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ASTM E 1766 Document Information:
Title
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM International
Publication Date:
Nov 10, 1995
Scope:
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.
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.
This test method assumes that cleaned, reusable medical devices
will be free of visible soil but may have remaining adherent
bioburden.Aworst-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
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.
A recovery control will be included by inoculation of a test
device and use of the elution methods without applying the
sterilization process being tested. A minimal recovery of
106 colony-forming unit (CFU)/mL per device is required
for the recovery control.
Results of the recovery control and process test cycle are
compared to determine the effectiveness of the sterilization
process.
Results of the recovery control and applied inoculum are
compared to determine the recovery efficiency, if desired.
The procedure should reveal that tested devices are free of
recoverable microorganisms when five or more consecutive tests are
conducted.
A knowledge of microbiological techniques is required to conduct
these procedures.
The values stated in SI units are to be regarded as the
standard.
This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use.
2 Oxborrow, G. S., and Berube, R., "Sterility
Testing—Validation of Sterilization Processes, and Sporicide
Testing," Disinfection, Sterilization, and Preservation,
Block, S. S., 4th Edition, Lea and Febiger, Philadelphia, PA, 1991,
pp. 1047–1058.
Keywords:
- elution
- recovery
- reprocessing of medical devices
- reusable medical device
- sterilant
- sterilazation processes
- sterilizer
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