ANSI AAMI ST98-2022 PDF

Full title and description

ANSI/AAMI ST98:2022 — Cleaning validation of health care products — Requirements for development and validation of a cleaning process for medical devices. This standard establishes requirements and informative guidance for manufacturers to develop, test and document validated cleaning processes for medical devices that require processing before clinical use.

Abstract

ST98:2022 provides a requirements-based approach to cleaning validation for medical devices. The normative section lists mandatory elements for a cleaning validation program (product families, process definition, test soil selection and application, controls, test method validation, sample size, and endpoints) while the informative section offers guidance and examples to help manufacturers apply the requirements in practice. The document broadens and replaces the prior AAMI technical information report (TIR30) by converting guidance into formal, auditable requirements for device manufacturers.

General information

• Status: Current (published standard; replaces AAMI TIR30).
• Publication date: May 20, 2022 (ANSI/AAMI ST98:2022).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI); ANSI-designated American National Standard.
• ICS / categories: Health care technology — Medical equipment (11.040) and Sterilization & disinfection (11.080).
• Edition / version: ANSI/AAMI ST98:2022 (first edition as an ANSI/AAMI standard, superseding AAMI TIR30:2011/(R)2016).
• Number of pages: 41 pages; ISBN 978-1-57020-852-2.

Scope

Applies to the development and validation of cleaning processes for medical devices that require processing before each clinical use (per the Spaulding categorizations), including reusable devices and single‑use devices that are processed by a healthcare facility prior to use. ST98 sets requirements for how manufacturers should define cleaning processes, select and apply clinically relevant test soils, simulate use and worst‑case conditions, validate test methods, define sample sizes and establish endpoints to demonstrate that the cleaning instructions reliably produce a clean device suitable for downstream disinfection or sterilization.

Key topics and requirements

• Product family definitions and worst‑case selection for validation studies.
• Formal cleaning process definition (equipment, detergents, parameters, and IFU language).
• Selection and preparation of clinically relevant test soils and methods for soiling devices for validation testing.
• Controls, sample preparation, simulation of use, and worst‑case conditions for internal and external device features.
• Validation and verification of analytical test methods used to detect residual soil or markers.
• Statistically justified sample sizes and acceptance criteria for validation studies.
• Defined endpoints for cleaning validation that demonstrate the process achieves the intended removal of soil prior to disinfection or sterilization.
• Normative requirements supplemented by an informative guidance section with examples and practical recommendations.

Typical use and users

Primary users are medical device manufacturers — especially validation engineers, design for reprocessing teams, regulatory affairs and quality professionals — who must provide validated cleaning instructions in device labeling and premarket submissions. Secondary users include third‑party contract testing laboratories, clinical engineering/reprocessing specialists, healthcare facility sterilization and reprocessing teams, and regulatory reviewers. The standard is used to design validation protocols, prepare supporting reports for regulatory filings, and to update IFU and reprocessing instructions.

Related standards

Key related documents and standards include AAMI TIR30 (the technical information report that ST98 replaces), ANSI/AAMI ST79 (comprehensive guide to steam sterilization and sterility assurance in healthcare facilities), ANSI/AAMI ST91 (endoscope processing guidance) and the FDA final guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (2015), which informed validation concepts in ST98. Manufacturers commonly apply ST98 in conjunction with relevant device‑specific standards and national regulatory guidance for reprocessing and sterilization.

Keywords

cleaning validation, reprocessing, medical devices, test soil, instructions for use (IFU), validation protocol, product family, cleaning endpoint, sterilization preparation, AAMI ST98.

FAQ

Q: What is this standard?

A: ANSI/AAMI ST98:2022 is a requirements‑based standard for cleaning validation of health care products that defines what manufacturers must do to develop, validate and document cleaning processes for medical devices.

Q: What does it cover?

A: It covers the scope and mandatory elements of cleaning validation protocols: product family selection, cleaning process descriptions, test soil selection and application, simulation of use and controls, analytical test method validation, sample sizing and pass/fail endpoints, plus informative guidance on applying those requirements.

Q: Who typically uses it?

A: Medical device manufacturers (validation, quality, design and regulatory teams), contract testing labs, reprocessing specialists, and healthcare facility sterilization/reprocessing staff use the standard to design and evaluate cleaning validation programs and IFU reprocessing instructions.

Q: Is it current or superseded?

A: ST98:2022 is the current ANSI/AAMI standard (published in 2022) and supersedes AAMI TIR30:2011/(R)2016 by converting the prior TIR guidance into formal requirements for manufacturers.

Q: Is it part of a series?

A: ST98 sits within AAMI’s portfolio of sterilization, reprocessing and device‑processing standards and works alongside documents such as ST79 (steam sterilization), ST91 (endoscope processing) and other AAMI TIRs/guidance that address related topics. It is not a multi‑part numbered series but is frequently referenced together with these companion documents.

Q: What are the key keywords?

A: Cleaning validation, reprocessing, test soil, product family, IFU, cleaning endpoint, validation protocol, analytical method validation.