GB 18278-2000
Replaced
YY/T 0567.2-2021
Active
Industry standards-Medicine
YY/T 0567.2-2021 Aseptic processing of health care products—Part 2:Sterilizing filtration
YY/T 0567.2-2021 Aseptic processing of health care products—Part 2:Sterilizing filtration
Basic Information
Standard Code:
YY/T 0567.2-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2021-03-09
Implement Date:
2022-04-01
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:
30 pages
Scope
YY/T 0567的本部分规定了除菌过滤的术语和定义、质量体系要素、除菌过滤器特性确定、过程和设备特性确定、流体定义、过程定义、确认、常规监测和控制、除菌过滤产品放行和保持过程有效性。
本部分适用于医疗器械生产中除菌过滤过程的建立、确认和常规操作。
本部分不适用于病毒的去除。除菌过滤不适用于含有效成分粒子大于过滤孔径的流体（例如全细胞细菌疫苗)。
本部分不适用于高效空气过滤器（HEPA)。
本部分没有具体说明去除海绵状脑病，如羊痒病、牛海绵状脑病和克雅氏病等病原体的过程的开发、确认和常规控制的要求。
Development Information
Drafting Units:
广东省医疗器械质量监督检验所、浙江泰林生物技术股份有限公司、杭州德柯医疗科技有限公司、强生(苏州)医疗器材有限公司、苏州市倍咏医疗科技有限公司
Drafting Persons:
苗晓琳、王花、周志龙、刘雪美、徐星岗、赵振波、徐静、邵南、钟静
Replace the following standards
Referenced Standards
ISO 13408-1:2008
ISO 13408-1:2008/Amd.1:2013
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1
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 19971-2005 Sterilization of health care products—Vocabulary
GB/T 19971-2015 Sterilization of health care products—Vocabulary
YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0567.5-2011 Aseptic processing of health care products—Part 5:Sterilization in place
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 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards
Adopt standards
ISO 13408-2:2018
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