ASTM D7225-06
(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
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.
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 both the dried blood soil 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 mimic the state of dried blood on instruments. By mounting the soiled coupon in a plastic holder the physical barriers represented by cracks and crevices of instruments (for example, box locks) are mimicked. Users are provided with an interpretation guide that aids them in interpreting results that are less than optimal. For instance, failure to remove the fibrin layer of blood soil (which is water insoluble) indicates a problem with the chemical cleaning agent(...
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 the Referenced Documents in Section 2 for additional information.
1.2 The values given in SI units are to be considered the 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 and health practices and to determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: D7225 − 06
StandardGuide 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.
1. Scope D3050Guide for Measuring Soil Removal fromArtificially
Soiled Fabrics (Not Suitable for Detergent Ranking)
1.1 This guide is based on a standardized test soil correlat-
2.2 AAMI Standards:
ing to coagulated blood suitable for screening tests and the
ANSI/AAMI ST35:2003Safe handling and biological de-
evaluation of the cleaning efficiency of washer-disinfectors
contamination of reusable medical devices in health care
used for reprocessing of surgical instruments. This guide
facilities and in nonclinical settings
strictly deals with cleaning and does not describe any methods
ANSI/AAMI ST46:2002Steam sterilization and sterility
that are related to disinfection. See the Referenced
assurance in health care facilities
DocumentsD5343, D4008, D4265, D4488, D2960, D3050,in
Section 2 for additional information.
3. Summary of Guide
1.2 The values given in SI units are to be considered the
3.1 The standardized test soil is based on a proteinous
standard.
matrix containing fibrinogen and thrombin in two separated
components. Coagulation and formation of fibrin fibers are
1.3 This standard does not purport to address all of the
induced after mixing the two components.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.2 The suggested methods are based on the removal of
priate safety and health practices and to determine the
standardized test soil as a result of mechanical or chemical
applicability of regulatory limitations prior to use.
action, or both, of the tested detergents or washer-disinfectors,
or both. The screening test provides qualitative results for
2. Referenced Documents
cleaning efficacy. After testing the practical situation in a
2.1 ASTM Standards:
washer-disinfector, the end result is visually checked for
D5343Guide for Evaluating Cleaning Performance of Ce- immediate evaluation. Minor residue is detected by using the
ramic Tile Cleaners
peroxidase reaction.
D4008Test Method for Measuring Anti-Soil Deposition
4. Significance and Use
Properties of Laundry Detergents (Not Suitable for Deter-
4.1 Significance—Dried blood represents a significant chal-
gent Ranking)
lenge to cleaning surgical instruments. The water-soluble
D4265Guide for Evaluating Stain Removal Performance in
components of blood are easily rendered insoluble when
Home Laundering
exposed to heat, chemical solutions, or time at room tempera-
D4488Guide for Testing Cleaning Performance of Products
Intended for Use on Resilient Flooring and Washable ture.The water insoluble component of blood is fibrin built up
during coagulation. These proteins bind quite readily to the
Walls (Withdrawn 2009)
D2960Guide for Controlled Laundering Test Using Natu- surfaces of surgical instruments making them difficult to
remove even with the aid of chemical cleaning agents. Instru-
rally Soiled Fabrics and Household Appliances
ments contaminated with blood residue after reprocessing
representasignificantthreatforinfectiontohealthcareworkers
This guide is under the jurisdiction of ASTM Committee D12 on Soaps and
and patients. Healthcare facilities typically employ the use of
Other Detergents and is the direct responsibility of Subcommittee D12.16 on Hard
automated instrument washers. These devices combine me-
Surface Cleaning.
chanicalactionalongwithchemicalcleaningagentsinastaged
Current edition approved Feb. 1, 2006. Published March 2006. DOI: 10.1520/
cleaning cycle designed to thoroughly clean surgical instru-
D7225-06.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ments. To function properly, these machines must be perform-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ing at targeted mechanical efficiency and deliver the correct
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
The last approved version of this historical standard is referenced on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.astm.org. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D7225 − 06
chemical cleaning agents at the correct temperature, at the 6.1.1.2 Fifty microlitres of the dissolved ComponentAand
correct dosage for the correct period of time. 50µLofthedissolvedComponentBaredosedontothesurface
of the coupons, mixed, and spread to cover approximately 4
4.2 Use—Theregular,periodicuseofthebloodsoiltestisa
cm . Both components are dosed on the same spot of the same
systemic challenge to the functioning of an automated washer.
side of the plate, mixed (with pipette) and spread onto the
To properly challenge the cleaning device, the test must be
surface.
analogous to both the dried blood soil and to the physical
6.1.1.3 The test coupons are then dried at room temperature
barriers presented by surgical instruments. These physical
(68°F - 77°F) and 40 to 60% humidity for 24 h (convection
barriers include the box lock, or pivot joint of a hinged
maybeusedtospeedthedryingprocess).Couponsneedstobe
instrument, the serrated tips, and crevices of surgical instru-
stored out of reach of any chemicals or fumes (for example,
ments.Onthetestcoupon,thecomponentsofbloodmimicthe
disinfectants, detergents, or solvents).
state of dried blood on instruments. By mounting the soiled
coupon in a plastic holder the physical barriers represented by
7. Procedure
cracksandcrevicesofinstruments(forexample,boxlocks)are
7.1 Peroxidase Reaction for the Detection of Residue
mimicked.Usersareprovidedwithaninterpretationguidethat
7.1.1 Test Solution:
aids them in interpreting results that are less than optimal. For
7.1.1.1 Solution 1—0.1% tetramethylbenzidine (TMB) in
instanc
...
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