YY/T 0618-2007
Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing (English Version)
- Standard No.
- YY/T 0618-2007
- Language
- Chinese, Available in English version
- Release Date
- 2007
- Published By
- Professional Standard - Medicine
- Status
- 2018-01
- Replace By
- YY/T 0618-2017
- Latest
- YY/T 0618-2017
- Scope
- This standard specifies basic guidelines for test methods for the determination of bacterial endotoxins in medical devices, components or raw materials. Note: Although the scope of this standard is limited to medical devices, the requirements specified and the guidance given in this standard may also apply to other medical products. The bacterial endotoxin test methods given in this standard include 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: Acceptable levels of bacterial endotoxins should be referred to applicable standards.
YY/T 0618-2007 history
- 2018 YY/T 0618-2017 Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing
- 2007 YY/T 0618-2007 Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing
