1、Designation: F3293 18Standard 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 re
2、vision, 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 fo
3、r the purposeof 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 u
4、nits are to be 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
5、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 St
6、andards, Guides and Recom-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 Relat
7、ing to Medical and Surgical 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
8、 Comprehensive guide to steam 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 faci
9、lities; Atlanta: ASHRAE, 2013b5Guidance 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 Te
10、rminologySection of ASTM F3208.4. Summary 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 metho
11、d(s) for soiling adevice based upon clinical 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 clinicalcondition
12、s/practice.1This practice/guide is under the jurisdiction 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
13、 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.3Available from Association for the Advancement of Medical Instrumentation(A
14、AMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, 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-resources6w
15、ww.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guid-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 pri
16、nciples 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.14.6 Identification of other worst-case clinical use conditionsthat repres
17、ent 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).5. Significance and Use
18、5.1 This standard guide may be used by medical devicemanufacturers as part of their design plan and implementationof the validation of the cleaning instructions of their reusablemedical devices.5.2 It may help medical device manufacturers identify themost inaccessible locations on their device for i
19、noculation withclinically relevant, simulated-use test soil (see ASTM F3208),thereby allowing testing to evaluate whether or not the medicaldevice can be adequately cleaned.5.3 Methods described include pipetting, brushing,immersing, spraying, handling, and other techniques for apply-ing soil.5.4 Gu
20、idance is given as to how to identify the clinicallyrelevant areas of the device to soil, the time allowed for the soilto dry, and other conditioning considerations based uponassessment of worst-case clinical conditions.6. Determining the Volume to Soil Each Device6.1 The volume of test soil applied
21、 to a device should reflectworst-case clinical conditions.6.2 ISO 10993-12 provides formulas for calculating thesurface-to-area to volume ratios.6.3 AAMI TIR30 provides formulas for calculating thesurface area and volume of the internal channel of a device.6.4 Special attention should be paid to the
22、 volume of the keysoil markers (see ASTM F3208 for selection of test soil andsoil markers) applied. This should not only reflect worst-caseconditions, but also take into account expected recoveryefficiency and the level of detection of the test method.6.5 The method of application of soil (see Secti
23、on 9) willalso be a factor in the volume of test soil. For instance, if theentire device is to be immersed in the test soil (section 9.6),adequate volume of soil to accomplish this will be required.Another example is that if soiling involves perfusing internalchannels of the device with test soil, t
24、he volume of soil toaccomplish this must be calculated.6.6 Other considerations include the physical characteristicsof the test soil as it simulates clinical soiling (see ASTMF3208) including: Adhesion, Viscosity, and Solubility.7. Determining the Most Difficult Areas to Soil7.1 Special consideratio
25、n should be given to ensure inocu-lation of the most difficult locations on the medical device toclean (i.e. worst-case location) such as crevices, narrow dead-end lumens, stopcocks, etc. (see AAMI TIR30:2011 Section4.2 for list of difficult areas to clean).7.2 Locations on the device that could pot
26、entially be con-taminated during use should be considered for inoculation.8. Determining Clinically Relevant Worst-Case DryingTime8.1 General Considerations:8.1.1 Duration of time for the application of test soil: Aperiod of time should be established for the duration of theapplication of soil. The
27、length of time that the test device issubjected to soiling should reflect worst-case clinical use toensure that there is sufficient time to allow contaminants toadhere to and penetrate the device, thereby implementingworst-case soiling to the greatest degree practical.8.1.2 If after clinical use of
28、the device, drying of soil mightoccur and cleaning might not be performed immediately afteruse (such as with loaner devices that will be shipped withoutadequate reprocessing), the validation methods should allowsoils to dry for a length of time that simulates worst-case(longest) duration.8.1.3 To mi
29、nimize variability of soiling, consider removingexcess soil after soiling and before drying.8.1.4 The drying phase could be performed in a number ofways. The most common approach is to dry the devices at roomtemperature (20-25C) until the devices are not only visuallydry, but to the touch using a gl
30、oved hand. Alternative methodsto test the dryness of the soil include use of a dry cotton swab,toothpick, or similar tools.8.1.5 If flaking of soil occurs during drying an alternativetest soil or drying method should be used.8.1.6 Accelerated drying processes generally do not reflectconditions of no
31、rmal use and should be avoided. Methods toaccelerate the drying process (elevated temperature, low hu-midity) may be considered, but may also alter the test soil,rendering it easier to remove.8.2 Temperature and HumidityThe test soil should remainon the device/component and be allowed to dry in a te
32、mpera-ture and humidity range that is similar to that found inhealthcare facilities.8.3 Current published guidelines (ASHRAE 170) for envi-ronmental conditions in areas where a soiled device will dwellinclude the operating theater, the operating room and procedureroom.8.4 The length of time allowed
33、for drying should reflect theworst-case elapse of time that takes into consideration the timebetween patient use of the device (including the time during theclinical procedure when the device is no longer in-use) andreprocessing.8.4.1 In busy healthcare facilities, the limitations of equip-ment and
34、personnel can mean that hours elapse before cleaningprocedures begin.8.4.2 Reduced staffing on weekends can mean that cleaningprocedures are delayed by 24 or 48 hours.8.5 Point of Use TreatmentIn general, worst-case soilingand conditioning for validating cleaning should exclude pointof use pretreatm
35、ent of a device.8.6 Repeated SoilingSimulated use conditions for thevalidation studies should be considered, especially for deviceswith features at risk for the accumulation of soil with repeateduse. In such cases, validation studies should use devices thatF3293 182have undergone some simulated use.
36、 Validation studies shouldincorporate multiple full-use cycles (e.g., soiling, use, cleaning,and disinfection/sterilization) and should be designed to assessthe accumulation of soil over time. If the device is likely to berepeatedly subjected to “pushing” soil into a hard-to-reach areaduring use, va
37、lidation soiling should include repeated soiling toadequately reproduce such a worst-case use situation. Thenumber of simulated use cycles should be scientifically justi-fied.9. Application of Test Soil9.1 General ConsiderationThe test soil solution may beapplied to the surface of a medical device/c
38、omponent byvarious means. Selecting the method(s) for application of testsoil should be based upon the clinical use of the device and thedesign considerations discussed in Section 6. Simulated useconditions should account for real-world use conditions tomimic worst-case clinical use (e.g., the worst
39、-case duration ofclinical exposure). All functional procedures (such as repeatedarticulations, flexure manipulations) for which the device isintended should be conducted in order to soil the devicesufficiently to represent worst-case conditions should be con-ducted. Consideration should be given to
40、the soiling process toensure that reproducible contamination levels are achieved.Regardless of the chosen method, a defined surface area shouldbe inoculated with an amount of soil (usually expressed asug/cm2) so that the samples can be compared to the pre-definedcleaning specification.9.2 PipettingI
41、n this method, a defined amount of theselected test soil is pipetted onto a device. Using this method,soil can be pipetted on a desired area such as a lumen, boxlocks, hinges, crevices, or any surfaces of a device. Thisapplication method ensures that the user applies a specificamount of soil onto a
42、specific location on the device. Thismethod makes the soil application more reproducible. Forlumens, the entire lumen should be filled with test soil.Templates could also be used to evenly pipette the soil toassure a uniform layer of thickness will cover a defined surfacearea.9.3 Paint BrushingIn th
43、is method, the selected test soil isapplied to a medical device using a dedicated paint brush. Thisapplication method applies a variable amount of soil to aparticular location, and also varies the thickness of the soil coatat a particular location.9.4 SprayingIn this method, the selected test soil i
44、ssprayed onto a medical device using a sprayer. This soilapplication method is used for applying an even coat of thesimulated soil on test devices. This method is appropriate fordevices for which the exterior of the device is soiled. Anadditional soiling method should be used if there are surfaceare
45、as that can be soiled during clinical use that are notaccessible to spraying (e.g., the interior of the device).9.5 Handling with Soiled GlovesIn this method, the se-lected test soil is applied to the devices using soiled gloves. Anoperator dons the gloves and immerses the gloved hands in thetest so
46、il. Alternatively, a specified amount of test soil (Section6) can be pipetted onto each gloved finger. (The operator thenhandles and operates the device using soiled, gloved hands.The amount of soil, the thickness of the coat, and area ofsoiling differs at each application. The soil is applied uneve
47、nlyonto the device surfaces and often simulates handling ofspecific areas of the device during use, accounting for worst-case soiling of these devices.9.6 ImmersionIn this method, the device is immersed inthe selected test soil, using a sufficient volume of test soil. Thisway the soil is applied to
48、the entire device. If the immerseddevice has lumens and the soil is intended to perfuse theinterior of the lumen, soil is injected using a syringe and anappropriate connector if needed to fully infuse the lumen withan excess of soil. This soil application method ensures all theareas of the device co
49、me in contact with the soil. Partialimmersion of a device could also be applied to simulatedevices that are used in the body cavity where the distal end isfully immersed in bodily fluids and the proximal is not.9.7 FlushingIn this method, the lumens of medicaldevices/components can be perfused by flushing the test soilinto the channel using a syringe connected to an appropriatetubing connector. The entire lumen should be flushed with anexcess of test soil.9.8 VacuumIn this method, a vacuum is used to pull theselected test soil through the device. This method may beapp
