喉镜用窥视片注册检测

助力喉镜用窥视片产品合规，鉴证质量安全

可覆盖的检测服务范围有：性能测试，生物学评价，包装验证，清洗消毒灭菌验证，无菌检测等服务。

喉镜用窥视片注册检测

CTI华测检测可以为您提供【麻醉咽喉镜附件】注册检测解决方案，可覆盖的检测服务范围有：性能测试，生物学评价，包装验证，清洗消毒灭菌验证，无菌检测等服务。

风险等级分类

根据《医疗器械分类目录》中的分类，喉镜用窥视片属于麻醉咽喉镜附件，管理类别为II类，产品分类编码为08呼吸、麻醉与急救器械--05 呼吸、麻醉、急救设备辅助装置--06 气管插管用喉镜。

喉镜用窥视片测试标准

国内注册-检测方案

项目说明	标准编号	标准名称
性能指标	YY 0499—2023	麻醉和呼吸设备气管插管用喉镜
	YY 0498.1—2004	喉镜连接件第1部分：常规挂钩型手柄-窥视片接头
	YY 0498.2—2004	喉镜连接件第2部分：微型电灯螺纹和带常规窥视片的灯座
	YY/T 0149—2006	不锈钢医疗器械耐腐蚀性能试验方法
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
清洗消毒灭菌验证	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
	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
	GB 18278.1-2015	医疗保健产品灭菌热湿第 1 部分:医疗器械灭菌过程的开发、确认和常规控制要求
	GB 18280.2-2015	医疗保健产品灭菌辐射第 2 部分：建立灭菌剂量
	GB/T 16886.7-2015	医疗器械生物学评价第7部分：环氧乙烷灭菌残留量
无菌检测	GB/T 19973.2-2025	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
无菌检测	中国药典 2025 年版四部通则 1101 无菌检查法
医疗器械包装验证	YY 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
	YY/T 0681系列	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
	YY/T 0681.15-2019	无菌医疗器械包装试验方法第15部分：运输容器和系统的性能试验
	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
性能指标	ISO 7376:2020	Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation
性能指标	ISO 13402:1995	Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
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 10993-23:2021	Biological evaluation of medical devices — Part 23: Tests for irritation.
清洗消毒灭菌验证	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 17665:2024	Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
	ISO 11137-2: 2013	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
	ISO 25424-2018	Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices – Amendment
	AAMI ST79:2017 10	Comprehensive guide to steam sterilization and sterility assurance in health care facilities
	ISO 14937:2009	Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
	ISO 22441-2022	Sterilization of health care products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
	ISO 10993-7:2008	Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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 2: Validation requirements for forming, sealing and assembly processes
	ASTM D4169-23el	Standard Practice for Performance Testing of Shipping Containers and Systems