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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 12/23/2024 
FR Recognition Number 14-608
Standard
AAMI  TIR106:2024
Microbiological methods - Understanding and use of product bioburden data
Scope/Abstract
This document provides guidance regarding the understanding and use of product bioburden data including: what bioburden data represent; how to use bioburden data to support a sterilization process; the analysis and characterization of bioburden; establishment and the use of alert and action levels; how to investigate bioburden excursions; trending and maintaining an effective bioburden monitoring program; counting plates and recording results.
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/ISO 11737-1:2018 Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms.

ANSI/AAMI/ISO 11137-2: 2013/(R2019) Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

ISO 13004 First edition 2022-10 Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD.

ISO 11737-2 Third edition 2019-12 Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process.

ANSI/AAMI/ ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices.

ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

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

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
 Angel Soler-Garcia
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6535
  Angel.Soler-Garcia@fda.hhs.gov
Standards Development Organization
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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