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ASTM F3293-18

(Guide)

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

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

SIGNIFICANCE AND USE
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 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.  
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.  
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.  
1.4 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.

General Information

Status
Published
Publication Date
30-Apr-2018
ICS
11.020.01 - Quality and environmental management in health care
11.040.01 - Medical equipment in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Refers
ASTM F3208-20 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
15-Jul-2020
Refers
ASTM D7225-13(2019)e1 - Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
Effective Date
01-May-2019
Refers
ASTM F3208-18 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
01-Oct-2018
Refers
ASTM F3208-19 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
Effective Date
15-Nov-2019
Refers
ASTM F3208-17 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
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
01-May-2018
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
01-May-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
01-May-2018

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ASTM F3293-18 - Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical DevicesASTM F3293-18 - Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
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ASTM F3293-18 - Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
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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: F3293 − 18
Standard Guide for
Application of Test Soils for the Validation of Cleaning
1
Methods for Reusable Medical Devices
This standard is issued under the fixed designation F3293; 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.
3
1. Scope 2.2 AAMI Standards:
AAMI TIR30 A compendium of processes, materials, test
1.1 This guide provides methods and considerations for
methods, and acceptance criteria for cleaning reusable
simulated soiling of reusable medical devices for the purpose
medical devices
of validating cleaning instructions. Techniques for application
AAMIST79 Comprehensiveguidetosteamsterilizationand
of soil, as well as incorporation of soil by various means (e.g.,
sterility assurance in health care facilities
actuation of devices) will be described in order to assure
4
2.3 ISO Standard:
worst-case contamination of the surface geometry of medical
ISO 10993-12 Biological evaluation of medical devices—
devices.
Part 12: Sample preparation and reference materials
1.2 Units—The values stated in SI units are to be regarded
2.4 Other References:
as standard. No other units of measurement are included in this
ANSI/ASHRAE/ASHE Standard 170-2013 Ventilation of
5
standard.
health care facilities; Atlanta: ASHRAE, 2013b
1.3 This standard does not purport to address all of the
GuidanceforIndustryandFDAStaff, Processing/Reprocess-
safety concerns, if any, associated with its use. It is the ing Medical Devices in Health Care Settings: Validation
6
responsibility of the user of this standard to establish appro-
Methods and Labeling, 2015
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accor- 3.1 For definitions of terms in this Guide relating to the use
dance with internationally recognized principles on standard-
of test soils for cleaning validation, refer to the Terminology
ization established in the Decision on Principles for the Section of ASTM F3208.
Development of International Standards, Guides and Recom-
4. Summary of Practice
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
4.1 The standard provides details on the application (inocu-
lation) of the test soil for testing, evaluation, and validation of
2. Referenced Documents
cleaning procedures. It includes:
2
2.1 ASTM Standards: 4.2 The methods for soiling a medical device.
D1193 Specification for Reagent Water
4.3 The selection of the appropriate method(s) for soiling a
D7225 Guide for Blood Cleaning Efficiency of Detergents
device based upon clinical use of the device.
and Washer-Disinfectors
4.4 Identification of area(s) of the device to soil based upon
F2809 Terminology Relating to Medical and Surgical Mate-
worst-case clinical use and device design.
rials and Devices
F3208 Guide for Selecting Test Soils for Validation of
4.5 Establishingthedwelltimeforthesoileddevice,priorto
Cleaning Methods for Reusable Medical Devices
beginning cleaning procedures, based upon worst-case clinical
conditions/practice.
1 3
This practice/guide is under the jurisdiction of ASTM Committee F04 on Available from Association for the Advancement of Medical Instrumentation
Medical and Surgical Materials and Devices and is the direct responsibility of (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
Subcommittee F04.15 on Material Test Methods. www.aami.org.
4
Current edition approved May 1, 2018. Published May 2018. DOI: 10.1520/ Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
F3293-18. 4th Floor, New York, NY 10036, http://www.ansi.org.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or https://www.ashrae.org/resources-publications/bookstore/health-care-facilities-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM resources
6
Standards volume information, refer to the standard’s Document Summary page on www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guid-
the ASTM website. ancedocuments/ucm253010.pdf
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3293 − 18
4.6 Identification of other worst-case clinical use conditions 8. Determining Clinically Relevant Worst-Case Dry
...

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5.1 This practice is recommended for use primarily for non-occupational exposure monitoring in domiciles, public access buildings, and offices.  
5.2 The methods described in this practice have been successfully applied to measurement of pesticides and PCBs in outdoor air and for personal respiratory exposure monitoring.  
5.3 A broad spectrum of pesticides are commonly used in and around the house and for insect control in public and commercial buildings. Other semivolatile organic chemicals, such as PCBs, are also often present in indoor air, particularly in large office buildings. This practice promotes needed precision and bias in the determination of many of these airborne chemicals.
SCOPE
1.1 This practice covers the sampling of air for a variety of common pesticides and polychlorinated biphenyls (PCBs) and provides guidance on the selection of appropriate analytical measurement methods. Other compounds such as polychlorinated dibenzodioxins/furans, polybrominated biphenyls, polybrominated diphenyl ethers, polycyclic aromatic hydrocarbons, and polychlorinated naphthalenes may be efficiently collected from air by this practice, but guidance on their analytical determination is not covered by this practice.  
1.2 The sampling and analysis of PCBs in air can be more complicated than sampling PCBs in solid media (for example, soils, building materials) or liquids (for example, transformer fluids). PCBs in solid or liquid material are typically analyzed using Aroclor2 distillation groups in chromatograms. In contrast, recent research has shown that analysis of PCBs in air samples by GC-ECD has also been found to exhibit potential uncertainties due to changes in the PCB patterns, differences in responses in distillation groups, peak co-elutions and differences in response factors within a homolog group (1, 2).3 As such it is recommended that PCBs in air not be quantified using AroclorTM distillation groups. In addition, it is recommended that analysis of PCBs in air be done using GC-MS rather than GC-ECD. Any mention, to outdated practices for “Aroclor” and GC-ECD analysis of PCBs herein are retained solely for historical perspective.  
1.3 A complete listing of pesticides and other semivolatile organic chemicals for which this practice has been tested is shown in Table 1.  
1.4 This practice is based on the collection of chemicals from air onto polyurethane foam (PUF) or a combination of PUF and granular sorbent (for example, diphenyl oxide, styrene-divinylbenzene), or a granular sorbent alone.  
1.5 This practice is applicable to multicomponent atmospheres, 0.001 μg/m3 to 50 μg/m3 concentrations, and 4 h to 24 h sampling periods. The limit of detection will depend on the nature of the analyte and the length of the sampling period.  
1.6 The analytical method(s) recommended will depend on the specific chemical(s) sought, the concentration level, and the degree of specificity required.  
1.7 The values stated in SI units are to be regarded as 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. For specific hazards statements, see 10.24 and A1.1.  
1.9 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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