ASTM D7225-13(2019)e1
(Guide)Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors
SIGNIFICANCE AND USE
4.1 Significance—Dried blood represents a significant challenge to cleaning surgical instruments. The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble component of blood is fibrin built up during coagulation. These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood residue after reprocessing represent a significant threat for infection to healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean surgical instruments. To function properly, these machines must be performing at targeted mechanical efficiency and deliver the correct chemical cleaning agents at the correct temperature, at the correct dosage for the correct period of time. Manufacturers of automated washers and manufacturers of cleaning detergent need to evaluate the performance of their products utilizing a surrogate for surgical instruments soiled with blood. The results of the performance testing will be used to improve product design and for validation of the performance of their product for various regulatory requirements.
4.2 Use—The regular, periodic use of the blood soil test is a systemic challenge to the functioning of an automated washer. To properly challenge the cleaning device, the test must be analogous to the dried blood soil, to the stainless steel substrate, and to the physical barriers presented by surgical instruments. These physical barriers include the box lock, or pivot joint of a hinged instrument, the serrated tips, and crevices of surgical instruments. On the test coupon, the components of blood are similar to the state of dried blood on instruments. By utiliz...
SCOPE
1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.
1.2 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.
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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.
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Designation: D7225 − 13 (Reapproved 2019)
Standard Guide for
Blood Cleaning Efficiency of Detergents and Washer-
Disinfectors
This standard is issued under the fixed designation D7225; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—Referenced Documents were updated editorially in May 2019.
1. Scope D4265Guide for Evaluating Stain Removal Performance in
Home Laundering
1.1 This guide is based on a standardized test soil correlat-
D2960Guide for Controlled Laundering Test Using Natu-
ing to coagulated blood suitable for screening tests and the
rally Soiled Fabrics and Household Appliances (With-
evaluation of the cleaning efficiency of washer-disinfectors
drawn 2013)
used for reprocessing of surgical instruments. This guide
D3050Guide for Measuring Soil Removal from Artificially
strictly deals with cleaning and does not describe any methods
Soiled Fabrics (Not Suitable for Detergent Ranking)
that are related to disinfection. See Referenced Documents
D5343, D4008, D4265, D2960, and D3050 in Section 2 for 2.2 AAMI Standards:
ANSI/AAMI ST79Comprehensive guide to steam steriliza-
additional information.
tion and sterility assurance in health care facilities
1.2 The values stated in SI units are to be regarded as
AAMI TIR 12Designing, testing, and labelling reusable
standard. No other units of measurement are included in this
medical devices for reprocessing in health care facilities:
standard.
a guide for medical device manufacturers
1.3 This standard does not purport to address all of the
ANSI/AAMI/ISO 17664Processing of health care prod-
safety concerns, if any, associated with its use. It is the
ucts–Information to be provided by the medical device
responsibility of the user of this standard to establish appro-
manufacturer for the processing of medical devices
priate safety, health, and environmental practices and deter-
AAMI TIR 30A compendium of processes, materials, test
mine the applicability of regulatory limitations prior to use.
methods, and acceptance criteria for cleaning reusable
1.4 This international standard was developed in accor-
medical devices
dance with internationally recognized principles on standard-
2.3 ISO Standards
ization established in the Decision on Principles for the
ISO 15883–2Washer-disinfectors, part 2: requirements and
Development of International Standards, Guides and Recom-
tests for washer-disinfectors employing thermal disinfec-
mendations issued by the World Trade Organization Technical
tion for surgical instruments, anaesthetic equipment,
Barriers to Trade (TBT) Committee.
bowls, dishes, receivers, utensils, glassware, etc.
ISO/TS 15883–5Washer-disinfectors, part 5: test soils and
2. Referenced Documents
methods for demonstrating cleaning efficacy of washer-
2.1 ASTM Standards:
disinfectors
D5343Guide for Evaluating Cleaning Performance of Ce-
ramic Tile Cleaners
3. Summary of Guide
D4008GuideforMeasuringAnti-SoilDepositionProperties
3.1 The standardized test soil is based on a proteinous
of Laundry Detergents
matrix containing fibrinogen and thrombin in two separated
components. Coagulation and formation of fibrin fibers are
1 induced after mixing the two components.
This guide is under the jurisdiction of ASTM Committee D12 on Soaps and
Other Detergents and is the direct responsibility of Subcommittee D12.16 on Hard
Surface Cleaning.
Current edition approved May 1, 2019. Published May 2019. Originally
approved in 2006. Last previous edition approved in 2013 as D7225–13. DOI: The last approved version of this historical standard is referenced on
10.1520/D7225-13R19E01. www.astm.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036.
Standards volume information, refer to the standard’s Document Summary page on Available from International Organization for Standardization (ISO), 1, ch. de
the ASTM website. la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D7225 − 13 (2019)
3.2 The suggested methods are based on the removal of Failure to remove any soil indicates either a catastrophic
standardized test soil as a result of mechanical or chemical mechanicalfailure,orinappropriatesettingsfortheinitialrinse
action, or both, of the tested detergents or washer-disinfectors, stage. As a standardized challenge, the test provides a repro-
or both. The screening test provides qualitative results for ducible means for the washer manufacturer and the detergent
cleaning efficacy. After testing the practical situation in a manufacturer to compare new designs and formulations to
washer-disinfector, the end result is visually checked for those existing within their own product line as well as those of
immediate evaluation. Minor residue is detected by using the others in the market. For the purpose of submitting their
peroxidase reaction.The quantitative test provides quantitative instructions for use, the test provides a means to validate the
results for cleaning efficacy by providing measuring the re- performance of their product with a device that is a surrogate
moval of a known amount of protein. After placement of the for the devices their products will be used to clean in the
test coupon within a washer or in a beaker of water, the end practical setting. This validation testing can be used as part of
result is measured gravimetrically or by spectrophotometer any necessary documentation for regulatory filings and re-
detection of protein residue, or both. cords.
5. Reagents and Materials
4. Significance and Use
5.1 Standardized Test Soil
4.1 Significance—Dried blood represents a significant chal-
5.1.1 Composition:
lenge to cleaning surgical instruments. The water-soluble
5.1.1.1 Component A:
components of blood are easily rendered insoluble when
400-mg albumin, bovine, protease free;
exposed to heat, chemical solutions, or time at room tempera-
400-mg hemoglobin, bovine, lyophilized; and
ture.The water insoluble component of blood is fibrin built up
60-mg fibrinogen, bovine, lyophilized.
during coagulation. These proteins bind quite readily to the
5.1.1.2 Component B:
surfaces of surgical instruments making them difficult to
400-mg albumin, bovine, protease free;
remove even with the aid of chemical cleaning agents. Instru-
400-mg hemoglobin, bovine, lyophilized; and
ments contaminated with blood residue after reprocessing
12.5-NIH units thrombin, reagent grade from bovine
representasignificantthreatforinfectiontohealthcareworkers
plasma.
and patients. Healthcare facilities typically employ the use of
5.1.1.3 Solvent A—5.0-mL 0.4% NaCl solution (Reagent
automated instrument washers. These devices combine me-
grade NaCl dissolved in sterile water).
chanicalactionalongwithchemicalcleaningagentsinastaged
5.1.1.4 Solvent B—5.0-mL 0.4% NaCl solution + 8.0-
cleaning cycle designed to thoroughly clean surgical instru-
mmol/L CaCl . (Reagent grade NaCl dissolved in sterile
ments. To function properly, these machines must be perform- 2
water).
ing at targeted mechanical efficiency and deliver the correct
chemical cleaning agents at the correct temperature, at the
5.2 Preparation—Components A and B are dissolved in
correct dosage for the correct period of time. Manufacturers of
their corresponding Solvents A and B by shaking for1hat
automated washers and manufacturers of cleaning detergent
room temperature (from 20 to 37°C ) in two sealed 10-mL
need to evaluate the performance of their products utilizing a
glass vials. Shak
...
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