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ASTM F3208-17

(Guide)

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 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 device/component will come into contact with during the clinical procedure.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1 – 7.1.5.  
5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.6.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should 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, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for 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 the medical device manufacturer.
SCOPE
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical 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 reusable medical devices.  
1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings 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 to which the medical devices will be exposed.  
1.5 Exclusion:  
1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing  
1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation 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 come into contact.  
1...

General Information

Status
Historical
Publication Date
14-Jan-2017
ICS
11.040.01 - Medical equipment in general
11.080.01 - Sterilization and disinfection in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaced By
ASTM F3208-18 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
01-Oct-2018
Referred By
ASTM F3321-19 - Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
15-Jan-2017
Referred By
ASTM F3293-18 - Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
15-Jan-2017
Referred By
ASTM F3438-21 - Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
15-Jan-2017
Referred By
ASTM F3276-22 - Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
Effective Date
15-Jan-2017
Referred By
ASTM D8179-18 - Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
Effective Date
15-Jan-2017
Referred By
ASTM F3275-22 - Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
Effective Date
15-Jan-2017

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ASTM F3208-17 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical DevicesASTM F3208-17 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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ASTM F3208-17 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3208 − 17
Standard Guide for
Selecting Test Soils for Validation of Cleaning Methods for
1
Reusable Medical Devices
This standard is issued under the fixed designation F3208; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5.2 This guide does not describe the soil/inoculum used
for validation of disinfection or sterilization instructions. Dis-
1.1 This guide describes methods for selecting test soils for
infection or sterilization validation requires separate testing
cleaning validations based upon the characteristics of the soil,
that is independent of cleaning validation studies.
thephysicalcharacteristicsofthedevice,andtheclinicaluseof
1.5.3 Test soils described are not intended for use by health
the device.
care facilities to verify the effectiveness of their cleaning
1.2 This guide describes the preparation and use of some
process.
test soils for the validation of cleaning instructions for reusable
1.5.4 The test soil recipes are not intended to encompass
medical devices.
every biological residue with which a medical device is likely
to come into contact.
1.3 Reusable medical devices such as endoscopes, ar-
throscopic shavers, surgical instruments, and suction tubes are
1.6 Testsoilformulationsnotdescribedinthisguidemaybe
exposed to biological soils during clinical use. Preparation of
clinically relevant and may be more appropriate for simulated-
these devices for reuse requires cleaning and disinfection
use testing depending upon the clinical use of the medical
and/or sterilization as applicable.Adequate cleaning is the first
device.The burden is upon the medical device manufacturer to
step in a process intended to prevent contaminant transfer to
determine and justify scientifically the selection of test soil(s).
the next patient and medical practitioner. The soils, if inad-
1.7 The values stated in SI units are to be regarded as the
equately removed, can interfere with disinfection and steriliza-
standard. No other units of measurement are included in this
tion processes, as well as performance of the device. Accep-
standard.
tance criteria are based either on a visual assessment or
1.8 This standard does not purport to address all of the
quantitatively specified marker(s) endpoint(s) of the soil or
safety concerns, if any, associated with its use. It is the
both (ISO/TS 15883-5, Section 1). Endpoints after cleaning
responsibility of the user of this standard to establish appro-
should be based upon possible interference with disinfection/
priate safety and health practices and determine the applica-
sterilization, risk to the patient or health care worker from the
bility of regulatory limitations prior to use.
contaminant during further handling, and endpoints for clean-
ing established in the scientific literature.
2. Referenced Documents
1.4 The test soils are designed to simulate the contaminants
2
2.1 ASTM Standards:
that medical devices are likely to come in contact with during
D445 Test Method for Kinematic Viscosity of Transparent
clinical use. The test soils discussed in this guide are a mixture
and Opaque Liquids (and Calculation of Dynamic Viscos-
ofconstituentsthatsimulatewhatiscommonlyfoundinhuman
ity)
secretions, blood, tissue, and bone fragments/shavings as well
D1193 Specification for Reagent Water
as non-patient derived soil (e.g., bone cement, lubricants, and
D3330/D3330M TestMethodforPeelAdhesionofPressure-
dyes) during clinical procedures. The test soils also simulate
Sensitive Tape
the physical parameters (e.g., viscosity, adhesion) of clinical
D3359 Test Methods for Measuring Adhesion by Tape Test
material to which the medical devices will be exposed.
D4212 Test Method for Viscosity by Dip-Type Viscosity
1.5 Exclusion:
Cups
1.5.1 This guide does not include methods to validate
D4287 Test Method for High-Shear Viscosity Using a Cone/
cleaning processes to remove residues from manufacturing
Plate Viscometer
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
2
and Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.15 on Material Test Methods. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Jan. 15, 2017. Published March 2017. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3208-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
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1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.  
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1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 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 device/component will come into contact with during the clinical procedure.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1-7.1.2.  
5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should 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, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use.  
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1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical 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 reusable medical devices.  
1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings 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 to which the medical devices will be exposed.  
1.5 Exclusion:  
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1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies.  
1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.  
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5.2 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
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SIGNIFICANCE AND USE
5.1 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 device/component will come into contact with during the clinical procedure.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
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Standard Guide for Taking Property and Behavior Measurements on Weathered Fractions of Oil

SIGNIFICANCE AND USE
5.1 A standard procedure is necessary to establish property changes for spilled oils or petroleum products at different oil weathering stages.  
5.2 This procedure employs standardized equipment, and test procedures.  
5.3 This procedure should be performed at the stages of weathering corresponding to the spill conditions of interest.
SCOPE
1.1 This guide summarizes methods to fractionate oil by evaporative weathering and then measure the properties and behavior of the weathered oil. The results of this guide can provide oil behavior data for input into oil spill models and response method selection.  
1.2 This guide covers general procedures for oil weathering and behavior and does not cover all possible procedures which may be applicable to this topic.  
1.3 The results obtained using this guide are intended to provide baseline data for the behavior of oil and petroleum products when spilled and input to oil spill models.  
1.4 The results obtained using this guide can be used directly to predict certain facets of oil spill behavior or as input to oil spill models.  
1.5 The accuracy of the guide depends very much on the representative nature of the oil sample used. Certain oils can have different properties depending on their chemical contents at the moment a sample is taken.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
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  • Guide
    4 pages
    English language
    sale 15% off