血管吻合轮注册检测

性能要求

YY/T 0245-2008

吻（缝）合器通用技术条件

YY/T 0149-2006

不锈钢医用器械 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 16886.4-2022

医疗器械生物学评价 第4部分：与血液相互作用试验选择

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 16886.12-2023

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

热原试验

中国药典2025年版 1142

热原检查法

GB/T 14233.2-2005

医用输液、输血、注射器具检验方法 第2 部分：生物学试验方法

清洗消毒灭菌验证

WS 310-2016系列

医院消毒供应中心 系列

WS/T 367-2012

医疗机构消毒技术规范

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

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

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 27955-2020

过氧化氢气体等离子体低温灭菌器卫生要求

医疗器械包装运输验证

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

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

YY/T 0681.16-2019

无菌医疗器械包装试验方法 第16 部分:包装系统气候应变能力试验

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

性能要求

ISO 13402:2025

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 10993-4:2017

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

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 10993-12:2021

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

ASTM F3208-20

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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

AAMI TIR 12-2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

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 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

医疗器械包装运输验证

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

ASTM D4169-23el

Standard Practice for Performance Testing of Shipping Containers and Systems