ASTM_D_7225_-_13.pdf

Designation:D722513Standard Guide forBlood Cleaning Efficiency of Detergents and Washer-Disinfectors1This standard is issued under the fixed designation D7225;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is based on a standardized test soil correlat-ing to coagulated blood suitable for screening tests and theevaluation of the cleaning efficiency of washer-disinfectorsused for reprocessing of surgical instruments.This guidestrictly deals with cleaning and does not describe any methodsthat are related to disinfection.See the Referenced DocumentsD5343,D4008,D4265,D4488,D2960,D3050,in Section 2for additional information.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D5343 Guide for Evaluating Cleaning Performance of Ce-ramic Tile CleanersD4008 Test Method for Measuring Anti-Soil DepositionProperties of Laundry Detergents(Not Suitable for Deter-gent Ranking)D4265 Guide for Evaluating Stain Removal Performance inHome LaunderingD4488 Guide for Testing Cleaning Performance of ProductsIntended for Use on Resilient Flooring and WashableWalls(Withdrawn 2009)3D2960 Guide for Controlled Laundering Test Using Natu-rally Soiled Fabrics and Household AppliancesD3050 Guide for Measuring Soil Removal from ArtificiallySoiled Fabrics(Not Suitable for Detergent Ranking)2.2 AAMI Standards:4ANSI/AAMI ST79 Comprehensive guide to steam steriliza-tion and sterility assurance in health care facilitiesAAMI TIR 12 Designing,testing,and labelling reusablemedical devices for reprocessing in health care facilities:a guide for medical device manufacturersANSI/AAMI ST81 Sterilization of medical devices infor-mation to be provided by the manufacturer for theprocessing of resterilizable medical devicesAAMI TIR 30 A compendium of processes,materials,testmethods,and acceptance criteria for cleaning reusablemedical devices2.3 ISO Standards5ISO 158832 Washer-disinfectors,part 2:requirements andtests for washer-disinfectors employing thermal disinfec-tion for surgical instruments,anaesthetic equipment,bowls,dishes,receivers,utensils,glassware,etc.ISO/TS 158835:2005 Washer-disinfectors,part 5:test soilsand methods for demonstrating cleaning efficacy ofwasher-disinfectors3.Summary of Guide3.1 The standardized test soil is based on a proteinousmatrix containing fibrinogen and thrombin in two separatedcomponents.Coagulation and formation of fibrin fibers areinduced after mixing the two components.3.2 The suggested methods are based on the removal ofstandardized test soil as a result of mechanical or chemicalaction,or both,of the tested detergents or washer-disinfectors,or both.The screening test provides qualitative results forcleaning efficacy.After testing the practical situation in awasher-disinfector,the end result is visually checked forimmediate evaluation.Minor residue is detected by using the1This guide is under the jurisdiction of ASTM Committee D12 on Soaps andOther Detergents and is the direct responsibility of Subcommittee D12.16 on HardSurface Cleaning.Current edition approved June 1,2013.Published July 2013.Originally approvedin 2006.Last previous edition approved in 2006 as D7225 06.DOI:10.1520/D7225-13.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.5Available from International Organization for Standardization(ISO),1,ch.dela Voie-Creuse,CP 56,CH-1211 Geneva 20,Switzerland,http:/www.iso.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 peroxidase reaction.The quantitative test provides quantitativeresults for cleaning efficacy by providing measuring the re-moval of a known amount of protein.After placement of thetest coupon within a washer or in a beaker of water,the endresult is measured gravimetrically or by spectophotometerdetection of protein residue,or both.4.Significance and Use4.1 SignificanceDried blood represents a significant chal-lenge to cleaning surgical instruments.The water-solublecomponents of blood are easily rendered insoluble whene