ASTM_D_8179_-_18.pdf

Designation:D817918Standard Guide forCharacterizing Detergents for the Cleaning of Clinically-used Medical Devices1This standard is issued under the fixed designation D8179;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 Detergents play a critical role in the cleaning ofclinically-used medical devices,but there are few consensusmethods for describing the key characteristics of these deter-gents.This guide identifies consensus standards,ASTM andothers,used to characterize detergents in other applications,which can also be used to characterize detergents used to cleanclinically-used medical devices.1.2 In identifying these test methods,manufacturers ofdetergents can reference this guide to characterize their deter-gents.1.3 By identifying applicable test methods,gaps may beidentified where development of new standardized test meth-ods need to be developed to characterize detergents intended toclean medical devices.1.4 By identifying applicable test methods that are used andresults reported by detergent manufacturers,test results can beshared and may lead in the future to development of perfor-mance criteria for the key characteristics of detergent.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 Exclusions:1.6.1 This guide is not intended for detergents formulated toremove residues as a result of the manufacturing process.1.6.2 This guide does not provide information related todisinfection or disinfecting agents that might be part of adetergent formulation.1.7 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.1.8 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:2D459 Terminology Relating to Soaps and Other DetergentsD471 Test Method for Rubber PropertyEffect of LiquidsD543 Practices for Evaluating the Resistance of Plastics toChemical ReagentsD820 Test Methods for Chemical Analysis of Soaps Con-taining Synthetic DetergentsD1172 Guide for pH of Aqueous Solutions of Soaps andDetergentsD2024 Test Method for Cloud Point of Nonionic SurfactantsD3048 Test Method of Assay for Alkaline ProteaseD3519 Test Method for Foam in Aqueous Media(BlenderTest)(Withdrawn 2013)3D3601 Test Method for Foam In Aqueous Media(BottleTest)(Withdrawn 2013)3D7225 Guide for Blood Cleaning Efficiency of Detergentsand Washer-DisinfectorsE2454 Guide for Sensory Evaluation Methods to Determinethe Sensory Shelf Life of Consumer ProductsF2809 Terminology Relating to Medical and Surgical Mate-rials and DevicesF2847 Practice for Reporting and Assessment of Residueson Single-Use Implants and Single-Use Sterile Instru-mentsF3208 Guide for Selecting Test Soils for Validation ofCleaning Methods for Reusable Medical DevicesF3293 Guide for Application of Test Soils for the Validationof Cleaning Methods for Reusable Medical DevicesG31 Guide for Laboratory Immersion Corrosion Testing ofMetals1This guide is under the jurisdiction of ASTM Committee D12 on Soaps andOther Detergents and is the direct responsibility of Subcommittee D12.15 onPhysical Testing.Current edition approved Sept.1,2018.Published September 2018.DOI:10.1520/D8179-18.2For 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.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 G122 Test Method for Evaluating the Effectiveness ofCleaning Agents2.2 AAMI Documents:4AAMI TIR12:2010 Designing,testing,and labeling reusablemedical devices for reprocessing in health care facilities:A guide for medical device manufacturersAAMI TIR30:2011 A compendium of processes,materials,test methods,and acceptance criteria for