1、Designation: D 7225 06Standard Guide forBlood Cleaning Efficiency of Detergents and Washer-Disinfectors1This standard is issued under the fixed designation D 7225; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last re
2、vision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is based on a standardized test soil correlat-ing to coagulated blood suitable for screening tests and theevaluat
3、ion of the cleaning efficiency of washer-disinfectorsused for reprocessing of surgical instruments. This guidestrictly deals with cleaning and does not describe any methodsthat are related to disinfection. See the Referenced Documentsin Section 2 for additional information.1.2 The values given in SI
4、 units are to be considered thestandard.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory
5、 limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 5343 Guide for Evaluating Cleaning Performance ofCeramic Tile CleanersD 4008 Test Method for Measuring Anti-Soil DepositionProperties of Laundry Detergents (Not Suitable for Deter-gent Ranking)D 4265 Guide for Evaluating Stain Re
6、moval Performancein Home LaunderingD 4488 Guide for Testing Cleaning Performance of Prod-ucts Intended for Use on Resilient Flooring and WashableWallsD 2960 Guide for Controlled Laundering Test Using Natu-rally Soiled Fabrics and Household AppliancesD 3050 Guide for Measuring Soil Removal fromArtifi
7、ciallySoiled Fabrics (Not Suitable for Detergent Ranking)2.2 AAMI Standards:3ANSI/AAMI ST35:2003 Safe handling and biological de-contamination of reusable medical devices in health carefacilities and in nonclinical settingsANSI/AAMI ST46:2002 Steam sterilization and sterilityassurance in health care
8、 facilities3. Summary of Guide3.1 The standardized test soil is based on a proteinousmatrix containing fibrinogen and thrombin in two separatedcomponents. Coagulation and formation of fibrin fibers areinduced after mixing the two components.3.2 The suggested methods are based on the removal ofstanda
9、rdized test soil as a result of mechanical or chemicalaction, or both, of the tested detergents or washer-disinfectors,or both. The screening test provides qualitative results forcleaning efficacy. After testing the practical situation in awasher-disinfector, the end result is visually checked forim
10、mediate evaluation. Minor residue is detected by using theperoxidase reaction.4. Significance and Use4.1 SignificanceDried blood represents a significant chal-lenge to cleaning surgical instruments. The water-solublecomponents of blood are easily rendered insoluble whenexposed to heat, chemical solu
11、tions, or time at room tempera-ture. The water insoluble component of blood is fibrin built upduring coagulation. These proteins bind quite readily to thesurfaces of surgical instruments making them difficult toremove even with the aid of chemical cleaning agents. Instru-ments contaminated with bloo
12、d residue after reprocessingrepresent a significant threat for infection to healthcare workersand patients. Healthcare facilities typically employ the use ofautomated instrument washers. These devices combine me-chanical action along with chemical cleaning agents in a stagedcleaning cycle designed t
13、o thoroughly clean surgical instru-ments. To function properly, these machines must be perform-ing at targeted mechanical efficiency and deliver the correct1This guide is under the jurisdiction of ASTM Committee D12 on Soaps andOther Detergents and is the direct responsibility of Subcommittee D12.16
14、 on HardSurface Cleaning.Current edition approved Feb. 1, 2006. Published March 2006.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary
15、page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.chemical cleaning agents at the correct temperature, a
16、t thecorrect dosage for the correct period of time.4.2 UseThe regular, periodic use of the blood soil test isa systemic challenge to the functioning of an automatedwasher. To properly challenge the cleaning device, the testmust be analogous to both the dried blood soil and to thephysical barriers pr
17、esented by surgical instruments. Thesephysical barriers include the box lock, or pivot joint of a hingedinstrument, the serrated tips, and crevices of surgical instru-ments. On the test coupon, the components of blood mimic thestate of dried blood on instruments. By mounting the soiledcoupon in a pl
18、astic holder the physical barriers represented bycracks and crevices of instruments (for example, box locks) aremimicked. Users are provided with an interpretation guide thataids them in interpreting results that are less than optimal. Forinstance, failure to remove the fibrin layer of blood soil (w
19、hichis water insoluble) indicates a problem with the chemicalcleaning agent(s). Failure to evenly remove a hemoglobin soilindicates a mechanical failure. Failure to remove any soilindicates either a catastrophic mechanical failure, or inappro-priate settings for the initial rinse stage.5. Reagents a
20、nd Materials5.1 Standardized Test Soil5.1.1 Composition:5.1.1.1 Component A:400-mg albumine, bovine, protease free;400-mg hemoglobin, bovine, lyophilized; and60-mg fibrinogen, bovine, lyophilized.5.1.1.2 Component B:400-mg albumine, bovine, protease free;400-mg hemoglobin, bovine, lyophilized; and12
21、.5-NIH units thrombin, reagent grade from bovineplasma.5.1.1.3 Solvent A5.0-mL 0.4 % NaCl solution (Reagentgrade NaCl dissolved in sterile water).5.1.1.4 Solvent B5.0-mL 0.4 % NaCl solution + 8.0-mmol/L CaCl2. (Reagent grade NaCl dissolved in sterilewater).5.2 PreparationComponents A and B are disso
22、lved intheir corresponding Solvents A and B by shaking for1hatroom temperature (from 20C - 37C ) in two sealed 10-mLglass vials. Shaking by hand is acceptable and the mosteasy/practical solution and is tested to give reliable results. Alaboratory quality shaker could be used for a more reproduciblep
23、rocess.6. Sampling, Test Specimens, and Test Units6.1 Preparation of Test Coupons6.1.1 Coupons for Screening Test6.1.1.1 Stainless steel plates (70 3 20 3 1 mm, material:1.4301) are used for the screening test to evaluate the chemicalefficiency of detergents. The steel plates must be precleanedand f
24、ree of any residue. They should be marked with awaterproof marker. A blind control of the finished test shouldalways be conducted: Immersion test of a test object indemineralized water at room temperature (58F-77F).6.1.1.2 Fifty microlitres of the dissolved Component A and50 L of the dissolved Compo
25、nent B are dosed onto the surfaceof the coupons, mixed, and spread to cover approximately 4cm2. Both components are dosed on the same spot of the sameside of the plate, mixed (with pipette) and spread onto thesurface.6.1.1.3 The test coupons are then dried at room temperature(68F - 77F) and 40 to 60
26、 % humidity for 24 h (convectionmay be used to speed the drying process). Coupons needs to bestored out of reach of any chemicals or fumes (for example,disinfectants, detergents, or solvents).7. Procedure7.1 Peroxidase Reaction for the Detection of Residue7.1.1 Test Solution:7.1.1.1 Solution 10.1 %
27、tetramethylbenzidine (TMB) in5 % acetic acid.7.1.1.2 Solution 23 % hydrogen peroxide solution.7.1.2 Detection of Residues:7.1.2.1 A swab is used to sample nontransparent lumens orsurfaces. Only use a clean cotton swab that does not react withthe test solution. If surfaces are dry, a swab is moistene
28、d witha drop of water. If the surface is wet, the swab need not bepre-moistened.7.1.2.2 Activate 1 mL of Solution 1 with 100 L of Solution2 and drop the swab in the liquid. Blood residue will beindicated by a blue color reaction. Visible color change willoccur at 0.1g or greater.7.2 Screening Test f
29、or Enzymatic Detergents:7.2.1 MethodPrepare enzymatic detergent solution ac-cording to manufacturers recommendations. Enzymatic deter-gents are normally used at 0.5 % (v/v) solutions. Dissolve 500L of enzymatic detergent concentrates in 100-mL flasks andfill up to volume with water of known quality
30、(cleaningefficiency should be compared in demineralized water andwater of standardized hardness). Transfer the solution into100-mL beakers and warm up in a waterbath until the recom-mended temperature has been reached. Usually enzymaticdetergents show best blood-cleaning efficiency at 45C. Insertver
31、tically three test coupons into the detergent solution so thatthe test soil and coupon are completely submerged. No stirring,shaking or any other means of mechanical action should beapplied. Remove the coupons after 15, 30, and 60 min, let dry,and visually inspect for remaining residues (fibrin fibe
32、rs).7.3 Test for Cleaning Effciency of Washer-Disinfectors7.3.1 Method:7.3.1.1 Contaminate surgical instruments by pipette withtest soil prepared in 5.1 and let coagulate and dry. Take carethat critical parts of the instruments are contaminated, forexample, joints or lumen. Specially designed test c
33、ouponsmight be used instead of real instruments.7.3.1.2 Place contaminated instruments or test coupons oninstrument trays and reprocess in the washer-disinfector withthe recommended program for decontamination of contami-nated surgical instruments. Ensure that cannulated instrumentsare connected to
34、the channel irrigation system of the washer.7.3.2 Detection of ResidueInspect instruments or testcoupons for any visible residues and use the peroxidasereaction described in 7.1 for detecting blood residues insideinvisible places (for example, lumens or joints).D72250628. Interpretation of Results8.
35、1 A visual clean surface without detectable traces ofresidues is the optimum result for checking the cleaningefficacy of processes. Additional information regarding theactivity of a detergent or cleaning process can be achieved bythe amount of time needed to completely remove all protein.Visible fib
36、rin (colorless protein) indicates a lack of chemicalcleaning efficacy while visible hemoglobin (red protein resi-due) indicates a lack of water/detergent coverage in a washer.NOTE 1Pure water will give a cleaning efficiency of approximately95 %, leaving only the fibrin fibers behind. An active deter
37、gent needs toclean the test coupons completely, indicating a pass/fail result.9. Keywords9.1 blood cleaning efficiency; detergent; washer-disinfectorASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users
38、 of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every f
39、ive years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical
40、 committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).D7225063
