ASTM F3208-20
(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 7.1.1-7.1.2.
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.
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.
1.6...
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
Designation: F3208 − 20
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 1.5.1 This guide does not include methods to validate
cleaning processes to remove residues from manufacturing
1.1 This guide describes methods for selecting test soils for
1.5.2 This guide does not describe the soil/inoculum used
cleaning validations based upon the characteristics of the soil,
for validation of disinfection or sterilization instructions. Dis-
thephysicalcharacteristicsofthedevice,andtheclinicaluseof
infection or sterilization validation requires separate testing
the device.
that is independent of cleaning validation studies.
1.2 This guide describes the preparation and use of some
1.5.3 Test soils described are not intended for use by health
test soils for the validation of cleaning instructions for reusable
care facilities to verify the effectiveness of their cleaning
medical devices.
process.
1.5.4 The test soil recipes are not intended to encompass
1.3 Reusable medical devices such as endoscopes, ar-
throscopic shavers, surgical instruments, and suction tubes are every biological residue with which a medical device is likely
to come into contact.
exposed to biological soils during clinical use. Preparation of
these devices for reuse requires cleaning and disinfection
1.6 Testsoilformulationsnotdescribedinthisguidemaybe
and/or sterilization as applicable.Adequate cleaning is the first
clinically relevant and may be more appropriate for simulated-
step in a process intended to prevent contaminant transfer to
use testing depending upon the clinical use of the medical
the next patient and medical practitioner. The soils, if inad-
device.The burden is upon the medical device manufacturer to
equately removed, can interfere with disinfection and steriliza-
determine and justify scientifically the selection of test soil(s).
tion processes, as well as performance of the device. Accep-
1.7 The values stated in SI units are to be regarded as the
tance criteria are based either on a visual assessment or
standard. No other units of measurement are included in this
quantitatively specified marker(s) endpoint(s) of the soil or
standard.
both (ISO/TS 15883-5, Section 1). Endpoints after cleaning
1.8 This standard does not purport to address all of the
should be based upon possible interference with disinfection/
safety concerns, if any, associated with its use. It is the
sterilization, risk to the patient or health care worker from the
responsibility of the user of this standard to establish appro-
contaminant during further handling, and endpoints for clean-
priate safety, health, and environmental practices and deter-
ing established in the scientific literature.
mine the applicability of regulatory limitations prior to use.
1.4 The test soils are designed to simulate the contaminants
1.9 This international standard was developed in accor-
that medical devices are likely to come in contact with during
dance with internationally recognized principles on standard-
clinical use. The test soils discussed in this guide are a mixture
ization established in the Decision on Principles for the
ofconstituentsthatsimulatewhatiscommonlyfoundinhuman
Development of International Standards, Guides and Recom-
secretions, blood, tissue, and bone fragments/shavings as well
mendations issued by the World Trade Organization Technical
as non-patient derived soil (e.g., bone cement, lubricants, and
Barriers to Trade (TBT) Committee.
dyes) during clinical procedures. The test soils also simulate
the physical parameters (e.g., viscosity, adhesion) of clinical
2. Referenced Documents
material to which the medical devices will be exposed.
2
2.1 ASTM Standards:
1.5 Exclusion:
D445 Test Method for Kinematic Viscosity of Transparent
and Opaque Liquids (and Calculation of Dynamic Viscos-
ity)
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved July 15, 2020. Published August 2020. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2017. Last previ
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it 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 current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3208 − 19 F3208 − 20
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
1.1 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
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Nov. 15, 2019July 15, 2020. Published January 2020August 2020. Originally approved in 2017. Last previous edition approved in 20182019
as F3208 – 18.F3208 – 19. DOI: 10.1520/F3208-19.10.1520/F3208-20.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3208 − 20
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.
1.6 Test soil formulations not described in this guide may be clinically relevant and may be more appropriate for simulated-use
testing depending upon the clinical use of the medical device. The burden is upon the medical device manufacturer to determine
and justify scientifically the selection of test soil(s).
1.7 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 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.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.