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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 058 Date of Entry 05/30/2022 
FR Recognition Number 14-577
Standard
ISO  11737-1 Third edition 2018-01 [Including AMD1:2021]
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
Scope/Abstract
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.

NOTE 2 See Annex A for guidance on Clauses 1 to 9.

ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022.

ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
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*
ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

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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