AAMI TIR28-2016 PDF

Full title and description

AAMI TIR28:2016 — Product adoption and process equivalence for ethylene oxide sterilization. This Technical Information Report (TIR) provides guidance for adopting new or modified medical device products into an existing validated ethylene oxide (EO) sterilization process and for determining equivalence of an EO sterilization process when conducted with different equipment. It is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

Abstract

This TIR explains principles and practical considerations for evaluating whether a new or modified product may be processed using an established EO sterilization cycle (product adoption) and for assessing whether sterilization performed in different equipment or under different but controlled conditions is equivalent (process equivalence). Topics include evaluation criteria, test and validation approaches, load configuration and packaging influences, documentation expectations, and a guide (annex) for product evaluation within an EO product family or processing category.

General information

• Status: Published; original publication 2016; subsequently reaffirmed (document maintained/reaffirmed by AAMI).
• Publication date: 18 November 2016
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI)
• ICS / categories: 11.080 (Sterilization and disinfection) — Health care technology / Sterilization
• Edition / version: Technical Information Report (TIR), 2016 edition (AAMI TIR28:2016); subject to reaffirmations/amendments
• Number of pages: 22

Scope

AAMI TIR28:2016 provides non-normative guidance for manufacturers, sterilization providers, and validation teams on (a) adopting new or modified products into an existing validated EO sterilization process and (b) determining whether sterilization performed using different equipment or under different controlled conditions achieves equivalent outcomes. The report supplements the ANSI/AAMI/ISO 11135 series and focuses on practical evaluation, test approaches, and documentation needed to support claims of product adoption or process equivalence for devices processed by ethylene oxide.

Key topics and requirements

• Principles for product adoption into an existing validated EO sterilization process (risk- and evidence-based evaluation).
• Criteria and approaches for demonstrating process equivalence across different sterilization equipment or configurations.
• Guidance on testing, validation studies, and data needed to support adoption or equivalence decisions (bioburden, biological indicators, parametric data where applicable).
• Consideration of product characteristics, packaging, load configuration, and process parameters that affect EO efficacy.
• Documentation, traceability, and recordkeeping practices to support validation and regulatory review.
• Annex A: a practical guide for evaluation of a product for adoption into an EO product family or processing category.

Typical use and users

Used by medical device manufacturers, sterilization validation engineers, quality assurance and regulatory affairs professionals, contract sterilization facilities, and clinical engineers. Typical applications include assessing whether a design change requires new validation, qualifying contract sterilizers or new equipment, preparing supporting data for regulatory submissions, and establishing internal procedures for parametric or conventional product release in EO sterilization.

Related standards

Mainly intended to complement ANSI/AAMI/ISO 11135 (ethylene oxide sterilization — validation and routine control). Other related AAMI guidance documents include TIR14 (contract sterilization using EO), TIR15 (physical aspects of EO sterilization), and TIR16 (microbiological aspects of EO sterilization). National or international sterilization validation standards and regulatory guidance on sterilization validation and device changes are also relevant.

Keywords

ethylene oxide, EO sterilization, product adoption, process equivalence, sterilization validation, parametric release, AAMI TIR28, medical device sterilization, validation documentation

FAQ

Q: What is this standard?

A: AAMI TIR28:2016 is a Technical Information Report that provides guidance on adopting products into existing EO sterilization processes and on assessing process equivalence when sterilization is performed with different equipment or controlled conditions.

Q: What does it cover?

A: It covers evaluation criteria, testing and validation approaches, factors that influence EO sterilization effectiveness (product, packaging, load configuration, equipment differences), and documentation practices. It includes an annex with a guide for product evaluation within an EO product family or processing category.

Q: Who typically uses it?

A: Medical device manufacturers, sterilization validation engineers, contract sterilizers, quality and regulatory personnel, and anyone responsible for demonstrating that a product change or a different sterilization setup is acceptable for EO processing.

Q: Is it current or superseded?

A: The report was published on 18 November 2016 as AAMI TIR28:2016. The document has been maintained by AAMI and may have been reaffirmed; users should check AAMI's catalogue or the most recent AAMI product listings to confirm the document’s current status before relying on it for compliance activities.

Q: Is it part of a series?

A: Yes. It is part of AAMI's body of guidance on ethylene oxide sterilization and is intended to augment the ANSI/AAMI/ISO 11135 series. It is associated with other EO-related TIRs (for example, TIR14, TIR15, and TIR16) that address contract sterilization, physical aspects, and microbiological aspects of EO sterilization.

Q: What are the key keywords?

A: Ethylene oxide; EO sterilization; product adoption; process equivalence; sterilization validation; parametric release; AAMI TIR28.