Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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14-609
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Standard | |
AAMI TIR17:2024 Compatibility of materials subjected to sterilization |
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Scope/AbstractThis technical information report provides guidance for health care product manufacturers in the qualification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or X-ray), b) ethylene oxide, c) moist heat (steam), d) dry heat, e) vaporized hydrogen peroxide, f) nitrogen dioxide, g) peracetic acid, h) liquid peracetic acid, i) hydrogen peroxide-ozone, and j) chlorine dioxide. Annexes address the specific sterilization modalities concerns. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of AAMI TIR17:2017/(R)2020 [Rec# 14-588] will be superseded by recognition of AAMI TIR17:2024 [Rec# 14-609]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-588] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 14-588] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.6100 |
Cabinet, Ethylene-Oxide Gas Aerator
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Class 2
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FLI
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§880.6860 |
Sterilizer, Ethylene-Oxide Gas
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Class 2
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FLF
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§880.6860 |
Sterilizer, Chemical
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Class 2
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MLR
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§880.6870 |
Sterilizer, Dry Heat
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Class 2
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KMH
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§880.6880 |
Sterilizer, Steam
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Class 2
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FLE
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§880.6880 |
Sterilizer Automated Loading System
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Class 2
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PEC
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New Technology Sterilizer (ie H2O2) |
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Relevant FDA Guidance and/or Supportive Publications*
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices.
AAMI TIR12 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers.
AAMI TIR100 End-to-End Microbiological Quality and Sterility Assurance.
AAMI TIR104 Guidance on transferring health care products between radiation sterilization sources.
AAMI ST79 Comprehensive Guide to Steam 2023 Sterilization and Sterility Assurance in Healthcare Facilities.
AAMI ST58 Chemical Sterilization and High Level Disinfection in Healthcare Facilities.
ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.
ANSI/AAMI ST67 Sterilization of health care products -- Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile."
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
ISO 11135 Second edition 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)].
ISO 11137-1 First edition 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)].
ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)].
ISO 11137-3 Second edition 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
ISO/TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control.
ISO 14160 Third Edition 2020-09 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices.
ISO 14937 Second edition 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
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.
ISO 20857 First edition 2010-01 Sterilization of Healthcare Products - Dry Heat - Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
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.
Submission and Review of Sterility Information in Pre-Market Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff, issued January 2024.
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities, issued March 1993.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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