Cleaning Validation of Health Care Products — Requirements for Development and Validation of a Cleaning Process for Medical Devices
The American National Standard setting requirements for how a medical device manufacturer develops and validates the cleaning process it puts in its reprocessing instructions for reusable devices. Where its predecessor, AAMI TIR30, surveyed cleaning test methods, ST98 states requirements — for product families, the cleaning process definition, test soils and their application, simulated use and controls, test method validation, sample size, and cleaning endpoints.
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Scope & applicability
Manufacturers of medical devices that must be cleaned before clinical use, including devices processed by the health care facility. It governs the manufacturer's validation of the instructions it supplies; the facility's execution of those instructions is covered by AAMI's health care processing standards such as ST79.
Key requirements
- Grouping devices into product families with a justified worst case for validation
- A defined cleaning process, written as the instructions the user will follow
- Test soil selected and applied to represent clinical use, with simulated use and controls
- Validated test methods, a justified sample size, and predefined cleaning endpoints
Implementation tips
- Validate the instructions exactly as they will be printed — a cleaning step validated in the lab but worded differently in the IFU is not the validated process
Revision notes
Published in 2022 as a requirements standard, moving AAMI's cleaning-validation work out of the technical information report TIR30.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
ANSI/AAMI ST98:2022: frequently asked questions
Quick answers to common questions about ANSI/AAMI ST98:2022.
What is ANSI/AAMI ST98:2022?
ANSI/AAMI ST98:2022 — Cleaning Validation of Health Care Products — Requirements for Development and Validation of a Cleaning Process for Medical Devices — is a standard issued by the Association for the Advancement of Medical Instrumentation (United States / International). The American National Standard setting requirements for how a medical device manufacturer develops and validates the cleaning process it puts in its reprocessing instructions for reusable devices. Where its predecessor, AAMI TIR30, surveyed cleaning test methods, ST98 states requirements — for product families, the cleaning process definition, test soils and their application, simulated use and controls, test method validation, sample size, and cleaning endpoints.
Who does ANSI/AAMI ST98:2022 apply to?
Manufacturers of medical devices that must be cleaned before clinical use, including devices processed by the health care facility. It governs the manufacturer's validation of the instructions it supplies; the facility's execution of those instructions is covered by AAMI's health care processing standards such as ST79.
What are the key requirements of ANSI/AAMI ST98:2022?
AAMI ANSI/AAMI ST98:2022 requires, among other things: Grouping devices into product families with a justified worst case for validation; A defined cleaning process, written as the instructions the user will follow; Test soil selected and applied to represent clinical use, with simulated use and controls; Validated test methods, a justified sample size, and predefined cleaning endpoints.
When was ANSI/AAMI ST98:2022 last updated?
The current version of ANSI/AAMI ST98:2022 dates from January 2022. Published in 2022 as a requirements standard, moving AAMI's cleaning-validation work out of the technical information report TIR30.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.