止血夹注册检测

项目说明

标准编号

标准名称

生物学评价

ISO 10993-1:2025

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 10993-11:2017

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

灭菌过程管理

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 — Amendment 1

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

灭菌效果检测（生产过程）

ISO 11731-1:2018

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

ISO 11737-2:2019

Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 10993-7:2008

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

包装运输

ASTM D 4169

Standard Practice for Performance Testing of Shipping Containers and Systems