超声脂肪乳化仪器注册检测

助力超声脂肪乳化器产品合规，鉴证质量安全

可覆盖的检测服务范围有：安规、电磁兼容、生物学评价相关试验、包装运输、清洗消毒灭菌验证、临床前大动物试验等服务。

超声脂肪乳化仪注册检测

CTI华测检测可以为您提供【超声脂肪乳化仪】注册检测解决方案，可覆盖的检测服务范围有：安规、电磁兼容、生物学评价相关试验、包装运输、清洗消毒灭菌验证、临床前大动物试验等服务。

风险等级分类

根据《医疗器械分类目录》中的有源手术器械，管理类别为III类，产品分类编码为01 有源手术器械-01 超声手术设备及附件-01.2 超声手术设备。

超声脂肪乳化仪测试标准

国内注册-检测方案

项目说明	标准编号	标准名称
安规	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
安规	YY/T 9706.106-2021	医用电器设备第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
EMC	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
专用标准	YY/T 1750-2020	超声组织切割止血手术设备
专用标准	YY/T 0644-2008	超声外壳手术系统基本输出特性的测量和公布
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 16886.23-2023	医疗器械生物学评价第23部分：刺激试验
包装运输	GB/T 4857.5-1992	包装运输包装件跌落试验方法
	GB/T 4857.4-2008	包装运输包装件基本试验第4部分：采用压力试验机进行的抗压和堆码试验方法
	GB/T 4857.7-2005	包装运输包装件基本试验第7部分:正弦定频振动试验方法
清洗消毒验证	WS 310系列标准	医院消毒供应中心系列标准
	WS/T 367	医疗机构消毒技术规范
	YY/T 1495-2016	清洗消毒效果的微生物验证方法
	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2部分：低度危险性医疗器械
软件	YY/T 0664	医疗器械软件软件生存周期过程

国外注册-检测方案

项目说明	标准编号	标准名称
电气安全及性能标准	IEC 60601-1: 2005 + A1: 2012 + A2: 2020	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
	IEC 60601-1-6: 2010 + A1: 2013 + A2: 2020	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
	IEC 60601-1-11:2015+AMD1:2020	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
	IEC 60601-2-10:1987/A1:2001	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
	IEC 60601-2-40：2016	Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
EMC	IEC 60601-1-2: 2014 + A1: 2020	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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 10993-23:2021	Biological evaluation of medical devices — Part 23: Tests for irritation
包装运输	ASTM D 4169	Standard Practice for Performance Testing of Shipping Containers and Systems
清洗消毒验证	ANSI/AAMI ST98:2022	Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
	ASTM F3208-20	Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
	AAMI TIR 12-2020	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
软件	IEC 62304:2006+A1:2015	Medical device software - Software life cycle processes