YY/T 0618-2007 Bacterial endotoxins—Test methodologies,routine monitoring,and alternatives to batch testing

Scope

This standard specifies the basic guidelines for the bacterial endotoxin testing methods used to determine the bacterial endotoxin content of medical devices, components, or raw materials. Note: Although the scope of this standard is limited to medical devices, the requirements and guidelines provided in this standard may also be applicable to other medical products. The bacterial endotoxin testing methods specified in this standard include both qualitative and quantitative methods. This standard does not apply to the determination of pyrogens other than bacterial endotoxins. This standard does not specify acceptable levels of bacterial endotoxins. Note: The acceptable levels of bacterial endotoxins should be referred to the applicable standards.

Development Information

Superseded by the following standards

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