AAMI規格 AAMI TIR12, 2020(R)2023: Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, 医療施設での使用を目的とした医療機器の設計、試験、およびラベル付け: 機器製造業者のためのガイド
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Description
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.
Textile devices used in patient draping systems or surgical clothing that are covered in ANSI/AAMI PB70 [5], and medical devices specified by the manufacturer as single-use and not to be processed by the health care facility are not included in the scope of this document.