AAMI TIR12:2020(R2023)
Current
The latest, up-to-date edition.
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
English
07-09-2023
This document provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-779-2
|
| Pages |
73
|
| ProductNote |
This standard also refers to ISO 10993, ISO 15883-4
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| NEMA CS 70009:2025 | Cleaning and Disinfecting Guidance for Electrical Equipment |
| ANSI/AAMI ST58:2024 | Chemical sterilization and high-level disinfection in health care facilities |
| ANSI/AAMI/ISO 17664-1:2022 | Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices |
| ANSI/AAMI/ISO 17664-2:2022 | Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices |
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