AAMI TIR17-2024 PDF

Full title and description

AAMI TIR17:2024 — Compatibility of materials subject to sterilization. This Technical Information Report (TIR) provides guidance to manufacturers, designers, sterilization specialists, and sterile processing professionals on selecting, qualifying, testing, and documenting the compatibility of polymeric materials, metals, ceramics and assemblies with commonly used sterilization and high‑level decontamination modalities.

Abstract

AAMI TIR17:2024 summarizes material performance considerations, test approaches, and compatibility ratings for materials and components exposed to sterilization processes. The document covers radiation (gamma, electron beam, X‑ray), ethylene oxide (EO), moist heat (steam), dry heat, vaporized hydrogen peroxide (VH2O2) and VH2O2–ozone, nitrogen dioxide, peracetic acid (vapor and liquid), and chlorine dioxide. It provides guidance on designing material qualification programs, accelerated/exposure testing, acceptance criteria, and considerations for packaging, labeling and device function after processing.

General information

• Status: Published — current (2024 edition; supersedes the 2017 edition).
• Publication date: December 13, 2024 (2024 edition).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: 11.080 (Sterilization and disinfection); 11.040 (Medical equipment).
• Edition / version: 2024 edition (AAMI TIR17:2024).
• Number of pages: 112 pages.

Scope

TIR17:2024 provides non‑mandatory, technical guidance on assessing and documenting how materials and finished medical products respond to sterilization and high‑level decontamination processes. The report focuses on practical test methods, exposure conditions, property endpoints, and interpretation of results to support material selection, design verification, supplier control and regulatory submissions. It does not replace modality‑specific validation standards but is intended to complement them by addressing material compatibility and expected property changes after processing.

Key topics and requirements

• Overview of sterilization and high‑level decontamination modalities relevant to material compatibility (radiation, EO, steam, dry heat, VH2O2, nitrogen dioxide, peracetic acid, chlorine dioxide, etc.).
• Material classes covered: common polymers, elastomers, adhesives, metals, coatings, ceramics and multi‑layer assemblies.
• Recommended test endpoints: mechanical (tensile, elongation, hardness), dimensional stability, chemical degradation, discoloration, optical clarity, leachables/extractables, surface properties and functional performance.
• Suggested exposure protocols and accelerated aging approaches to simulate repeated or long‑term sterilization exposures.
• Compatibility rating system and guidance for interpreting acceptability for intended use and risk management.
• Guidance on establishing supplier information packages, certificates of compatibility, and documentation to support regulatory submissions.
• Considerations for packaging materials and interactions between packaging and device materials during sterilization.
• Annexes or modality‑specific notes outlining known material sensitivities and common failure modes for each sterilization method.

Typical use and users

AAMI TIR17:2024 is used by medical device manufacturers (R&D, materials engineering, and regulatory affairs), contract sterilization providers, sterile processing departments (hospital central sterile/sterile processing), quality engineers, test laboratories, and standards developers. It is particularly valuable when selecting materials for new devices, qualifying suppliers, investigating material failures after sterilization, or preparing sterilization/compatibility sections of regulatory filings.

Related standards

Commonly used companion and referenced documents include AAMI/ANSI sterilization standards and technical reports (for example ST24 and ST58), modality‑specific ISO standards such as ISO 11135 (ethylene oxide), ISO 11137 (radiation sterilization), ISO 17665 (moist heat sterilization), ISO 14971 (risk management for medical devices), and other AAMI TIRs addressing sterility assurance, bioburden, and microbiological methods.

Keywords

materials compatibility, sterilization, ethylene oxide, gamma irradiation, electron beam, e‑beam, steam sterilization, moist heat, dry heat, vaporized hydrogen peroxide, peracetic acid, chlorine dioxide, nitrogen dioxide, medical devices, polymer qualification, accelerated aging, packaging compatibility, sterilization validation support.

FAQ

Q: What is this standard?

A: AAMI TIR17:2024 is a Technical Information Report offering practical guidance on how different sterilization and high‑level decontamination methods affect materials used in health care products and how to qualify and document material compatibility.

Q: What does it cover?

A: It covers material classes (polymers, elastomers, metals, ceramics, adhesives), the effects of multiple sterilization modalities (radiation, EO, steam, dry heat, VH2O2, peracetic acid, chlorine dioxide, nitrogen dioxide, etc.), recommended test endpoints, exposure protocols, interpretation of results, and documentation best practices to support device performance and regulatory needs.

Q: Who typically uses it?

A: Device designers, materials engineers, quality and regulatory personnel at medical device manufacturers, contract sterilizers, testing laboratories, and sterile processing professionals use TIR17 when selecting materials, designing qualification test plans, or investigating sterilization‑related material issues.

Q: Is it current or superseded?

A: The 2024 edition is the current edition and supersedes the previous (2017) edition.

Q: Is it part of a series?

A: Yes. TIR17 is one of several AAMI Technical Information Reports and standards addressing sterilization, sterility assurance and device‑related topics; it is intended to complement modality‑specific standards and other AAMI guidance documents.

Q: What are the key keywords?

A: Key keywords include materials compatibility, sterilization, ethylene oxide, gamma, e‑beam, steam, hydrogen peroxide, peracetic acid, chlorine dioxide, polymers, metals, ceramics, packaging compatibility, and material qualification.