ASTM_D_7225_-_13_2019e1.pdf

Designation:D722513(Reapproved 2019)1Standard 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.1NOTEReferenced Documents were updated editorially in May 2019.1.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 Referenced DocumentsD5343,D4008,D4265,D2960,and D3050 in Section 2 foradditional 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D5343 Guide for Evaluating Cleaning Performance of Ce-ramic Tile CleanersD4008 Guide for Measuring Anti-Soil Deposition Propertiesof Laundry DetergentsD4265 Guide for Evaluating Stain Removal Performance inHome LaunderingD2960 Guide for Controlled Laundering Test Using Natu-rally Soiled Fabrics and Household Appliances(With-drawn 2013)3D3050 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/ISO 17664 Processing of health care prod-uctsInformation to be provided by the medical devicemanufacturer for the processing of 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 Washer-disinfectors,part 5:test soils andmethods for demonstrating cleaning efficacy of washer-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.1This 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 May 1,2019.Published May 2019.Originallyapproved in 2006.Last previous edition approved in 2013 as D7225 13.DOI:10.1520/D7225-13R19E01.2For 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 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