ASTM International - ASTM D7225-13(2019)e1
Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
|Publication Date:||1 May 2019|
|ICS Code (Analysis of blood and urine):||11.100.30|
significance And Use:
4.2 Use-The regular, periodic use of the blood soil test is a systemic challenge to the functioning of an automated washer. To properly challenge the cleaning device, the test must be analogous to the dried blood soil, to the stainless steel substrate, and to the physical barriers presented by surgical instruments. These physical barriers include the box lock, or pivot joint of a hinged instrument, the serrated tips, and crevices of surgical instruments. On the test coupon, the components of blood are similar to the state of dried blood on instruments. By utilizing a grooved stainless steel coupon, the substrate is similar to that of stainless steel instruments. By mounting the soiled coupon in a plastic holder the physical barriers represented by cracks and crevices of instruments (for example, box locks) are represented. Users are provided with an interpretation guide that aids them in interpreting results that are less than optimal. For instance, failure to remove the fibrin layer of blood soil (which is water insoluble) indicates a problem with the chemical cleaning agent(s). Failure to evenly remove a hemoglobin soil indicates a mechanical failure. Failure to remove any soil indicates either a catastrophic mechanical failure, or inappropriate settings for the initial rinse stage. As a standardized challenge, the test provides a reproducible means for the washer manufacturer and the detergent manufacturer to compare new designs and formulations to those existing within their own product line as well as those of others in the market. For the purpose of submitting their instructions for use, the test provides a means to validate the performance of their product with a device that is a surrogate for the devices their products will be used to clean in the practical setting. This validation testing can be used as part of any necessary documentation for regulatory filings and records.View Less
1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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.
1.4 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.