T/CIQA 17-2021 Mobile nucleic acid testing laboratory general technical specification
T/CIQA 17-2021 Mobile nucleic acid testing laboratory general technical specification
Basic Information
Scope
This document specifies the basic requirements for the design, structure, and performance of mobile nucleic acid testing laboratories, as well as testing methods, inspection rules, and product marking, packaging, and transportation. This document includes basic requirements for mobile nucleic acid testing laboratories, including protection for personnel, samples, and the environment, biosafety, durability, and pressure gradient, structural stability, cleanliness, environmental disinfection capability, noise level restrictions, lighting, vibration, and ventilation equipment.
This document applies to mobile nucleic acid testing laboratories used in clinical gene amplification nucleic acid testing, and stipulates that laboratories that comply with this document can pass the test.