注射泵注册检测

助力注射泵产品合规，鉴证质量安全

可覆盖的检测服务范围有：产品电气安全、电磁兼容、生物学评价、清洗消毒灭菌验证、医疗器械包装验证、包装运输等服务。

注射泵注册检测

CTI华测检测可以为您提供注射泵注册检测解决方案，可覆盖的检测服务范围有：产品电气安全、电磁兼容、生物学评价、清洗消毒灭菌验证、医疗器械包装验证、包装运输等服务。

风险等级分类

根据《医疗器械分类目录》，注射泵的风险等级管理类别为Ⅱ类，产品分类编码为14注输、护理和防护器械-01注射、穿刺器械-01注射泵。

注射泵测试标准

国内注册-检测方案

项目说明	标准编号	标准名称
电气安全	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/T 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
	GB/T 14710-2009	医用电气环境要求及试验方法
	YY/T 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
	YY 0709-2009	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
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
EMC	GB/T 18268.1-2025	测量、控制和实验室用的电设备电磁兼容性要求第1部分：通用要求
医疗器械软件	YY/T 0664-2020	医疗器械软件软件生存周期过程
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 16886.12-2023	医疗器械生物学评价第12部分：样品制备与参照材料
	GB/T 16886.23-2023	医疗器械生物学评价第23部分：刺激试验
清洗消毒验证	WS 310系列	医院消毒供应中心系列规范
	WS/T 367-2012	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 1623-2018	可重复使用医疗器械灭菌过程有效性的试验方法
	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2部分：低度危险性医疗器械
医疗器械包装验证	YY/T 0681.1-2018	无菌医疗器械包装试验方法第1部分:加速老化试验指南
	GB/T 19633.1-2015	最终灭菌医疗器械包装第1 部分:材料、无菌屏障系统和包装系统的要求
	YY/T 0681系列标准	无菌医疗器械包装试验方法
	GB/T 19633.1-2015	最终灭菌医疗器械包装-材料、无菌屏障系统和包装系统的要求
	GB/T 19633.2-2015	最终灭菌医疗器械包装-成型、密封和装配过程的确认的要求
包装运输	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

国外注册-检测方案

项目说明	标准编号	标准名称
电气安全	IEC60601-1:2005 +A1:2012 + A2:2020	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
	IEC60601-1-6:2010+ A1:2013 + A2: 2020	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
	IEC 60601-1- 8:2006+A2:2020	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 60601-1- 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
EMC	IEC 61326-1:2020	Electrical equipment for measurement, control and laboratory use -EMC requirements - Part 1: General requirements
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
医疗器械软件	IEC 62304:2006+A1:2015	Medical device software - Software life cycle processes
	EN 62304:2006+A1:2015	Medical device software - Software life cycle processes
	BS EN 62304:2006+A1:2015	Medical device software - Software life cycle processes
生物学评价	ISO 10993-1:2018	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 10993-12:2021	Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
	ISO 10993-23:2021	Biological evaluation of medical devices — Part 23: Tests for irritation
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
	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
医疗器械包装验证	ASTM F1980-2016	Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
	ISO 11607-1:2019	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
	ISO 11607-2:2019	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
	DIN 58953-6:2025-03	Sterilisation - Sterilgutversorgung - Teil 6: Prüfung der Keimdichtigkeit von Verpackungsmaterialien für zu sterilisierende Medizinprodukte
包装运输	ASTM D 4169	Standard Practice for Performance Testing of Shipping Containers and Systems