GB 18278-2000
Replaced
GB/T 18280.2-2025
Pending
National standards
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
Basic Information
Standard Code:
GB/T 18280.2-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2025-12-02
Implement Date:
2027-07-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Pages:
68 pages
Scope
本文件规定了用于满足特定无菌要求所需的最小剂量的设定方法和证实15 kGy、17.5 kGy、20 kGy、22.5 kGy、25 kGy、27.5 kGy、30 kGy、32.5 kGy或者35 kGy作为能达到10-6无菌保证水平(SAL)的灭菌剂量的方法，以及用于证明灭菌剂量持续有效性的灭菌剂量审核方法。
本文件定义了用于灭菌剂量建立和灭菌剂量审核的产品族。
本文件适用于医疗器械辐射灭菌剂量的建立和保持。
注： 本文件适用于医疗器械，但辐射灭菌剂量的建立和保持能用于其他的产品。
Development Information
Drafting Units:
北京市射线应用研究中心有限公司、中金辐照股份有限公司、广东省医疗器械质量监督检验所、深圳市金鹏源辐照技术有限公司、上海辐新辐照技术有限公司、北京鸿仪四方辐射技术股份有限公司、同威信达技术(江苏)股份有限公司、山东蓝孚高能物理技术股份有限公司、惠州华阳医疗器械有限公司、山东安得医疗用品股份有限公司、常熟荣瑞灭菌技术有限公司
Drafting Persons:
张悦、陈强、宁锐剑、李梦媛、孔林、张经恒、李伟明、郝松松、刘燕琴、姜昊、张扬、史通、朱仪兵
Same series standard
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control
Replace the following standards
Referenced Standards
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products
GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.2-2005 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the validation of a sterilization process
GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process
GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2:Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13004
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
Adopt standards
ISO 11137-2:2013
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced