GB 5817-1986
Replaced
GB/T 16292-2025
Pending
National standards
GB/T 16292-2025 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
GB/T 16292-2025 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
Basic Information
Standard Code:
GB/T 16292-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Workplace air
Publish Date:
2025-10-05
Implement Date:
2026-11-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
20 pages
Scope
本文件描述了医药工业洁净室(区)空气悬浮粒子浓度的测试方法。
本文件适用于医药工业洁净室(区)的空气悬浮粒子测试。
Development Information
Drafting Units:
中国食品药品检定研究院、山东省医疗器械和药品包装检验研究院、上海市食品药品包装材料测试所、北京市药品检验研究院、天津市药品检验研究院、河北省药品医疗器械检验研究院、联勤保障部队药品仪器监督检验总站、中国建筑科学研究院有限公司、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)
Drafting Persons:
赵霞、谢兰桂、张鹏、孙会敏、魏佳鸣、江志杰、黎阳、高燕霞、倪明、曹国庆、王霖、于晓慧
Replace the following standards
Referenced Standards
GB/T 29024.4-2017 Determination of particle size distribution—Single particle light interaction methods—Part 4:Light scattering airborne particle counter for clean spaces
GB/T 36066-2018 Cleanrooms and associated controlled environments—Analysis and application of test technology
GB/T 36066-2025 Cleanrooms and associated controlled environments—Technical requirements and application of testing
Related Standards
GB/T 5748-1985
Abolished
GB/T 5748-1985 Methods for airborne dust measurement in workplace
GB 8773-1988
Abolished
GB 8773-1988 Hygienic standard for methylacrylate in the air of workplace
GB 8774-1988
Abolished
GB 8774-1988 Hygienic standard for antimony and its compounds in the air of workplace
GB 8775-1988
Abolished
GB 8775-1988 Hygienic standard for allyl chloride in the air of workplace
GB 8776-1988
Abolished