YY/T 0618-2017 Translated English of Chinese Standard (YY/T 0618-2017, YYT0618-2017): Test methods for bacterial endotoxins of medical devicesí¬Routine monitoring and alternatives to batch testing

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https://www.chinesestandard.net, Dec 6, 2022 - Medical - 53 pages
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.
 

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Contents

Foreword
3
Use of technique
20
Informative Outofspecification OOS and failure investigation guide
50

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