1、Designation: F3208 17F3208 18Standard 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 rev
2、ision, 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 describes methods for selecting test soils for cleaning validations based upon the chara
3、cteristics of the soil, thephysical characteristics of the device, and the clinical use of the device.1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusablemedical devices.1.3 Reusable medical devices such as endoscopes, arthrosco
4、pic shavers, surgical instruments, and suction tubes are exposed tobiological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization asapplicable.Adequate cleaning is the first step in a process intended to prevent contaminant transf
5、er to the next patient and medicalpractitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performanceof the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of theso
6、il or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference withdisinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints forcleaning established in the scientific literature.1.4 T
7、he test soils are designed to simulate the contaminants that medical devices are likely to come in contact with duringclinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in humansecretions, blood, tissue, and bone fragments/shavings
8、 as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes)during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material towhich the medical devices will be exposed.1.5 Exclusion:1.5.1 This guide does not include
9、methods to validate cleaning processes to remove residues from manufacturing1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfectionor sterilization validation requires separate testing that is independent of cleaning valida
10、tion studies.1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to comeinto contact.1.6 Test soil
11、formulations not described in this guide may be clinically relevant and may be more appropriate for simulated-usetesting depending upon the clinical use of the medical device. The burden is upon the medical device manufacturer to determineand justify scientifically the selection of test soil(s).1.7
12、The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish a
13、ppropriate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles
14、 for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.1 This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibil
15、ity of SubcommitteeF04.15 on Material Test Methods.Current edition approved Jan. 15, 2017Oct. 1, 2018. Published March 2017November 2018. Originally approved in 2017. Last previous edition approved in 2017 asF320817. DOI: 10.1520/F3208-17.10.1520/F3208-18.This document is not an ASTM standard and is
16、 intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the
17、current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12. Referenced Documents2.1 ASTM Standards:2D445 Test Method for Kinematic Viscosity of Trans
18、parent and Opaque Liquids (and Calculation of Dynamic Viscosity)D1193 Specification for Reagent WaterD3330/D3330M Test Method for Peel Adhesion of Pressure-Sensitive TapeD3359 Test Methods for Rating Adhesion by Tape TestD4212 Test Method for Viscosity by Dip-Type Viscosity CupsD4287 Test Method for
19、 High-Shear Viscosity Using a Cone/Plate ViscometerD7042 Test Method for Dynamic Viscosity and Density of Liquids by Stabinger Viscometer (and the Calculation of KinematicViscosity)D7225 Guide for Blood Cleaning Efficiency of Detergents and Washer-DisinfectorsD7867 Test Methods for Measurement of th
20、e Rotational Viscosity of Paints, Inks and Related Liquid Materials as a Functionof TemperatureF2809 Terminology Relating to Medical and Surgical Materials and Devices2.2 AAMI Standards:3TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities:
21、A guide formedical device manufacturersTIR30:2011 Acompendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices2.3 ISO Standard:4ISO/TS 15883-5 Washer-disinfectorsPart 5: Test soils and methods for demonstrating cleaning efficacy2.4 FDA Standard:5Re
22、processing Medical Devices in Health Care Settings Validation Methods and LabelingGuidance for Industry and Food andDrug Administration Staff3. Terminology3.1 DefinitionsUnless provided otherwise in the following definitions, terminology shall be in conformance with TerminologyF2809.3.1.1 cleaning,
23、nremoval of contamination from a medical device to the extent necessary for further processing or for intendeduse.3.1.2 cleaning marker, nthat which is being detected/measured to determine soil removal/retention.3.1.3 contamination, nprocedure of applying simulated test soil onto a medical device fo
24、r determination of process capability(that is, cleaning efficacy and extraction yields).3.1.4 test soil, nsingle substance or a mixture of substances that reflect the contaminants likely to be encountered during theuse of the device nin its intended clinical procedure.3.1.5 validation, ndocumented p
25、rocedure for obtaining, recording, and interpreting the results required to establish that aprocess will consistently yield results complying with predetermined specifications.3.1.5.1 DiscussionUnder U.S. FDA guidelines, validation of the instructions for cleaning is the responsibility of the medica
26、l device manufacturer.4. Summary of Guide4.1 This guide provides information on the selection of test soil formulation(s) based upon clinical use and physicalcharacteristics of clinically occurring soiling of the device.4.2 This guide provides the sample preparation technique for some test soils tha
27、t simulate the soils found on medical devicesas a result of clinical use.4.3 An important aspect of the cleaning validation is determining the appropriate test soil(s) used to contaminate the device.4.3.1 The manufacturer of the medical device or the reprocessing equipment shall justify why the spec
28、ific soil(s) was chosenand is appropriate for all cleaning markers/assays to be measured.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summa
29、ry page on the ASTM website.3 Available from Association for the Advancement of Medical Instrumentation (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http:/www.aami.org.4 Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin
30、 de Blandonnet 8, CP 401, 1214 Vernier, Geneva,Switzerland, http:/www.iso.org.5 Available from U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993, http:/www.fda.gov.F3208 1824.3.2 The determination and selection of soil(s) shall be based upon the intended clin
31、ical use of the medical device. Themanufacturer needs to determine what the device will come in contact with (e.g., blood, mucus, cerebrospinal fluid, neurologicaltissue, etc.) during clinical procedures how (e.g., duration, complete immersion).4.3.3 The manufacturer should select a test soil(s) com
32、posed of a formulation that includes or accurately represents materialsthat the device would likely be subjected to during clinical use and would create the worst-case challenge to the cleaning process4.3.4 Ideally, the formulation of the test soil should be composed of well-defined chemical/biochem
33、ical ingredients and readilyreproduced by any laboratory globally.5. Significance and Use5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s)selected for the validation should be clinically relevant and simulate what the
34、 device/component will come into contact with duringthe clinical procedure.5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning proceduresof reusable medical devices and reprocessing equipment5.3 For devices that come into contact with
35、 blood, the simulated test soils are blood-based soils, such as those described under7.1.1 7.1.57.1.1-7.1.2.5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.67.1.3.5.5 For devices that come in contact with soils of a source other than the pati
36、ent (e.g., bone cement), the simulated test soilsshould be similar to those described in 7.2. These can be used alone or in combination with 7.1.5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexibleendoscopes may come in contact with
37、 a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculaturefor biopsies) during clinical use.5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by themedical device manufacturer.6. Soil Selecti
38、on Criteria6.1 The test soils mentioned in this guide may be used to validate cleaning procedures as long as they can be scientificallyjustified 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 manufac
39、tureras simulating clinical soiling.6.3 Mixtures of different soils can be made depending on how the device would be contaminated during a clinical procedure.6.3.1 When selecting a combination of soils, consideration shall be given to the clinical use of the device and the ratio of thesoil(s) in the
40、 combined test soil that best simulates clinically occurring soiling reflecting worst-case conditions.6.4 Contamination by blood during clinical use is a common occurrence. There are multiple choices in the kind of blood soilselected for use.6.4.1 In clinical procedures in which the predominant soil
41、 is blood, and other agents (e.g., water for irrigation) that will notinterfere with the coagulation cascade, blood that can be chemically induced to coagulate is used. The coagulation process isinduced before soiling the device.6.4.2 In clinical procedures in which blood is not the predominant soil
42、 or other agents are present in sufficient volume to preventcoagulation, defibrinated blood is used.NOTE 1If whole blood is extracted without defibrination or without adding an anticoagulant, it forms clots and clumps. As a result, it is not easilyused in test soil formulations.6.4.3 Types of BloodB
43、lood:6.4.3.1 Defibrinated BloodWhole blood that has been treated to denature fibrinogen without causing cell lysis.6.4.3.2 Anticoagulated Whole BloodAnticoagulated whole blood is selected in instances in which coagulation is to be inducedat the time of application to the device.(1) Citrated BloodBlo
44、od treated with sodium citrate to prevent coagulation. Coagulation is induced with calcium chloride.(2) Heparinized BloodBlood rendered incoagulable by addition of heparin. Coagulation is induced with protamine sulfate.7. Test Soils7.1 Test Soils Formulated to Simulate Patient-Derived SoilsDuring cl
45、inical use, the key contaminants a medical device comesin contact with are from the patient. The soils described in this section are formulations that are intended to simulate thecharacteristics of these soils as they represent a challenge to cleaning.7.1.1 Coagulating Blood-Based SoilsBlood is ofte
46、n the only or predominant patient derived soil that medical devices comeinto contact with during clinical use. When this is the case, the blood is likely to coagulate prior to the initiation of cleaning steps,F3208 183particularly in a worst-case scenario. Coagulated blood proteins are highly water
47、insoluble and can significantly adhere to themedical device. The test soils in this section are intended to simulate the characteristics of coagulating blood.7.1.1 Two Component Blood Test Soil Coagulating Blood-Based Soils7.1.2.1 DescriptionA test soil correlating to coagulated blood is based on a
48、proteinaceous matrix containing fibrinogen andthrombin in two separated components. Coagulation of the soil is induced after mixing these two components. Guide D7225 andPfeifer (1)6 describe this soil in further detail.Blood is often the only or predominant patient derived soil that medical devices
49、comeinto contact with during clinical use. When this is the case, the blood is likely to coagulate prior to the initiation of cleaning steps,particularly in a worst-case scenario. Coagulated blood proteins are highly water insoluble and can significantly adhere to themedical device. The test soils in this section are intended to simulate the characteristics of coagulating blood.7.1.1.1 ConstituentsTwo Component Blood Test Soil The blood test soil includes the following:(1) ComponentDescription AA testAlbumin, bovine, protease free: 400 mg; soil correlatin
