1、Designation:F329318Standard Guide forApplication of Test Soils for the Validation of CleaningMethods for Reusable Medical Devices1This standard is issued under the fixed designation F3293;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revisi
2、on,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 provides methods and considerations forsimulated soiling of reusable medical devices for the purp
3、oseof validating cleaning instructions.Techniques for applicationof soil,as well as incorporation of soil by various means(e.g.,actuation of devices)will be described in order to assureworst-case contamination of the surface geometry of medicaldevices.1.2 UnitsThe values stated in SI units are to be
4、 regardedas standard.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 practi
5、ces 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 R
6、ecom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterD7225 Guide for Blood Cleaning Efficiency of Detergentsand Washer-DisinfectorsF2809 Terminology Relating to Medical and Surgi
7、cal Mate-rials and DevicesF3208 Guide for Selecting Test Soils for Validation ofCleaning Methods for Reusable Medical Devices2.2 AAMI Standards:3AAMI TIR30 A compendium of processes,materials,testmethods,and acceptance criteria for cleaning reusablemedical devicesAAMI ST79 Comprehensive guide to ste
8、am sterilization andsterility assurance in health care facilities2.3 ISO Standard:4ISO 10993-12 Biological evaluation of medical devicesPart 12:Sample preparation and reference materials2.4 Other References:ANSI/ASHRAE/ASHE Standard 170-2013 Ventilation ofhealth care facilities;Atlanta:ASHRAE,2013b5
9、Guidance for Industry and FDAStaff,Processing/Reprocess-ing Medical Devices in Health Care Settings:ValidationMethods and Labeling,201563.Terminology3.1 For definitions of terms in this Guide relating to the useof test soils for cleaning validation,refer to the TerminologySection of ASTM F3208.4.Sum
10、mary of Practice4.1 The standard provides details on the application(inocu-lation)of the test soil for testing,evaluation,and validation ofcleaning procedures.It includes:4.2 The methods for soiling a medical device.4.3 The selection of the appropriate method(s)for soiling adevice based upon clinica
11、l use of the device.4.4 Identification of area(s)of the device to soil based uponworst-case clinical use and device design.4.5 Establishing the dwell time for the soiled device,prior tobeginning cleaning procedures,based upon worst-case clinicalconditions/practice.1This practice/guide is under the j
12、urisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.15 on Material Test Methods.Current edition approved May 1,2018.Published May 2018.DOI:10.1520/F3293-18.2For referenced ASTM standards,visit the ASTM website,www.astm.or
13、g,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from Association for the Advancement of Medical Instrumentation(AAMI),4301 N.Fairfax Dr.,Suite 301,Arlington,VA 22203-16
14、33,http:/www.aami.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5https:/www.ashrae.org/resources-publications/bookstore/health-care-facilities-resources6www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/gui
15、d-ancedocuments/ucm253010.pdfCopyright 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
16、 theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 4.6 Identification of other worst-case clinical use conditionsthat represent a worst-case challenge to cleaning the device.These conditions could include the length of the procedure,condition of the patient,and/or extraordinary uses of the device(in compliance with the intended use of the device as estab-lished by the medical device manufacturer
