This standard specifies basic guidelines for test methods for bacterial endotoxins, which are applicable to the determination of medical devices, components or raw materials. Note. Although the scope of this standard is limited to medical devices, the requirements specified in this standard and the guidelines given may also apply to other medical products. This standard does not apply to the evaluation of pyrogens, other than bacterial endotoxin.
Basic Data
Standard ID
YY/T 0618-2017 (YY/T0618-2017)
Description (Translated English)
Test methods for bacterial endotoxins of medical devices - Routine monitoring and alternatives to batch testing
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
