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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 063 Date of Entry 09/09/2024 
FR Recognition Number 14-604
Standard
ISO  11737-3 First Edition 2023-06
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
Scope/Abstract
1.1 Inclusions
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents.

1.2 Exclusions

1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included.

1.2.2 This document does not address setting specific endotoxin limit specifications
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.
Relevant FDA Guidance and/or Supportive Publications*
ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

USP 42-NF37:2019 <85> Bacterial Endotoxins Test.

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff, issued January 2024.

FDA Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, issued 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 Contacts
 Angel Soler-Garcia
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6535
  Angel.Soler-Garcia@fda.hhs.gov
 Poulomi Nandy
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-7048
  Poulomi.Nandy@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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