Assessment of Active Implantable Medical Devices[J].Der Radiologe,2019,59(1):40-45.
[17] Wang Z,Zheng J,Wang Y,et al.On the Model Validation of Active Implantable Medical Device for MRI Safety Assessment[J].IEEE Trans Microw Theory Tech,2019,68(6):2234-2242.
[18] The International Electrotechnical Commission(IEC).IEC60601-1:2005+A1:2012,Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential Performance[S].2012.
[19] 于晓慧,李庆雨,宋庆华,等.浅析IEC61010-1第三版转化对我国体外诊断设备的影响[J].中国医疗器械信息,2018,24(15):1-2,54.
[20] 李铖铃,邬小玫.MRI射频场环境下植入物佩戴者的安全性研究[J].中国医疗器械杂志,2020,44(2):428-433.
[21] The International Organization for Standardization(ISO).ISO10974-2018,Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device[S].2018.
[22] 张争辉,胡天宙,温莉茵,等.医疗器械射频致热测试的研究[J].中国药事,2021,35(3):323-328.