AAMI TIR17-2017 PDF

Full title and description

ANSI/AAMI TIR17:2017 — Compatibility of materials subject to sterilization. A technical information report that provides guidance to medical device and health care product manufacturers on selecting and qualifying polymeric materials, ceramics, and metals that will be exposed to terminal sterilization or sterilant processes. The report addresses multiple sterilization modalities and includes modality-specific annexes with compatibility information and recommended test approaches.

Abstract

AAMI TIR17:2017 offers practical guidance for evaluating how common device materials respond to a range of sterilization methods (radiation, ethylene oxide, moist heat, dry heat, hydrogen peroxide–based systems, nitrogen dioxide, peracetic acid, and related modalities). It describes general test strategies, accelerated and real‑time aging considerations, and provides supporting annex material that summarizes modality‑specific compatibility concerns and example test methods to help reduce unnecessary testing while assuring device performance after sterilization.

General information

• Status: Published — original publication 11 June 2017; reaffirmed 23 December 2020. Note: a later edition (AAMI TIR17:2024) was published by AAMI on 15 October 2024; users should confirm the edition required for regulatory or contract purposes.
• Publication date: 11 June 2017 (reaffirmed 23 December 2020).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI), Arlington, Virginia, USA.
• ICS / categories: 11.080 (Sterilization and disinfection); related to 11.040 (Medical equipment).
• Edition / version: TIR (Technical Information Report) — AAMI TIR17:2017 (2017 edition; reaffirmed 2020).
• Number of pages: 123 pages.

Scope

This TIR gives manufacturers and sterilization specialists guidance on selecting, testing, and qualifying materials intended for use in products that will undergo terminal sterilization. It covers a broad set of sterilization modalities (radiation, ethylene oxide, moist and dry heat, various hydrogen peroxide-based systems, nitrogen dioxide, peracetic acid in vapor and liquid forms, and related combinations) and discusses modality‑specific risks to polymers, ceramics, and metals. The report addresses test selection (mechanical, chemical, surface, and functional testing), accelerated aging strategies, modality switching considerations, and documentation approaches to support design validation and regulatory submissions.

Key topics and requirements

• Overview of sterilization modalities and fundamental mechanisms by which each modality can affect materials (oxidation, hydrolysis, chain scission, crosslinking, plasticizer loss, discoloration, etc.).
• Material classes addressed: common medical polymers, elastomers, engineering plastics, ceramics, and metals.
• Guidance on selection of compatibility test methods (mechanical testing, tensile/elongation, hardness, surface analysis, spectroscopy, thermal analysis, extractables/leachables where appropriate).
• Recommendations for accelerated and real‑time aging programs to assess long‑term effects post‑sterilization, including test matrix design and acceptance criteria considerations.
• Annexes with modality‑specific notes and compatibility tables intended to aid initial material selection and prioritize testing effort.
• Discussion of modality switching (changing from one sterilization method to another) and how to evaluate impact on product performance and regulatory strategy.
• Practical advice for documenting qualification evidence for design history files and regulatory submissions.

Typical use and users

AAMI TIR17:2017 is used by medical device designers, materials engineers, sterility assurance and validation teams, regulatory affairs professionals, contract sterilization providers, quality engineers, and suppliers of device components. Typical uses include early material selection, planning qualification test programs, documenting sterilization compatibility in design validation, and informing risk assessments when considering changes to sterilization modality or supplier materials.

Related standards

Documents commonly used alongside AAMI TIR17 include: ANSI/AAMI ST58 (chemical sterilization and high‑level disinfection), ANSI/AAMI ST24 (ethylene oxide sterilizers), AAMI TIR16 (EO process microbiology guidance), ISO 11135 (ethylene oxide sterilization validation), ISO 22441 / ISO 22441:2022 (low‑temperature vaporized hydrogen peroxide requirements), ISO 11607 (packaging for terminally sterilized medical devices), ISO 14937 (general sterilization validation), and ISO 10993‑1 (biocompatibility evaluation). Users should refer to the current editions of those documents for normative requirements.

Keywords

sterilization, material compatibility, polymers, elastomers, ceramics, metals, ethylene oxide, radiation, moist heat, dry heat, vaporized hydrogen peroxide, peracetic acid, nitrogen dioxide, accelerated aging, sterilization validation, modality switching, sterility assurance

FAQ

Q: What is this standard?

A: AAMI TIR17:2017 is a technical information report that provides guidance on the compatibility of medical‑device materials with various sterilization processes. It is a guidance document (TIR) rather than a prescriptive test standard.

Q: What does it cover?

A: The report covers mechanisms of material change from sterilization, recommended test approaches (mechanical, chemical, surface, accelerated aging), modality‑specific considerations (annexes), and practical guidance for material selection, qualification testing, and documentation to support device validation and regulatory filings.

Q: Who typically uses it?

A: Medical device manufacturers (R&D, materials science, validation, quality, and regulatory teams), contract sterilizers, material suppliers, and sterility assurance professionals use this TIR to plan and justify material compatibility and sterilization qualification efforts.

Q: Is it current or superseded?

A: The 2017 edition was published 11 June 2017 and reaffirmed 23 December 2020. A later edition, AAMI TIR17:2024, was published on 15 October 2024 and contains updated compatibility tables and expanded modality coverage; users should check AAMI for the edition required for their work and for the most current guidance.

Q: Is it part of a series?

A: Yes — TIR17 is part of AAMI’s series of Technical Information Reports and guidance documents addressing sterilization, sterility assurance, and related topics. It is intended to complement AAMI ST and ISO standards on sterilization processes and validation.

Q: What are the key keywords?

A: sterilization, material compatibility, polymers, ethylene oxide (EO), radiation, vaporized hydrogen peroxide (VH2O2), peracetic acid, nitrogen dioxide, accelerated aging, sterilization validation.