[Bacterial Endotoxin for Intrathoracic Medical Devices Requirement Revisited].
Zhongguo Yi Liao Qi Xie Za Zhi
; 46(1): 96-98, 2022 Jan 30.
Article
en Zh
| MEDLINE
| ID: mdl-35150117
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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Endotoxinas
Idioma:
Zh
Revista:
Zhongguo Yi Liao Qi Xie Za Zhi
Año:
2022
Tipo del documento:
Article
Pais de publicación:
China