Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
15,146
Date of Issue
2018-09-28
Date of Implementation
2020-04-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the terms and definitions, requirements, test methods, labels, packaging marks and instructions for use, packaging, transportation and storage of medical carbon dioxide incubators. This standard applies to medical carbon dioxide incubators for culturing human-derived samples such as biological cells, tissues and bacteria in clinical tests. The upper limit of the cultivation temperature of the incubator applicable to this standard is 55��C, the lower limit of the temperature is 3��C to 5��C higher than the ambient temperature, the control range of carbon dioxide concentration is 0% to 20%, and the internal volume is 100L to 300L.
