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Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
Standard in brief
Scope of Application：
1.1 本文件规定了医疗器械辐射灭菌过程的开发、确认和常规控制的要求。
本文件适用于使用以下辐射源的辐照装置:
a) 使用放射性核素钴-60或铯-137;
b) 电子加速器发出的电子束;
c) X射线发生器发出的X射线。
Basic information
Standard No：GB 18280.1-2025
Standard Name：医疗产品灭菌 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
English Name：Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
Standard Status：即将实施
Release Date：2015-12-31
Effective Date：2029-01-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.01
CCS Number：C47
Related Standards
Referenced Standards：GB/T 19973.1,GB/T 19973.2
Adopted Standards：ISO 11137-1:2025
Adopted Standard Name：《医疗产品灭菌 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》
Adoption Level：MOD
Publication Information
Number of pages：40
Number of words：63 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2025-12-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家市场监督管理总局、国家标准化管理委员会
Standard Type：CN
Standard Attribute：GB
Other Standard Number：18280.1
Management Organization：国家药品监督管理局
Proposing Department：国家药品监督管理局
