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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 14-541
Standard
ANSI AAMI  ST72:2019
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
Scope/Abstract
1.1 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.
NOTE Although the scope of this standard is limited to medical devices, it also includes requirements and provides testing guidance that might be applicable to other health care products, such as, biologics, tissue-based products and combination products.
1.2 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where endotoxin testing is a component of the development, manufacture, and/or release of the product.
Relevant FDA Guidance and/or Supportive Publications*
1. USP 42-NF37:2019 <85> Bacterial Endotoxins Test.

2. USP 42-NF37:2019 <161> Transfusion and Infusion Assemblies and Similar Medical Devices.

3. Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, June 2012.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Christopher Dugard
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-6031
  christopher.dugard@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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