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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 060 Date of Entry 05/29/2023 
FR Recognition Number 14-586
Standard
ISO  22441 First edition 2022-08
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Scope/Abstract
1.1 Inclusions
1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.
NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.

1.2 Exclusions
1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document.
NOTE See ISO 14937 for guidance on validation of such processes.
1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information).
1.2.3 This document does not specify requirements for designating a medical device as sterile.
...
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.

NOTE: Defined critical parameters can vary depending on the technology and cycle design of various VH2O2 sterilizers. If you are considering releasing product loads using parametric release, please pay attention to process variables [see definition 3.32 and 3.33] to monitor when releasing product loads using parametric release [see definition 3.28]. We encourage you to contact the review division for your device regarding the appropriate parameters to monitor for parametric release of product loads sterilized with VH2O2.

Please consider published literatures #1 through #4 listed below.
Relevant FDA Guidance and/or Supportive Publications*
1. USP-NF M7420_01_01 <1229.11> Vapor Phase Sterilization.

2. Dufresne S and Richards T. The first dual-sterilant low-temperature sterilization system. Canadian Journal of Infection Control 2016; 31(3): 169-174.

3. Hultman C, Hill A, McDonnel G. The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide. Pharmaceutical Engineering 2007; 27(1): 22-32.

4. Unger-Bimczok B, Kottke V, Hertel C, Rauschnabel J. The Influence of Humidity, Hydrogen Peroxide Concentration, and Condensation on the Inactivation of Geobacillus stearothermophilus Spores with Hydrogen Peroxide Vapor. Journal of Pharmaceutical Innovation 2008; 3: 123-133.

5. AAMI/TIR17:2017/(R)2020 Compatibility of materials subject to sterilization.

6. Guidance for Industry and Food and Drug Administration Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016.

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
 Clarence Murray
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-0270
  Clarence.Murray@fda.hhs.gov
 Ryan Ortega
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-2303
  Ryan.Ortega@fda.hhs.gov
 Christopher Dugard
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  240-402-6031
  christopher.dugard@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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