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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 041 Date of Entry 04/04/2016 
FR Recognition Number 14-333
Standard
ISO  17665-1 First edition 2006-08-15
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Identical Adoption
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
Scope/Abstract
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
-saturated steam venting systems;
-saturated steam active air removal systems;
-air steam mixtures;
-water spray;
-water immersion.
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*
Parenteral Drug Association Technical Report No. 1 (Revised 2007), Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.

ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.

AAMI TIR 17:2008 Compatibility of materials subject to sterilization.

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
 Clarence Murray
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-0270
  Clarence.Murray@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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