Logo
Login Sign Up
Current Revision

AAMI TIR12:2020/(R)2023

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Best Price Guarantee
Instant

$285.00

2-5 Days

$285.00

SAVE 10%

$513.00


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


or
Assoc. for the Advancement of Medical Instrumentation Logo

AAMI TIR12:2020/(R)2023

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

PUBLISH DATE 2023
AAMI TIR12:2020/(R)2023
This technical information report (TIR) 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. In addition, greater detail is provided about the processes and resources that a health care facility can have for processing devices. This should provide further assistance to medical device manufacturers (MDMs) in developing their processing instructions. Health care personnel have the responsibility to obtain and review manufacturers— data and recommendations and to ensure that they have the necessary resources to follow manufacturers— instructions thoroughly. This TIR can serve as a resource for identifying the questions health care personnel should ask manufacturers when considering a product for purchase or when devising a processing protocol for a product already being used.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR12
Publication Date Jan. 1, 2023
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2023 Revision