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射频消融设备注册检测

认证资质：
检测价格：电议
检测周期：15-30天
检测类型：标准检测
送样方式：不限

领域分类：医疗器械-常规有源手术器械

检测项目：产品性能检测,专用标准测试,安规测试,清洗消毒灭菌验证,EMC测试

服务地点：全国

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详细信息

服务背景

CTI华测检测可以为您提供【射频消融设备】注册检测解决方案，可覆盖的检测服务范围有：安规和EMC、性能测试、生物学评价、清洗消毒灭菌验证等部分服务。

检测内容

射频消融设备注册检测

风险等级分类

根据《医疗器械分类目录》，射频消融设备和射频消融电极针均为三类医疗器械。射频消融设备的分类编码为01-03-02，射频消融电极针的分类编码为01-03-04。

射频消融设备测试标准

国内注册-检测方案

项目说明	标准编号	标准名称
安规、EMC和专用标准	GB 9706.1-2020	医用电气设备第1部分：基本安全和基本性能的通用要求
	YY 9706.102-2021	医用电气设备第1-2部分：基本安全和基本性能的通用要求并列标准：电磁兼容要求和试验
	YY 9706.106-2021	医用电气设备第1-6部分：基本安全和基本性能的通用要求并列标准：可用性
	YY 9706.108-2021	医用电气设备第1-8部分：基本安全和基本性能的通用要求并列标准：通用要求，医用电气设备和医用电气系统中报警系统的测试和指南
	GB 9706.202-2021	医用电气设备第2-2部分：高频手术设备及高频附件的基本安全和基本性能专用要求
	GB 4824-2019	工业、科学和医疗设备射频骚扰特性限值和测量方法
	YY 0650-2022	射频消融治疗设备通用技术要求
	YY/T 0776-2023	肝脏射频消融治疗设备
	YY 0778-2018	射频消融导管
	YY/T 1057-2016	医用脚踏开关通用技术条件
	GB/T 25000.51-2016	系统与软件工程系统与软件质量要求和评价(SQuaRE) 第51部分：就绪可用软件产品(RUSP)的质量要求和测试细则
	YY/T 0860-2024	心脏射频消融治疗设备
生物学评价	GB/T 16886.1-2022	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 16886.5-2017	医疗器械生物学评价第5部分：体外细胞毒性试验
	GB/T 16886.10-2024	医疗器械生物学评价第10部分：皮肤致敏试验
	GB/T 16886.11-2021	医疗器械生物学评价第11部分：全身毒性试验
	GB/T 16886.23-2023	医疗器械生物学评价第23部分：刺激试验
清洗消毒灭菌验证	WS/T 367-2012	医疗机构消毒技术规范
	WS 310系列	医院感染控制标准 / 清洗消毒及灭菌技术操作规范
	YY/T 0802.1-2024	医疗器械的处理医疗器械制造商提供的信息第1部分：中高度危险性医疗器械
	YY/T 0802.2-2024	医疗器械的处理医疗器械制造商提供的信息第1部分：低度危险性医疗器械
	GB/T 19973.1-2023	医疗保健产品灭菌微生物学方法第1部分:产品上微生物总数的确定
	GB/T 19973.2-2018	医疗产品灭菌微生物学方法第2部分：用于灭菌过程的定义、确认和维护的无菌试验
	GB 18278.1-2015	医疗保健产品灭菌　湿热　第1 部分：医疗器械灭菌过程的开发、确认和常规控制要求
	GB/T 19974-2018	医疗保健产品灭菌灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求
环境、软件和包装运输	YY/T 0664-2020	医疗器械软件软件生存周期过程
	GB/T 14710-2009	医用电器环境要求及试验方法
	GB/T 4857 系列	包装运输包装件基本试验

国外注册-检测方案

项目说明	标准编号	标准名称
安规、EMC和专业标准	IEC 60601-1-1:2014	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
	IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
	IEC 60601-1-6:2010	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
	IEC 60601-1-8:2006	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
	IEC 60601-2-2：2017	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
	CISPR 11:2015	Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
生物学评价	ISO 10993-1:2025	Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
	ISO 10993-5:2009	Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
	ISO 10993-10:2021	Biological evaluation of medical devices — Part 10: Tests for skin sensitization
	ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
	ISO 10993-23:2021	Biological evaluation of medical devices — Part 23: Tests for irritation
清洗消毒灭菌验证	AAMI TIR30:2011	A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
	ANSI/AAMI ST98:2022	Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
	AAMI TIR12:2020	Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
	ISO 17664-1:2021	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1: Critical and semi-critical medical devices
	ISO 17664-2:2021	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 2: Non-critical medical devices
	ISO 17665-1-2006	Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
	ISO 11737-1:2018	Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
	ISO 11737-2:2019	Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
加速老化	ASTM F1980-21	Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices