一次性阴道扩张器注册检测

项目说明

标准编号

标准名称

性能测试

YY 0336-2020

一次性使用无菌阴道扩张器

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 系列

包装 运输包装件基本试验

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

GB/T 19633.2-2024

最终灭菌医疗器械包装 第2部分：成型、密封和装配过程的确认的要求

YY/T 0681系列

无菌医疗器械包装试验方法

灭菌工艺

GB 18279.1-2015

医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求

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

GB 18280.1-2015

医疗保健产品灭菌 辐射 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 0615.1-2007

标示“无菌”医疗器械的要求 第1部分：最终灭菌医疗器械的要求

项目说明

标准编号

标准名称

生物学评价

ISO 10993-1:2018

Biological evaluation of medical devices Part 1:Evaluation and testing within a risk management process

ISO 10993-5:2009

Biological evaluation of medical devices Part 15: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

Performance Testing of Shipping Containers and Systems

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 F系列

ASTM F1980-21: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

灭菌工艺

ISO 11135:2014

Sterilization of health-care products — Ethylene oxide — 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 07:Ethylene oxide sterilization residuals

ISO 11137-1:2006

Sterilization of health care products - Radiation - Part 1Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices