ASTM E1766-15
(Test Method)Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices (Withdrawn 2023)
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices (Withdrawn 2023)
SIGNIFICANCE AND USE
5.1 The test method is designed to demonstrate that all accessible surfaces and internal recesses or lumina of previously cleaned, reusable medical devices can be rendered free of recoverable microorganisms when processed in a specified sterilizer cycle.
5.2 Surviving spores are recovered by swabbing, brushing, or irrigating with an elution fluid. Recovery methods may be enhanced by mechanical action, sonication, and repeated flushing with elution fluid.
Note 1: The spore inoculation technique described in this test method is only one of the available procedures for testing the sterilization of devices. Spores on paper strips (biological indocators) are a traditional tool used to develop and monitor sterilization cycles and are also appropriate for the evaluation of sterilization of medical devices.5
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.
1.5 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.
1.6 Results of the recovery control and process test cycle are compared to determine the effectiveness of the sterilization process.
1.7 Results of the recovery control and applied inoculum are compared to determine the recovery efficiency, if desired.
1.8 The procedure should reveal that tested devices are free of recoverable microorganisms when five or more consecutive tests are conducted.
1.9 A knowledge of microbiological techniques is required to conduct these procedures.
1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.11 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.
WITHDRAWN RATIONALE
This test method covers a reproducible procedure for testing processes used to sterilize reusable medical devices (instruments).
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this test method was withdrawn in January 2023. This standard is b...
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1766 − 15
Standard Test Method for
Determination of Effectiveness of Sterilization Processes for
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Reusable Medical Devices
This standard is issued under the fixed designation E1766; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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1. Scope sterilization process being tested. A minimal recovery of 10
colony-forming unit (CFU)/mL per device is required for the
1.1 This test method covers a reproducible procedure for
recovery control.
testing processes used to sterilize reusable medical devices
1.6 Resultsoftherecoverycontrolandprocesstestcycleare
(instruments). This test method is not designed to validate a
compared to determine the effectiveness of the sterilization
sterilization process, but tests an established sterilization cycle
process.
or process. It is a practical test of the effectiveness of a
sterilization process applied to reusable medical devices. Bac-
1.7 Resultsoftherecoverycontrolandappliedinoculumare
terial spores more resistant to the test sterilant than the natural
compared to determine the recovery efficiency, if desired.
bioburden of the instrument are used as the test organisms.
1.8 The procedure should reveal that tested devices are free
Commercially available liquid suspensions of bacterial spores
of recoverable microorganisms when five or more consecutive
are used to inoculate the instruments.
tests are conducted.
1.2 This test method is intended for reusable medical
1.9 A knowledge of microbiological techniques is required
devices cleaned in accordance with the device manufacturer’s
to conduct these procedures.
instructions and prepared for sterilization in accordance with
1.10 The values stated in SI units are to be regarded as
the instructions for the sterilization process being used.
standard. No other units of measurement are included in this
1.3 This test method assumes that cleaned, reusable medical
standard.
devices will be free of visible soil but may have remaining
1.11 This standard does not purport to address all of the
adherentbioburden.Aworst-casebioburdencanberepresented
safety concerns, if any, associated with its use. It is the
by suspensions of bacterial endospores, which are commer-
responsibility of the user of this standard to establish appro-
cially available for monitoring chemical or physical steriliza-
priate safety and health practices and determine the applica-
tion processes. These endospores should have a verifiable
bility of regulatory limitations prior to use.
resistance (D value) to the specific process and sterilant being
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evaluated.
2. Referenced Documents
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1.4 It is impractical to test for the sterility of some devices
2.1 ASTM Standards:
by immersion in growth medium because of their complexity,
D1193 Specification for Reagent Water
size, and availability (for long-term incubation) or adverse
E1054 Test Methods for Evaluation of Inactivators of Anti-
effects on the devices from long-term immersion. Therefore,
microbial Agents
elution,rinsing,orswabbingtechniquesareusedtorecovertest
2.2 Other:
organisms from inoculated devices.
ASTM Poster Presentation : “Use Verification of a Proposed
Draft ASTM Standard to Determine the Efficacy of
1.5 A recovery control will be included by inoculation of a
Sterilization Techniques for Reusable Medical Instru-
test device and use of the elution methods without applying the
ments” Presented at the E35.15 Subcommittee meeting in
Montreal, Canada
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This test method is under the jurisdiction of ASTM Committee E35 on
3. Terminology
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
3.1 Definitions:
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved May 1, 2015. Published December 2015. Originally
approved in 1995. Last previous edition approved in 2007 as E1766 – 95 (2007).
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DOI: 10.1520/E1766-15. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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Oxborrow, G. S., and Berube, R., “SterilityTesting—Validation of Sterilization contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Processes, and Sporicide Testing,” Disinfection, Sterilization, and Preservation, Standards volume information, refer to the standard’s Document Summary page on
Block, S. S., 4th Edition, Lea and Febiger, Philadelphia, PA, 1991, pp. 1047–1058. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1766 − 15
3.1.1 bioburden—the number and types of viable microor- 4.3 After inoculatio
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