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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 14-277
Standard
ISO  TS 17665-2 First edition 2009-01-15
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
Identical Adoption
ANSI AAMI ISO TIR 17665-2:2009
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
Scope/Abstract
ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.
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.
Transition Period
FDA recognition of ISO TS 17665-2 First edition 2009-01-15 [Rec# 14-277], and ISO 17665-1 First edition 2006-08-15 [Rec# 14-333] will be superseded by recognition of ISO 17665 First edition 2024-03 [Rec# 14-601]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-277] and [Rec# 14-333] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 14-277] and [Rec# 14-333] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where moist heat sterilization is a component of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
1. ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

2. AAMI TIR17:2017 Compatibility of materials subjected to sterilization.

3. Parenteral Drug Association Technical Report No. 1 (Revised 2007), Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.

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
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@fda.hhs.gov
 Diane Smith
  CDRH/OPEQ/OHTIV/
  --
  Diane.Smith@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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