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AAMI - TIR12

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

inactive
Organization: AAMI
Publication Date: 1 January 2010
Status: inactive
Page Count: 65
scope:

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. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately.

b) Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel.

c) Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products.

d) Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend for their products.

This TIR also includes definitions of terms, a list of references, and annexes providing supplementary information.

Exclusions

This TIR does not cover the following topics:

a) the design, testing, and labeling of reusable textiles (see ANSI/AAMI PB70),

b) the design, testing, and labeling of devices intended and labeled for single use, or

c) the design, testing, and labeling of containment devices for reusable medical devices (see ANSI/AAMI ST77).

Although this TIR refers to water quality for cleaning and other elements of reprocessing, it does not address methods of producing or ensuring adequate water quality (see AAMI TIR34).

Document History

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...
TIR12
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 Device 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 Manufacturers
A description is not available for this item.

References

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