AAMI規格 AAMI TIR63, 2014: Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection, 滅菌または高水準消毒を必要とする、クリティカルおよびセミクリティカルな貸与された医療機器の管理

AAMI規格 TIR63, 2014/(R)2023

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AAMI規格 TIR63, 2014/(R)2023

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書名

AAMI TIR63, 2014: Management of loaned critical and semi-critical medical devices that require sterilization
or high-level disinfection (Includes all amendments and changes through Reaffirmation Notice , 2023)
AAMI規格 TIR63, 2014: 滅菌または高水準消毒を必要とする、クリティカルおよびセミクリティカルな
貸与された医療機器の管理
発行元 Association for the Advancement of Medical Instrumentation (AAMI)
発行年/月 2023年1月   
装丁 ペーパー
ページ数 16 ページ
発送予定 海外倉庫よりお取り寄せ 1-2週間以内に発送します
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Description

General
This TIR identifies the necessary steps to effectively manage medical devices not owned by the health care facility in which they are used.

Inclusions
This TIR addresses the management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection by the receiving facility prior to patient use. This document includes processes for the request, receipt, return, and documentation of loaned medical devices. Included are the roles and responsibilities of the health care facility ("receiver"), the lending entity ("sender"), and individuals.

Exclusions
This TIR does not address department design considerations, personnel considerations, cleaning and other decontamination processes, packaging, preparation, or sterilization (see ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST41, Ethylene oxide sterilization in health care facilities: Safety and effectiveness; and ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities). Processes for management of non-critical loaned medical devices and single-use medical devices, as well as off-site reprocessing facilities, are outside the scope of this document.