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
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
This TIR also includes definitions of terms, a list of
references, and annexes providing supplementary information.
This TIR does not cover the following topics:
a) the design, testing, and labeling of reusable textiles (see
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).
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