AAMI TIR14-2016 PDF

Full title and description

AAMI TIR14:2016 — "Contract sterilization using ethylene oxide". This Technical Information Report provides guidance to augment ANSI/AAMI/ISO 11135 (ethylene oxide sterilization) specifically for medical device manufacturers that use contract sterilization services and for contract sterilization operations; it does not focus on ethylene oxide sterilization guidance for health care facilities.

Abstract

This TIR explains how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide (EtO) sterilization carried out at contract sterilization facilities for devices marketed in the United States, and offers practical guidance on selecting and working with contract sterilizers, validation and routine process control, sample handling, and documentation to support device manufacturers and contract sterilization operators.

General information

• Status: Current — AAMI TIR14:2016 with reaffirmations; listed as AAMI TIR14:2016/(R)2024 (reaffirmed).
• Publication date: Original publication June 5, 2016; reaffirmation/publication update March 26, 2024 (R2024).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: Health care technology — sterilization and disinfection (ICS 11.080) and related medical-device sterilization guidance.
• Edition / version: AAMI TIR14:2016 (with recorded revisions/reaffirmations R2020 and R2024 — current edition is the 2016 TIR as reaffirmed).
• Number of pages: Approximately 19–20 pages depending on edition/format; official listings for the R2024 active distribution show 20 pages while original 2016 listings commonly show 19 pages.

Scope

The document augments ANSI/AAMI/ISO 11135 requirements by providing practical, U.S.-oriented guidance for the use of contract ethylene oxide sterilization services. Topics include criteria for selecting a contract sterilizer, essential terms and responsibilities in written agreements between device manufacturers and contract sterilizers, requirements and expectations for validation programs, handling of biological indicators (BIs), process challenge devices (PCDs) and product samples, routine processing controls, and sterilization documentation needed to support regulatory and quality-system requirements. Health-care-facility EtO sterilization practices are explicitly not the primary focus.

Key topics and requirements

• Selection and qualification of contract sterilization facilities (capability, regulatory compliance, emissions controls where applicable).
• Written agreement elements between product manufacturer and contract sterilizer (roles, responsibilities, acceptance criteria, change control).
• Validation program expectations that align with ANSI/AAMI/ISO 11135: development, installation, performance qualification and ongoing revalidation.
• Handling, use and interpretation of biological indicators (BIs), process challenge devices (PCDs) and product samples used for validation and routine control.
• Sterilization processing documentation and records required for traceability, regulatory submissions and quality systems.
• Controls for routine processing including process parameters, monitoring, corrective actions and reporting between contract sterilizer and manufacturer.

Typical use and users

Primary users are medical device manufacturers that outsource EtO sterilization and the contract sterilization facilities that receive and process those devices. Secondary users include regulatory affairs personnel, quality and sterilization engineers, contract-review teams, supply-chain managers, and auditors who need to evaluate process validation, documentation and supplier controls related to EtO contract sterilization.

Related standards

This TIR is intended to be used with and to augment ANSI/AAMI/ISO 11135 (Sterilization of health care products — Ethylene oxide — Requirements for development, validation and routine control), and is associated with other AAMI TIRs on ethylene oxide such as AAMI TIR15 (physical aspects), TIR16 (microbiological aspects), TIR17 (compatibility of materials) and TIR28 (product adoption and process equivalence). Regulatory references and relevant guidance (FDA, EPA, and applicable national regulations) should also be consulted where required.

Keywords

ethylene oxide, EtO, sterilization, contract sterilization, AAMI TIR14, ISO 11135, validation, biological indicators, process challenge device, sterilization documentation, medical device sterilization, supplier qualification

FAQ

Q: What is this standard?

A: AAMI TIR14:2016 is a Technical Information Report titled "Contract sterilization using ethylene oxide" that provides guidance for device manufacturers and contract sterilization operations to apply ANSI/AAMI/ISO 11135 requirements in practice.

Q: What does it cover?

A: It covers selection and qualification of contract sterilizers, the content and expectations of written agreements, requirements for validation and routine control, handling of BIs/PCDs and product samples, process documentation, and routine monitoring and control practices for EtO contract sterilization. It is expressly intended to augment ISO 11135 rather than replace it.

Q: Who typically uses it?

A: Medical device manufacturers that outsource EtO sterilization, contract sterilization facilities, sterilization and quality engineers, regulatory and QA/QC personnel, and auditors or contract-review teams.

Q: Is it current or superseded?

A: The technical report was published in 2016 and has recorded reaffirmations; listings show the active/reaffirmed status as AAMI TIR14:2016/(R)2024 (current). Historical editions include versions from 2009 and earlier; check AAMI or authorized distributors for the exact edition and any future revisions.

Q: Is it part of a series?

A: Yes — it is one of several AAMI Technical Information Reports addressing ethylene oxide sterilization and associated topics (for example TIR15, TIR16, TIR17, TIR28) and is intended to be used alongside ANSI/AAMI/ISO 11135.

Q: What are the key keywords?

A: Ethylene oxide (EtO), contract sterilization, validation, biological indicators (BI), process challenge device (PCD), sterilization documentation, ISO 11135, manufacturer–contractor agreement, routine process control.