喉镜用窥视片注册检测

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

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

性能指标

ISO 7376:2020

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation

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