Bacterial Endotoxin for Intrathoracic Medical Devices Requirement Revisited / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 96-98, 2022.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-928866
Responsible library:
WPRO
ABSTRACT
Bacterial endotoxin is considered as one of the critical risk factors in medical devices, especially implanted devices that directly or indirectly contact with blood circulating system. In that case, endotoxin limits for implanted medical devices is important in determine the safety of medical devices. According to GB/T 14233.2-2005, the requirements of endotoxin index for intrathoracic medical devices is 2.15 EU per device. However, the definition of "intrathoracic medical devices" is vague. Specifically, "for cardiovascular system application" instead of "intrathoracic application" is more reasonable. With the deeper understanding of the risk of endotoxin in medical devices and considering the internationally accepted standards, the limits of endotoxin in medical devices for cardiovascular system application is acceptable at 20 EU per device.
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Endotoxins
Type of study:
Risk factors
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2022
Document type:
Article