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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 14-360
Standard
ANSI AAMI ST72:2011/(R)2016
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
Scope/Abstract
This recommended practice specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on sterilized or sterilizable healthcare products, components or raw materials. Endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods. The recommended practice excludes determination 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
USP 39-NF34:2016 <85> Bacterial Endotoxins Test.

USP 39-NF34:2016 <161> Transfusion and Infusion Assemblies and Similar Medical Devices.

Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, June 2012.
FDA Technical Contact
 Elizabeth Gonzalez
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6826
  Elizabeth.Gonzalez@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Sterility
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