GB/T 17857-1999
Active
DB32/T 4271-2022
Active
Jiangsu ProvinceLocal standards
DB32/T 4271-2022 The inspection specifications for clean rooms (areas) in medical devices
DB32/T 4271-2022 The inspection specifications for clean rooms (areas) in medical devices
Basic Information
Standard Code:
DB32/T 4271-2022
Standard Type:
Local standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Medical and Health Technology (Vocabulary)
Publish Date:
2022-05-20
Implement Date:
2022-06-20
Pages:
16 pages
Scope
This document specifies the requirements for inspectors of medical device cleanrooms (areas), as well as inspection preparation, technical requirements, and inspection methods. This document is applicable to the inspection of air cleanliness in medical device cleanrooms (areas).
Development Information
Referenced Standards
GB/T 16292-2010 Test method for airborne particles in clean room (zone) of the pharmaceutical industry
GB/T 16293-2010 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
GB/T 16294-2010 Test method for settling microbe in clean room(zone) of the pharmaceutical industry
GB 50073-2013 Code for design of clean room
Related Standards
GB 18466-2001
Replaced
GB 18466-2001 Requirements for medical organization sewage discharge
GB 18467-2001
Replaced
GB 18467-2001 Health examination criteria of blood donors
GB 18469-2001
Replaced
GB 18469-2001 Standards for whole blood and blood components quality
WS 233-2002
Abolished
WS 233-2002 General biosafety standard for microbiological and biomedical laboratories
YY/T 0468-2003
Replaced