AAMI TIR28-2016 (2024) PDF

Full title and description

AAMI TIR28:2016/(R)2024 — Product adoption and process equivalence for ethylene oxide sterilization. This Technical Information Report provides guidance for adding new or modified medical devices into an existing validated ethylene oxide (EO) sterilization process and for determining when a sterilization process performed with different equipment can be considered equivalent. It is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

Abstract

This TIR offers practical recommendations and evaluation criteria to manufacturers, contract sterilizers, and quality/regulatory professionals for assessing product adoption into EO product families or EO processing categories and for demonstrating process equivalence across equipment or locations. Topics include considerations for parametric release, validation extension, equivalence testing, and documentation to support regulatory submissions.

General information

• Status: Current (reaffirmed edition).
• Publication date: March 26, 2024 (reaffirmation of the 2016 TIR).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: Sterilization of health care products; medical device sterility assurance; sterilization process validation.
• Edition / version: AAMI TIR28:2016/(R)2024 (2016 TIR, R2024 reaffirmation).
• Number of pages: 22 pages.

(Publication date, reaffirmation status, publisher, edition and page count referenced from AAMI product information and document history.)

Scope

The report addresses medical devices processed by ethylene oxide sterilization, including guidance on how to evaluate new or modified products for inclusion in an existing validated EO product family or processing category, and criteria for determining equivalence between EO processes run on different sterilizers or at different sites. It covers both conventional and parametric product release approaches and provides an annex with an evaluation guide for product adoption.

Key topics and requirements

• Principles and objectives for product adoption into an existing EO validated process.
• Criteria and methodologies for demonstrating process equivalence between different EO sterilization equipment or sites.
• Guidance on parametric product release and when parametric release can be applied.
• Validation extension, challenge testing, and acceptance criteria for adopted products.
• Risk assessment, documentation, and recordkeeping necessary to support adoption and equivalence decisions.
• Annex A: a practical evaluation guide for product adoption into an EO product family or processing category.

These topics are guidance-oriented (TIR) and provide recommended practices rather than prescriptive requirements.

Typical use and users

Primary users are medical device manufacturers, contract sterilization service providers, validation engineers, regulatory and quality assurance professionals, and testing laboratories. The TIR is used when a manufacturer introduces a new or modified product and needs to determine whether it can be processed using an already validated EO cycle, or when a sterilizer needs to justify equivalence of a process performed on different equipment or at a different location. It is also used to support regulatory submissions and declarations of conformity where applicable.

Related standards

Mainly intended to augment the ANSI/AAMI/ISO 11135 series (Sterilization of health care products — Ethylene oxide), providing additional guidance on adoption and equivalence. It is often considered alongside other AAMI TIRs and AAMI/ISO documents addressing sterilization validation, sterility assurance, and labeling. The TIR has also been included in FDA recognized-consensus listings related to EO sterilization guidance.

Keywords

ethylene oxide, EO sterilization, product adoption, process equivalence, parametric release, validation extension, sterilization validation, medical devices, AAMI TIR28.

FAQ

Q: What is this standard?

A: AAMI TIR28 is a Technical Information Report titled "Product adoption and process equivalence for ethylene oxide sterilization." It provides guidance (not mandatory requirements) to help evaluate whether new or modified products can be processed within an existing validated EO sterilization process and how to demonstrate equivalence of processes across equipment or sites.

Q: What does it cover?

A: It covers product-adoption criteria, equivalence assessment methods, considerations for parametric release, validation-extension approaches, challenge testing, documentation and risk assessment, and includes an annex with a practical evaluation guide.

Q: Who typically uses it?

A: Medical device manufacturers, contract sterilizers, validation engineers, QA/RA professionals, and laboratories use the TIR when introducing new or modified products to EO processing or when justifying process equivalence across different sterilization equipment or sites.

Q: Is it current or superseded?

A: The underlying document is AAMI TIR28:2016 and it was reaffirmed with an R2024 edition; the TIR is current as of the 2024 reaffirmation. Users should confirm the latest status before relying on it for regulatory submissions.

Q: Is it part of a series?

A: Yes — it is a Technical Information Report from AAMI intended to augment the ANSI/AAMI/ISO 11135 series (ethylene oxide sterilization) and is commonly used alongside related AAMI standards and TIRs addressing sterilization and sterility assurance.

Q: What are the key keywords?

A: Ethylene oxide, EO sterilization, product adoption, process equivalence, parametric release, validation extension, sterility assurance, medical devices.