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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 062 Date of Entry 05/29/2024 
FR Recognition Number 14-601
Standard
ISO  17665 First edition 2024-03
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Scope/Abstract
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

1.1 Inclusions

Moist heat sterilization processes covered by this document include, but are not limited to:
a) saturated steam sterilization in which air is removed by passive purging (gravity displacement principle);
b) saturated steam sterilization in which air is removed by active air removal (dynamic air removal, pre-vacuum/fractionated vacuum principle);
c) contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;
d) contained product sterilization in which heat transfer is achieved by water sprays;
e) contained product sterilization in which heat transfer is achieved by water immersion.

NOTE 1 See Annex D where the processes are explained further.

NOTE 2 Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products and industrial applications.

1.2 Exclusions

1.2.1 This document does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE 1 See ISO 22442-1, ISO 22442-2 and ISO 22442-3.

NOTE 2 Specific regulations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

1.2.2 This document does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.

1.2.3 This document does not detail a specified requirement for designating a medical device as "sterile."

NOTE National or regional requirements can designate medical devices as "sterile." See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.

NOTE There can be applicable national or regional regulations for operational safety.

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)*
Regulation Number Device Name Device Class Product Code
§880.2800 Indicator, Biological Sterilization Process Class 2 FRC
§880.2800 Indicator, Physical/Chemical Sterilization Process Class 2 JOJ
§880.2800 A Chemical Vapor Sterilization Multivariable Chemical Indicator Class 2 QKM
§880.6850 Wrap, Sterilization Class 2 FRG
§880.6850 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class 2 KCT
§880.6880 Sterilizer, Steam Class 2 FLE
21 CFR 820.3 Definitions
21 CFR 801 Labeling
21 CFR 820.3 Definitions
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities, issued March 1993.

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, issued November 1994.

Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions - Guidance for Industry and Food and Drug Administration Staff, issued October 2007.

Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and Food and Drug Administration Staff, issued December 2003.

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
 Paulo R. Laranjeira
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9024
  Paulo.Laranjeira@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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