GB 18278-2000
Replaced
YY/T 1268-2023
Active
Industry standards-Medicine
YY/T 1268-2023 Product adoption and process equivalence for ethylene oxide sterilization
YY/T 1268-2023 Product adoption and process equivalence for ethylene oxide sterilization
Basic Information
Standard Code:
YY/T 1268-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2023-03-14
Implement Date:
2024-05-01
Publisher:
国家药品监督管理局
Technical Committee:
全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Pages:
14 pages
Scope
本文件规定了医疗器械环氧乙烷灭菌过程中新产品或变更的产品追加到已经确认的灭菌过程的要求，并为使用不同灭菌设备时评估灭菌过程等效性提供方法。
本文件适用于经环氧乙烷灭菌处理、采用传统放行或参数放行的医疗器械。
本文件适用的医疗器械环氧乙烷灭菌情况包括：
a) 在已经确认的环氧乙烷灭菌过程中增加新产品；
b) 评估已确认产品的变更；
c) 已确认的过程转移到不同的场地或设备；
d) 评估灭菌过程的等效性。
Development Information
Drafting Units:
苏州诺洁医疗技术有限公司、杭州唯强医疗科技有限公司、广东省医疗器械质量监督检验所、新乡市华西卫材有限公司、泰尔茂医疗产品(杭州)有限公司
Drafting Persons:
徐海英、周志龙、洪梓祥、徐占利、崔文波、翁辉、刘雪美、周光宇、林曼婷
Replace the following standards
Referenced Standards
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