1、Designation: F3208 17Standard Guide forSelecting Test Soils for Validation of Cleaning Methods forReusable Medical Devices1This standard is issued under the fixed designation F3208; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t
2、he 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 describes methods for selecting test soils forcleaning validations based upon the characteristic
3、s of the soil,the physical characteristics of the device, and the clinical use ofthe device.1.2 This guide describes the preparation and use of sometest soils for the validation of cleaning instructions for reusablemedical devices.1.3 Reusable medical devices such as endoscopes, ar-throscopic shaver
4、s, surgical instruments, and suction tubes areexposed to biological soils during clinical use. Preparation ofthese devices for reuse requires cleaning and disinfectionand/or sterilization as applicable. Adequate cleaning is the firststep in a process intended to prevent contaminant transfer tothe ne
5、xt patient and medical practitioner. The soils, if inad-equately removed, can interfere with disinfection and steriliza-tion processes, as well as performance of the device. Accep-tance criteria are based either on a visual assessment orquantitatively specified marker(s) endpoint(s) of the soil orbo
6、th (ISO/TS 15883-5, Section 1). Endpoints after cleaningshould be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from thecontaminant during further handling, and endpoints for clean-ing established in the scientific literature.1.4 The test
7、 soils are designed to simulate the contaminantsthat medical devices are likely to come in contact with duringclinical use. The test soils discussed in this guide are a mixtureof constituents that simulate what is commonly found in humansecretions, blood, tissue, and bone fragments/shavings as wella
8、s non-patient derived soil (e.g., bone cement, lubricants, anddyes) during clinical procedures. The test soils also simulatethe physical parameters (e.g., viscosity, adhesion) of clinicalmaterial to which the medical devices will be exposed.1.5 Exclusion:1.5.1 This guide does not include methods to
9、validatecleaning processes to remove residues from manufacturing1.5.2 This guide does not describe the soil/inoculum usedfor validation of disinfection or sterilization instructions. Dis-infection or sterilization validation requires separate testingthat is independent of cleaning validation studies
10、.1.5.3 Test soils described are not intended for use by healthcare facilities to verify the effectiveness of their cleaningprocess.1.5.4 The test soil recipes are not intended to encompassevery biological residue with which a medical device is likelyto come into contact.1.6 Test soil formulations no
11、t described in this guide may beclinically relevant and may be more appropriate for simulated-use testing depending upon the clinical use of the medicaldevice. The burden is upon the medical device manufacturer todetermine and justify scientifically the selection of test soil(s).1.7 The values state
12、d in SI units are to be regarded as thestandard. No other units of measurement are included in thisstandard.1.8 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
13、and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D445 Test Method for Kinematic Viscosity of Transparentand Opaque Liquids (and Calculation of Dynamic Viscos-ity)D1193 Specification for Reagent WaterD3330/D3330M T
14、est Method for PeelAdhesion of Pressure-Sensitive TapeD3359 Test Methods for Measuring Adhesion by Tape TestD4212 Test Method for Viscosity by Dip-Type ViscosityCupsD4287 Test Method for High-Shear Viscosity Using a Cone/Plate Viscometer1This test method is under the jurisdiction of ASTM Committee F
15、04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Jan. 15, 2017. Published March 2017. DOI: 10.1520/F3208-17.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Cus
16、tomer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was deve
17、loped 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.1D7042 Test Method
18、for Dynamic Viscosity and Density ofLiquids by Stabinger Viscometer (and the Calculation ofKinematic Viscosity)D7225 Guide for Blood Cleaning Efficiency of Detergentsand Washer-DisinfectorsD7867 Test Methods for Measurement of the RotationalViscosity of Paints, Inks and Related Liquid Materials asa
19、Function of TemperatureF2809 Terminology Relating to Medical and Surgical Mate-rials and Devices2.2 AAMI Standards:3TIR12:2010 Designing, testing, and labeling reusable medi-cal devices for reprocessing in health care facilities: Aguide for medical device manufacturersTIR30:2011 A compendium of proc
20、esses, materials, testmethods, and acceptance criteria for cleaning reusablemedical devices2.3 ISO Standard:4ISO/TS 15883-5 Washer-disinfectorsPart 5: Test soils andmethods for demonstrating cleaning efficacy2.4 FDA Standard:5Reprocessing Medical Devices in Health Care Settings Vali-dation Methods a
21、nd LabelingGuidance for Industry andFood and Drug Administration Staff3. Terminology3.1 DefinitionsUnless provided otherwise in the follow-ing definitions, terminology shall be in conformance withTerminology F2809.3.1.1 cleaning, nremoval of contamination from a medi-cal device to the extent necessa
22、ry for further processing or forintended use.3.1.2 cleaning marker, nthat which is being detected/measured to determine soil removal/retention.3.1.3 contamination, nprocedure of applying simulatedtest soil onto a medical device for determination of processcapability (that is, cleaning efficacy and e
23、xtraction yields).3.1.4 test soil, nsingle substance or a mixture of sub-stances that reflect the contaminants likely to be encounteredduring the use of the device n its intended clinical procedure.3.1.5 validation, ndocumented procedure for obtaining,recording, and interpreting the results required
24、 to establish thata process will consistently yield results complying with prede-termined specifications.3.1.5.1 DiscussionUnder U.S. FDA guidelines, validationof the instructions for cleaning is the responsibility of themedical device manufacturer.4. Summary of Guide4.1 This guide provides informat
25、ion on the selection of testsoil formulation(s) based upon clinical use and physicalcharacteristics of clinically occurring soiling of the device.4.2 This guide provides the sample preparation techniquefor some test soils that simulate the soils found on medicaldevices as a result of clinical use.4.
26、3 An important aspect of the cleaning validation is deter-mining the appropriate test soil(s) used to contaminate thedevice.4.3.1 The manufacturer of the medical device or the repro-cessing equipment shall justify why the specific soil(s) waschosen and is appropriate for all cleaning markers/assays
27、to bemeasured.4.3.2 The determination and selection of soil(s) shall bebased upon the intended clinical use of the medical device. Themanufacturer needs to determine what the device will come incontact with (e.g., blood, mucus, cerebrospinal fluid, neuro-logical tissue, etc.) during clinical procedu
28、res how (e.g.,duration, complete immersion).4.3.3 The manufacturer should select a test soil(s) com-posed of a formulation that includes or accurately representsmaterials that the device would likely be subjected to duringclinical use and would create the worst-case challenge to thecleaning process4
29、.3.4 Ideally, the formulation of the test soil should becomposed of well-defined chemical/biochemical ingredientsand readily reproduced by any laboratory globally.5. Significance and Use5.1 This guide provides information on how to select thetest soil(s) that best simulates clinical use for devices.
30、 The testsoil(s) selected for the validation should be clinically relevantand simulate what the device/component will come intocontact with during the clinical procedure.5.2 This guide will help standardize the test soils used bymedical device manufacturers when validating the cleaningprocedures of
31、reusable medical devices and reprocessingequipment5.3 For devices that come into contact with blood, thesimulated test soils are blood-based soils, such as thosedescribed under 7.1.1 7.1.5.5.4 For devices that come into contact with mucus, thesimulated test soils are those described under 7.1.6.5.5
32、For devices that come in contact with soils of a sourceother than the patient (e.g., bone cement), the simulated testsoils should be similar to those described in 7.2. These can beused alone or in combination with 7.1.5.6 Acombination of test soils may be used (e.g., blood withmucus) to simulate cli
33、nical soiling. For example, flexibleendoscopes may come in contact with a different combinationof sources of soiling (e.g., gastrointestinal (GI) tract, vascula-ture for biopsies) during clinical use.5.7 Any simulated test soil(s) or formulations can be usedfor simulated use testing but shall be sci
34、entifically justified bythe medical device manufacturer.3Available from Association for the Advancement of Medical Instrumentation(AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http:/www.aami.org.4Available from International Organization for Standardization (ISO), ISOCentral Secr
35、etariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.5Available from U.S. Food and Drug Administration (FDA), 10903 NewHampshire Ave., Silver Spring, MD 20993, http:/www.fda.gov.F3208 1726. Soil Selection Criteria6.1 The test soils mentioned in this g
36、uide may be used tovalidate cleaning procedures as long as they can be scientifi-cally justified as simulating clinical soiling.6.2 Other formulations or modifications to the test soil(s)can be made but shall be scientifically justified by the manu-facturer as simulating clinical soiling.6.3 Mixture
37、s of different soils can be made depending onhow the device would be contaminated during a clinicalprocedure.6.3.1 When selecting a combination of soils, considerationshall be given to the clinical use of the device and the ratio ofthe soil(s) in the combined test soil that best simulatesclinically
38、occurring soiling reflecting worst-case conditions.6.4 Contamination by blood during clinical use is a commonoccurrence. There are multiple choices in the kind of blood soilselected for use.6.4.1 In clinical procedures in which the predominant soil isblood, and other agents (e.g., water for irrigati
39、on) that will notinterfere with the coagulation cascade, blood that can bechemically induced to coagulate is used. The coagulationprocess is induced before soiling the device.6.4.2 In clinical procedures in which blood is not thepredominant soil or other agents are present in sufficientvolume to pre
40、vent coagulation, defibrinated blood is used.NOTE 1If whole blood is extracted without defibrination or withoutadding an anticoagulant, it forms clots and clumps. As a result, it is noteasily used in test soil formulations.6.4.3 Types of Blood6.4.3.1 Defibrinated BloodWhole blood that has beentreate
41、d to denature fibrinogen without causing cell lysis.6.4.3.2 Anticoagulated Whole BloodAnticoagulatedwhole blood is selected in instances in which coagulation is tobe induced at the time of application to the device.(1) Citrated BloodBlood treated with sodium citrate toprevent coagulation. Coagulatio
42、n is induced with calciumchloride.(2) Heparinized BloodBlood rendered incoagulable byaddition of heparin. Coagulation is induced with protaminesulfate.7. Test Soils7.1 Test Soils Formulated to Simulate Patient-DerivedSoilsDuring clinical use, the key contaminants a medicaldevice comes in contact wit
43、h are from the patient. The soilsdescribed in this section are formulations that are intended tosimulate the characteristics of these soils as they represent achallenge to cleaning.7.1.1 Coagulating Blood-Based SoilsBlood is often theonly or predominant patient derived soil that medical devicescome
44、into contact with during clinical use. When this is thecase, the blood is likely to coagulate prior to the initiation ofcleaning steps, particularly in a worst-case scenario. Coagu-lated blood proteins are highly water insoluble and cansignificantly adhere to the medical device. The test soils in th
45、issection are intended to simulate the characteristics of coagu-lating blood.7.1.2 Two Component Blood Test Soil7.1.2.1 DescriptionA test soil correlating to coagulatedblood is based on a proteinaceous matrix containing fibrinogenand thrombin in two separated components. Coagulation of thesoil is in
46、duced after mixing these two components. GuideD7225 and Pfeifer (1)6describe this soil in further detail.7.1.2.2 ConstituentsThe blood test soil includes the fol-lowing:(1) Component AAlbumin, bovine, protease free: 400 mg;Hemoglobin, bovine, lyophilized: 400 mg;Fibrinogen, bovine, lyophilized: 60 m
47、g; andSolvent A, 5.0 mL 0.4 % NaCl solution (reagent gradeNaCl dissolved in sterile water).(2) Component BAlbumin, bovine, protease free: 400 mg;Hemoglobin, bovine, lyophilized: 400 mg;Thrombin, reagent grade from bovine plasma: 12.5 NIHunits; andSolvent B, 5.0 mL 0.4 % NaCl solution (reagent gradeN
48、aCl dissolved in sterile water) + 8.0 mmol/L CaCl2.7.1.2.3 Preparation(1) The soil is prepared by separately dissolving Compo-nents A and B in their respective solvents by shaking for1hatroom temperature.(2) Immediately before use, Components A and B aremixed together in a 1:1 ratio.7.1.2.4 MarkersS
49、uggested (not exclusive) cleaning mark-ers for residual analysis: protein, hemoglobin, and total organiccarbon (TOC).7.1.3 Blood Test Soil7.1.3.1 ConstituentsComponents of test soil include thefollowing:.(1) Whole sheep blood, citrated: 100 mL;(2) Bovine calf serum 50 mL;(3) Physiological saline solution (PHSS): 50 mL, 0.9 %NaCl; and(4) 0.01 mL of 2M CaCl2.7.1.3.2 PreparationThe soil is prepared by mixing all thewhole blood with blood serum and the saline solution togetherthoroughly. Then add the 0.01 mL of 2M CaCl2calciumchloride immediately before use to ac
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