ASTM D7225-13
(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 the Referenced Documents D5343, D4008, D4265, D4488, D2960, 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 and health practices and to determine the applicability of regulatory limitations prior to use.
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Designation: D7225 − 13
Standard Guide for
Blood Cleaning Efficiency of Detergents and Washer-
1
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 D2960Guide for Controlled Laundering Test Using Natu-
rally Soiled Fabrics and Household Appliances
1.1 This guide is based on a standardized test soil correlat-
D3050Guide for Measuring Soil Removal from Artificially
ing to coagulated blood suitable for screening tests and the
Soiled Fabrics (Not Suitable for Detergent Ranking)
evaluation of the cleaning efficiency of washer-disinfectors
4
2.2 AAMI Standards:
used for reprocessing of surgical instruments. This guide
ANSI/AAMI ST79Comprehensive guide to steam steriliza-
strictly deals with cleaning and does not describe any methods
tion and sterility assurance in health care facilities
that are related to disinfection. See the Referenced Documents
AAMI TIR 12Designing, testing, and labelling reusable
D5343, D4008, D4265, D4488, D2960, D3050, in Section 2
medical devices for reprocessing in health care facilities:
for additional information.
a guide for medical device manufacturers
1.2 The values stated in SI units are to be regarded as
ANSI/AAMI ST81Sterilization of medical devices – infor-
standard. No other units of measurement are included in this
mation to be provided by the manufacturer for the
standard.
processing of resterilizable medical devices
1.3 This standard does not purport to address all of the
AAMI TIR 30A compendium of processes, materials, test
safety concerns, if any, associated with its use. It is the
methods, and acceptance criteria for cleaning reusable
responsibility of the user of this standard to establish appro-
medical devices
priate safety and health practices and to determine the 5
2.3 ISO Standards
applicability of regulatory limitations prior to use.
ISO 15883–2Washer-disinfectors, part 2: requirements and
tests for washer-disinfectors employing thermal disinfec-
2. Referenced Documents
tion for surgical instruments, anaesthetic equipment,
2
2.1 ASTM Standards:
bowls, dishes, receivers, utensils, glassware, etc.
D5343Guide for Evaluating Cleaning Performance of Ce- ISO/TS 15883–5:2005Washer-disinfectors, part 5: test soils
ramic Tile Cleaners
and methods for demonstrating cleaning efficacy of
D4008Test Method for Measuring Anti-Soil Deposition washer-disinfectors
Properties of Laundry Detergents (Not Suitable for Deter-
3. Summary of Guide
gent Ranking)
D4265Guide for Evaluating Stain Removal Performance in
3.1 The standardized test soil is based on a proteinous
Home Laundering
matrix containing fibrinogen and thrombin in two separated
D4488Guide for Testing Cleaning Performance of Products
components. Coagulation and formation of fibrin fibers are
Intended for Use on Resilient Flooring and Washable
induced after mixing the two components.
3
Walls (Withdrawn 2009)
3.2 The suggested methods are based on the removal of
standardized test soil as a result of mechanical or chemical
action, or both, of the tested detergents or washer-disinfectors,
1
This guide is under the jurisdiction of ASTM Committee D12 on Soaps and
or both. The screening test provides qualitative results for
Other Detergents and is the direct responsibility of Subcommittee D12.16 on Hard
cleaning efficacy. After testing the practical situation in a
Surface Cleaning.
CurrenteditionapprovedJune1,2013.PublishedJuly2013.Originallyapproved
washer-disinfector, the end result is visually checked for
in 2006. Last previous edition approved in 2006 as D7225–06. DOI: 10.1520/
immediate evaluation. Minor residue is detected by using the
D7225-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
3 5
The last approved version of this historical standard is referenced on Available from International Organization for Standardization (ISO), 1, ch. de
www.astm.org. 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
1
---------------------- Page: 1 ----------------------
D7225 − 13
peroxidase reaction.The quantitative test provides quantitative instructions for use, the test provides a means to validate the
result
...
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: D7225 − 06 D7225 − 13
Standard Guide for
Blood Cleaning Efficiency of Detergents and Washer-
1
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. 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 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 D5343, D4008, D4265,
D4488, D2960, D3050, in Section 2 for additional information.
1.2 The values givenstated in SI units are to be considered the standard.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 and health practices and to determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D5343 Guide for Evaluating Cleaning Performance of Ceramic Tile Cleaners
D4008 Test Method for Measuring Anti-Soil Deposition Properties of Laundry Detergents (Not Suitable for Detergent Ranking)
D4265 Guide for Evaluating Stain Removal Performance in Home Laundering
D4488 Guide for Testing Cleaning Performance of Products Intended for Use on Resilient Flooring and Washable Walls
3
(Withdrawn 2009)
D2960 Guide for Controlled Laundering Test Using Naturally Soiled Fabrics and Household Appliances
D3050 Guide for Measuring Soil Removal from Artificially Soiled Fabrics (Not Suitable for Detergent Ranking)
4
2.2 AAMI Standards:
ANSI/AAMI ST35:2003ST79 Safe handling and biological decontamination of reusable medical devices Comprehensive guide
to steam sterilization and sterility assurance in health care facilities and in nonclinical settings
ANSI/AAMI ST46:2002AAMI TIR 12 Steam sterilization and sterility assurance Designing, testing, and labelling reusable
medical devices for reprocessing in health care facilitiesfacilities: a guide for medical device manufacturers
ANSI/AAMI ST81 Sterilization of medical devices – information to be provided by the manufacturer for the processing of
resterilizable medical devices
AAMI TIR 30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical
devices
5
2.3 ISO Standards
ISO 15883–2 Washer-disinfectors, part 2: requirements and tests for washer-disinfectors employing thermal disinfection for
surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO/TS 15883–5:2005 Washer-disinfectors, part 5: test soils and methods for demonstrating cleaning efficacy of washer-
disinfectors
1
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 Feb. 1, 2006June 1, 2013. Published March 2006July 2013. Originally approved in 2006. Last previous edition approved in 2006 as D7225 – 06.
DOI: 10.1520/D7225-06.10.1520/D7225-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
5
Available from International Organization for Standardization (ISO), 1, ch. de 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
1
---------------------- Page: 1 ----------------------
D7225 − 13
3. Summary of Guide
3.1 The standardized test soil is based on a proteinous matrix containing fibrinogen and thrombin in two separated components.
Coagulation and formation of fibrin fibers are induced after mixing the two components.
3.2 T
...
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