ASTM International - ASTM F3357-19

Standard Guide for Designing Reusable Medical Devices for Cleanability

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Organization: ASTM International
Publication Date: 1 August 2019
Status: active
Page Count: 7
significance And Use:

4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is... View More

scope:

1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).

1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Document History

ASTM F3357-19
August 1, 2019
Standard Guide for Designing Reusable Medical Devices for Cleanability
4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential...
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