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AAMI TIR12

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

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Organization: AAMI
Publication Date: 1 January 2020
Status: active
Page Count: 73
scope:

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.

Document History

AAMI TIR12
January 1, 2020
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
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...
January 1, 2010
Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
Inclusions The scope of this TIR includes the following topics: a) Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device....
January 1, 2004
Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers
Inclusions The scope of this TIR includes the following topics: a) Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device....
January 1, 1994
Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Manufacturers
A description is not available for this item.
January 1, 1994
Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers
A description is not available for this item.

References

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