AAMI ST72

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Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)

Published by Publication Date Number of Pages
AAMI 11/01/2019 65
Category:

Description

AAMI ST72 – Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing, Includes Erratum (2020)

Specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.

The purpose of this document is to consolidate the requirements and guidance for testing for bacterial endotoxins. This includes product required to be non-pyrogenic due to intended use and non-pyrogenic labelling. Details are also provided on selection of product units, method suitability, use of techniques for routine testing, interpretation of test results, and alternatives to batch testing and risk assessment.

Product Details

Published:
11/01/2019
ISBN(s):
9781570207310
ANSI:
ANSI Approved
Number of Pages:
65
File Size:
1 file , 1.6 MB
Note:
This product is unavailable in Russia, Ukraine, Belarus

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