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Designation: E1766 − 15
Standard Test Method for
Determination of Effectiveness of Sterilization Processes for
Reusable Medical Devices1
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.
1. Scope sterilization process being tested. A minimal recovery of 106
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
(instruments). This test method is not designed to validate a 1.6 Results of the recovery control and process test cycle are
sterilization process, but tests an established sterilization cycle compared to determine the effectiveness of the sterilization
or process. It is a practical test of the effectiveness of a process.
sterilization process applied to reusable medical devices. Bac- 1.7 Results of the recovery control and applied inoculum are
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.
Commercially available liquid suspensions of bacterial spores 1.8 The procedure should reveal that tested devices are free
are used to inoculate the instruments. of recoverable microorganisms when five or more consecutive
tests are conducted.
iTeh Standards
1.2 This test method is intended for reusable medical
devices cleaned in accordance with the device manufacturer’s
1.9 A knowledge of microbiological techniques is required
to conduct these procedures.
instructions and prepared for sterilization in accordance with
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the instructions for the sterilization process being used. 1.10 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.3 This test method assumes that cleaned, reusable medical
Document
devices will be free of visible soil but may have remaining Preview
adherent bioburden. A worst-case bioburden can be represented
standard.
1.11 This standard does not purport to address all of the
by suspensions of bacterial endospores, which are commer- safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
cially available for monitoring chemical or physicalASTM E1766-15
steriliza-
priate safety and health practices and determine the applica-
tion processes. These endospores should have a verifiable
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resistance (D value) to the specific process and sterilant being bility of regulatory limitations prior to use.
2
evaluated. 2. Referenced Documents
1.4 It is impractical to test for the sterility of some devices 2.1 ASTM Standards:3
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, or swabbing techniques are used to recover test 2.2 Other:
organisms from inoculated devices. ASTM Poster Presentation : “Use Verification of a Proposed
1.5 A recovery control will be included by inoculation of a Draft ASTM Standard to Determine the Efficacy of
test device and use of the elution methods without applying the Sterilization Techniques for Reusable Medical Instru-
ments” Presented at the E35.15 Subcommittee meeting in
Montreal, Canada
1
This test method is under the jurisdiction of ASTM Committee E35 on 3. Terminology
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents. 3.1 Definitions:
Current edition approved May 1, 2015. Published December 2015. Originally
approved in 1995. Last previous edition approved in 2007 as E1766 – 95 (2007).
3
DOI: 10.1520/E1766-15. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
2
Oxborrow, G. S., and Berube, R., “Sterility Testing—Validation of Sterilization contact ASTM Customer Service at [email protected]. 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
1
E1766 − 15
3.1.1 bioburden—the number and types of viable microor- 4.3 After inoculation, and drying, if required, the device is
ganisms that contaminate a device. prepared and processed according to the sterilant or sterilizer
3.1.2 CFU—colony-forming unit. manufacturer’s instructions.
3.1.3 inoculum—the number (usually specified as CFUs) 4.4 Following the sterilization process, the test devices are
and type (genus and species) of viable microorganisms used to sampled using specified elution techniques to recover any
contaminate a given sample or device. surviving spores.
3.1.4 sporicidal agent—any chemical or physical agent that
kills spores. 5. Significance and Use
3.1.5 sterilant—any sterilizing agent. 5.1 The test method is designed to demonstrate that all
3.1.6 sterile—a state of being free of living organisms. accessible surfaces and internal recesses or lumina of previ-
ously cleaned, reusable medical devices can be rendered free of
3.1.7 sterilization cycle or process—a physical or chemical
recoverable microorganisms when processed in a specified
process that has been demonstrated to meet applicable criteria
sterilizer cycle.
for sterilization as defined by AAMI.4
3.1.8 sterilizer—any device using a chemical or physical 5.2 Surviving spores are recovered by swabbing, brushing,
process that produces sterile materials. or irrigating with an elution fluid. Recovery methods may be
enhanced by mechanical action, sonication, and repeated
3.2 Definitions of Terms Specific to This Standard: flushing with elution fluid.
3.2.1 applied inoculum—the estimated count of the suspen-
sion of bacterial spores expressed as CFU/mL used to inoculate NOTE 1—The spore inoculation technique described in this test method
the test devices. This value may be used if the efficiencies of is only one of the available procedures for testing the sterilization of
devices. Spores on paper strips (biological indocators) are a traditional
the recovery methods are determined. tool used to develop and monitor sterilization cycles and are also
3.2.2 process test cycle—a complete sterilization cycle that appropriate for the evaluation of sterilization of medical devices.5
uses all parameters of the sterilization process as dictated by
iTeh Standards
the manufacturer. 6. Apparatus
3.2.3 recovery control—the CFU recoverable from a device 6.1 Syringes, 10 to 50 mL, sterile.
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following inoculation and optional drying of the spore suspen-
sion in or on the unprocessed device. The recovery of ≥106 6.2 Sterile Cotton Swabs.
CFUs per device is required. 6.3 Sterile Petri Dishes.
Document Preview
3.2.4 recovery effıciency—a measure of the recovery of
inoculated organisms from a device may be determined when
6.4 Sterile Test Tubes, to hold 10 mL.
necessary. The recovery efficiency may be expressed as the 6.5 Sterile Glass Bottles, to hold 50 mL.
ratio of the CFU from the recovery control compared ASTM E1766-15
to the
6.6 Steam Sterilizer.
CFU of the applied inoculum. This value is multiplied by 100
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to express efficiency as a percent. It is recommended that a 6.7 Water Bath, 48 6 2°C.
minimum of three tests be performed when estimating recovery
6.8 Incubator(s), 35 6 2°C and 55 6 2°C.
efficiency.
3.2.5 reusable medical devices—any medical device that is 6.9 Colony Counter.
claimed to be usable after reprocessing. 6.10 Medical Device, precleaned in accordance with the
3.2.6 spore—a bacterial endospore. (Strain identification manufacturer’s instructions.
and the means used to identify whether the vegetative or spore
6.11 Disposable or Reusable Membrane Filter Apparatus,
state is present should be indicated.)
sterile, 0.45-µm pore size.
3.2.7 worst-case—the intentional exaggeration of one or
more parameters of a test compared to normal clinical condi- 6.12 Micropipette, calibrated to dispense 5 to 20 µL.
tions. 6.13 Other devices or apparatus specified by the sterilant,
medical device, or sterilizer manufacturer.
4. Summary of Test Method
4.1 Percent recovery of inoculum may be used to ensure 7. Reagents
reproducible inoculation and recovery techniques. 7.1 Purity of Reagents—Reagent grade chemicals shall be
4.2 The test method is performed by contaminating the used in all tests. Unless otherwise indicated, it is intended that
cleaned reusable medical device with a bacterial endospore all reagents conform to the specifications of the Committee on
suspension. Analytical Reagents of the American Chemical Society where
4 5
See “Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices” United States Pharmacopeia, XXIII, or current edition, Rand McNally,
(ST27), AAMI, Arlington, VA, 1992, for typical criteria. Taunton, MA, 1995, pp. 200–206.
