ANSI/AAMI ST72:2019
Current
Current
The latest, up-to-date edition.
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
19-11-2019
€224.46
Excluding VAT
This document 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.
| DocumentType |
Test Method
|
| ISBN |
978-1-57020-731-0
|
| Pages |
65
|
| ProductNote |
THIS STANDARD ALSO REFERS:ISO 11138,ISO 17025,PDA TR 67
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI ST108:2023 | Water for the processing of medical devices |
| NS-EN ISO 13408-1:2024 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) |
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