• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

ASTM E 1766 : 2015 : REDLINE

Current
Current

The latest, up-to-date edition.

Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
Available format(s)

PDF

Language(s)

English

Published date

01-05-2015

CONTAINED IN VOL. 11.05, 2015 Defines a reproducible procedure for testing processes used to sterilize reusable medical devices (instruments).

1.1This 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.

1.2This 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.

1.3This 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

1.4It 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.

1.5A 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.

1.6Results of the recovery control and process test cycle are compared to determine the effectiveness of the sterilization process.

1.7Results of the recovery control and applied inoculum are compared to determine the recovery efficiency, if desired.

1.8The procedure should reveal that tested devices are free of recoverable microorganisms when five or more consecutive tests are conducted.

1.9A knowledge of microbiological techniques is required to conduct these procedures.

1.10The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.11This 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.

Committee
E 35
DocumentType
Redline
Pages
5
PublisherName
American Society for Testing and Materials
Status
Current

ASTM E 2314 : 2003 : R2014 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) (Withdrawn 2021)
ASTM E 2314 : 2003 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E 2314 : 2003 : R2008 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

View more information
£55.10
Excluding VAT

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.