BH GSO ASTM E1766:2022
Bahraini Standard
Current Edition
·
Approved on
28 April 2022
·
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
BH GSO ASTM E1766:2022 Files
English
4 Pages
Current Edition
Reference Language
BH GSO ASTM E1766:2022 Scope
1.1 This test method covers a reproducible procedure for
testing processes used to sterilize reusable medical devices
(instruments). This test method is not designed to validate a
sterilization process, but tests an established sterilization cycle
or process. It is a practical test of the effectiveness of a
sterilization process applied to reusable medical devices. Bacterial spores more resistant to the test sterilant than the natural
bioburden of the instrument are used as the test organisms.
Commercially available liquid suspensions of bacterial spores
are used to inoculate the instruments.
1.2 This test method is intended for reusable medical
devices cleaned in accordance with the device manufacturer’s
instructions and prepared for sterilization in accordance with
the instructions for the sterilization process being used.
1.3 This test method assumes that cleaned, reusable medical
devices will be free of visible soil but may have remaining
adherent bioburden. A worst-case bioburden can be represented
by suspensions of bacterial endospores, which are commercially available for monitoring chemical or physical sterilization processes. These endospores should have a verifiable
resistance (D value) to the specific process and sterilant being
evaluated.2
1.4 It is impractical to test for the sterility of some devices
by immersion in growth medium because of their complexity,
size, and availability (for long-term incubation) or adverse
effects on the devices from long-term immersion. Therefore,
elution, rinsing, or swabbing techniques are used to recover test
organisms from inoculated devices.
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