iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM E1482-04

(Test Method)

Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations

Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations

SIGNIFICANCE AND USE
This test method is to be used for the removal of virucidal agents from agent-virus mixtures, or from agent-neutralizer-virus mixtures, after the contact period and before the inoculation of these mixtures into host systems for assay of infectivity.
The purpose of the test method is to reduce the concentration of agents and neutralizers in order to permit the evaluation of viral infectivity at dilutions that would otherwise be toxic to the host.
The test method is applicable to the testing of liquid and pressurized disinfectant products.
This test method is compatible with organic soil loads, hard water, disinfectants containing organic solvents, and chemical neutralizers.
SCOPE
1.1 This test method covers the use, in conjunction with evaluations of the virucidal efficacy, of disinfectant solutions or pressurized disinfectant spray products intended for use on inanimate nonporous environmental surfaces or for other special applications. The test method may be employed with all viruses and host systems.
1.2 This test method should be performed only by persons trained in microbiology and virology.
1.3 This test method utilizes gel filtration technology. The effectiveness of the test method is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns and centrifugation conditions. The effectiveness of this test method is maximized by investigator practice and experience with gel filtration techniques.
1.4 This test method will reduce, but not necessarily eliminate, disinfectant toxicity while preserving the titer of input virus.
1.5 The values stated in SI units are to be regarded as the standard.
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 determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
30-Sep-2004
ICS
11.080.20 - Disinfectants and antiseptics
71.100.35 - Chemicals for industrial and domestic disinfection purposes
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaces
ASTM E1482-92(2004) - Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
Effective Date
01-Oct-2004
Replaced By
ASTM E1482-12 - Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
Effective Date
01-Oct-2012
Referred By
ASTM E2011-21 - Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand
Effective Date
01-Oct-2004
Referred By
ASTM E1052-20 - Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension
Effective Date
01-Oct-2004
Referred By
ASTM E1054-22 - Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
Effective Date
01-Oct-2004
Referred By
ASTM E1053-20 - Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
Effective Date
01-Oct-2004

Buy Standard

ASTM E1482-04 - Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy EvaluationsASTM E1482-04 - Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
PreviousNext
Standard
ASTM E1482-04 - Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations
English language
3 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1482 − 04
StandardTest Method for
Neutralization of Virucidal Agents in Virucidal Efficacy
1
Evaluations
This standard is issued under the fixed designation E1482; 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 cals Intended for Disinfection of Inanimate, Nonporous
Environmental Surfaces
1.1 This test method covers the use, in conjunction with
evaluationsofthevirucidalefficacy,ofdisinfectantsolutionsor
3. Summary of Test Method
pressurized disinfectant spray products intended for use on
3.1 After the exposure of a virus to a disinfectant, the
inanimate nonporous environmental surfaces or for other
virus-disinfectant suspension is applied to a column of Sepha-
specialapplications.Thetestmethodmaybeemployedwithall
3
dex LH60-120,orSephacrylS-1000Superfine.Thecolumnis
viruses and host systems.
placed in a centrifuge and centrifuged to separate the virus
1.2 This test method should be performed only by persons
from the disinfectant by gel filtration. The filtrate (the column
trained in microbiology and virology.
flow-through that contains the virus) is assayed in the appro-
1.3 This test method utilizes gel filtration technology. The
priate host system. The untreated virus control suspension is
effectivenessofthetestmethodisdependentontheratioofgel
similarly gel filtered, and the virus titer of the filtrate is
bedvolumetosamplesizeanduniformityinthepreparationof
determined by assay of infectivity.The residual cytotoxicity of
columns and centrifugation conditions. The effectiveness of
the disinfectant is determined by gel filtration of the disinfec-
this test method is maximized by investigator practice and
tant control under the same conditions. Results for the virus
experience with gel filtration techniques.
inactivation and disinfectant cytotoxicity of gel filtrates are
recorded in the same manner as described in Test Methods
1.4 This test method will reduce, but not necessarily
E1052 and E1053. The gel filtration procedures described in
eliminate, disinfectant toxicity while preserving the titer of
this test method are a modification of the method of Blackwell
input virus.
4
and Chen.
1.5 The values stated in SI units are to be regarded as the
standard.
4. Significance and Use
1.6 This standard does not purport to address all of the
4.1 This test method is to be used for the removal of
safety concerns, if any, associated with its use. It is the
virucidal agents from agent-virus mixtures, or from agent-
responsibility of the user of this standard to establish appro-
neutralizer-virus mixtures, after the contact period and before
priate safety and health practices and determine the applica-
theinoculationofthesemixturesintohostsystemsforassayof
bility of regulatory limitations prior to use.
infectivity.
2. Referenced Documents
4.2 The purpose of the test method is to reduce the concen-
2
tration of agents and neutralizers in order to permit the
2.1 ASTM Standards:
evaluation of viral infectivity at dilutions that would otherwise
E1052Test Method to Assess the Activity of Microbicides
be toxic to the host.
against Viruses in Suspension
E1053Test Method to Assess Virucidal Activity of Chemi-
4.3 Thetestmethodisapplicabletothetestingofliquidand
pressurized disinfectant products.
4.4 This test method is compatible with organic soil loads,
1
This test method is under the jurisdiction of ASTM Committee E35 on
hard water, disinfectants containing organic solvents, and
Pesticides and Alternative Control Agentsand is the direct responsibility of Sub-
committee E35.15 on Antimicrobial Agents.
chemical neutralizers.
Current edition approved Oct. 1, 2004. Published October 2004. Originally
approved in 1992. Last previous edition approved in 2004 as E1482-92 (2004).
DOI: 10.1520/E1482-04.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Sephadex is a registered trademark of Amersham Biosciences.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Blackwell,H.H.,andChen,J.H.S.,“EffectsofVariousGermicidalChemicals
Standards volume information, refer to the standard’s Document Summary page on on H.EP.2 Cell Culture and Herpes simplex Virus,” Journal of the AOAC, Vol 53,
the ASTM website. 1970, pp. 1229–1236.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1482 − 04
5. Reagents and Materials (0.6mLofsampletobeadded);a10-ccsyringeisusedfor6-cc
columns(1.2mLofsampletobeadded).Removethecapfrom
5.1 Reagents:
thesyringetip,removetheplung
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM E1482-23(Practice)
Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

SIGNIFICANCE AND USE
5.1 This practice is to be used for the removal of virucidal agents from test product-virus mixtures, or from test product-neutralizer-virus mixtures, at or after the contact period and before the inoculation of these mixtures into host systems for assay of viral infectivity.  
5.2 The purpose of the practice is to reduce the concentration of the cytotoxic properties of the test product and neutralizers in order to permit the evaluation of viral infectivity at dilutions that would otherwise be toxic to the host cells.  
5.3 The practice is applicable to the testing of liquid, pre-saturated towelettes, and pressurized disinfectant products, as well as handwash/rub products.  
Note 3: When testing products, the ability of the solution to pass through the column must be verified prior to testing. Certain products with high viscosities are unable to pass through columns. If the product is determined to be too viscous, alternative neutralization methods should be employed.  
5.4 This practice is compatible with organic soil loads, hard water, disinfectants containing organic solvents, and chemical neutralizers.
SCOPE
1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems.
Note 1: Gel filtration columns may impact virus titer and their use should be taken into consideration when selected for use.  
1.2 This practice should be performed only by persons trained in virology techniques.  
1.3 This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of centrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques.  
1.4 This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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.

  • Standard
    3 pages
    English language
    sale 15% off
  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM E1054-22(Practice)
Standard Practices for Evaluation of Inactivators of Antimicrobial Agents

SIGNIFICANCE AND USE
5.1 The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their ability to kill microorganisms within a specified contact time. Hence, accurate determination of antimicrobial effectiveness requires complete and immediate inactivation (neutralization) of the antimicrobial agent. Inefficient or incomplete neutralization will permit killing or inactivation of microorganisms to continue beyond the experimental exposure time, resulting in an overestimation of antimicrobial activity.  
5.2 The neutralization methods commonly used in antimicrobial effectiveness evaluations are chemical inactivation, dilution, and filtration. All critical parameters of an antimicrobial effectiveness evaluation—for example, media, equipment, microorganism(s), and temperature of solutions—must be duplicated in the performance of selected neutralization procedure.  
5.3 The neutralization evaluation must include at least three replications (five replications in Section 9) so that a statistical analysis of the microbial recovery data can be performed. The number of replicates used in the evaluation depends on the statistical significance required for the expected results, the variability encountered in the data, and the relative effectiveness of the neutralization procedure.  
5.4 A limitation of these evaluation procedures is that they use microorganisms that have not been exposed to an antimicrobial agent. Under experimental conditions, cells exposed to neutralization procedures are likely to be damaged to different degrees by the antimicrobial agent. Sublethal injury may be a factor in recovery, and the effect of the neutralization procedure on recovery of injured organisms should be examined. This method is not intended to assess recovery of injured organisms.
Note 3: Ideally, all microorganisms used in the antimicrobial effectiveness evaluation should be tested in the neutralization assay. However, representative organism...
SCOPE
1.1 These test procedures are used to determine the effectiveness of methodologies procedures and materials intended for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents; to ensure that no components of the neutralizing procedures and materials, themselves, exert an inhibitory effect on microorganisms targeted for recovery; and to demonstrate that the antimicrobial chemistry tested is microbicidal.  
1.2 Knowledge of microbiological and statistical techniques is required for these procedures.
Note 1: These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

  • Standard
    10 pages
    English language
    sale 15% off
  • Standard
    10 pages
    English language
    sale 15% off
ASTM
ASTM E1153-22(Test Method)
Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

SIGNIFICANCE AND USE
4.1 This test method shall be used to determine if a chemical intended for use as a non-food contact sanitizer or as a one-step cleaner-sanitizer provides percent reductions of the selected test organisms on treated carriers as compared to control.
SCOPE
1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelette-based antimicrobial products, modifications may also be required.  
1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner-sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces.  
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them where appropriate (see section 40 CFR, 160 or as revised.)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard may involve hazardous materials, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training.  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.  
1.6 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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E2755-22(Test Method)
Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults

SIGNIFICANCE AND USE
5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms. Hand rubs reduce the microbial load on the hands without the use of soap and water, and are thus an important tool in the practice of good hand hygiene. Alcohol-based hand rubs are recommended in healthcare settings for use on hands that are not visibly soiled. They are formulated to be applied full strength to dry hands, “rubbed in” until dry, and are not rinsed off.  
5.2 This test method is designed specifically to evaluate hand rubs for efficacy in eliminating bacteria from experimentally-contaminated hands. It is designed as an alternative to Test Method E1174, which was intended primarily to evaluate antimicrobial handwashing agents that are lathered with the aid of water and then rinsed off. When using Test Method E1174 to evaluate hand rubs, inadequate drying of the hands after contamination dilutes the test material and can compromise activity, to result in an underestimation of effectiveness. Additionally, because hand rubs are not rinsed after product use, activity can be further degraded by build-up of soil from the contaminating broth and inactivated challenge bacteria on the hands.  
5.2.1 In this method, application to the hands of a small volume of high-titer test bacteria suspension minimizes soil load such that the skin is completely dry prior to application of the test material. Further, by applying the bacterial suspension only prior to those test material application cycles followed by sampling, excessive buildup of killed bacteria on the hands is avoided, and the potential impact of non-volatile test product ingredients on bacteria-eliminating effectiveness after ten consecutive applications can be specifically assessed.  
5.3 A reference control is evaluated for each subject prior to evaluation of the test material. Data from the reference control helps to control for inter-subject variability, inter-experimental variabi...
SCOPE
1.1 This test method is designed to determine the activity of healthcare personnel hand rubs, (also known as hand rubs, hygienic hand rubs, hand sanitizers, or hand antiseptics) against transient microbial skin flora on the hands after a single application and after repeated applications.  
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56).  
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2.2,3  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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 more specific precautionary statements, see 8.2.  
1.6 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.

  • Standard
    7 pages
    English language
    sale 15% off
  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM E3178-18(Practice)
Standard Practice for Evaluating Static and Cidal Chemical Decontaminants against Bacillus Spores using Centrifugal Filtration Tubes

SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be small enough to fit inside filter units mentioned in 4.1.  
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, and safe, while minimizing labor and addressing statistical confidence (1, 2).  
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that all the spores were accounted for.  
5.2.2 Statistical Confidence—The use of five independent preparations of spore inocula for a statistical n of 5.  
5.2.3 Sensitivity—Allows for complete detection of all culturable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.3.1 The limit of detection is dependent on the culturability of fully matured spores to germinate, outgrow and divide in the presence of the extraction medium (1% tryptic soy broth, 100 mM L-Alanine, 1 mM inosine, 0.05% Tween 80) and/or on tryptic soy agar.
5.2.3.2 Results presented in Refs (1, 3) (and currently unpublished results) indicate that these media, combined with the test temperatures and conditions described herein will generate results with a high level of practical confidence for detecting culturable Bacillus spores.  
5.2.4 Safety—Inoculated coupons are contained within filter units.  
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same filter unit to minimize coupon handling steps.  
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1, 2).  
5.2.7 Wide application for numerous Bacillus species and strains. The method has also been modified and used for vegetative bacteria and viruses as well (1, 2).
SCOPE
1.1 This practice is used to quantify the efficacy of liquid or solid decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials. This practice can distinguish between bactericidal and bacteriostatic chemicals within decontamination mixtures. This is important because many decontaminants contain both reactive compounds and high concentrations of bacteriostatic surfactants. All test samples are directly compared to pre-neutralized controls, un-inoculated negative growth controls, and solution controls on the same day as the test in order to increase practical confidence in the inactivation data.  
1.2 This procedure should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and the application instructions of the antimicrobial products.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard may involve hazardous materials, operations, and equipment. 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.  
1.5 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.

  • Standard
    11 pages
    English language
    sale 15% off
ASTM
ASTM E3092-18(Practice)
Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with Bacillus Spores and Contained Within 0.2µm Filter-Capped Tubes

SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube.  
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence (1, 2, 4).  
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed.  
5.2.2 Statistical Confidence—The use of five independent preparations of spore inoculum for a statistical N of 5.  
5.2.3 Sensitivity—Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon.  
5.2.4 Safety—Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains.  
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps.  
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1-3).  
5.2.7 Wide application for numerous Bacillus species and strains.
Note 1: This practice differs from similar quantitative methods (E2111, E2197 and E2414) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.
SCOPE
1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes.  
1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E1115-11(2017)(Test Method)
Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

SIGNIFICANCE AND USE
5.1 The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.
SCOPE
1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR, Parts 50 and 56)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses.  
1.5 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.  
1.6 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.

  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E2752-10(2015)(Guide)
Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products

SIGNIFICANCE AND USE
5.1 The procedure is used to evaluate personal cleansing products containing antibacterial ingredients that are intended to reduce the number of organisms on intact skin. It also may be used to demonstrate the effect of residual antibacterial activity by means of inhibition of the proliferation of bacteria on the skin after contact.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing product in reducing the numbers of a marker organism (representing transients) both immediately and after prolonged exposure to (cleansing) washing when used as recommended under simulated use conditions. The method demonstrates the effect of residual antibacterial activity by means of inhibition of proliferation of bacteria on the skin after the contact period. Antimicrobial activity is compared with a vehicle or to a baseline organism count.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR Parts 50 and 56).  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard may involve hazardous materials, operations, and equipment. 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 determine the applicability of regulatory limitations prior to use.

  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM E1482-23(Practice)
Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

SIGNIFICANCE AND USE
5.1 This practice is to be used for the removal of virucidal agents from test product-virus mixtures, or from test product-neutralizer-virus mixtures, at or after the contact period and before the inoculation of these mixtures into host systems for assay of viral infectivity.  
5.2 The purpose of the practice is to reduce the concentration of the cytotoxic properties of the test product and neutralizers in order to permit the evaluation of viral infectivity at dilutions that would otherwise be toxic to the host cells.  
5.3 The practice is applicable to the testing of liquid, pre-saturated towelettes, and pressurized disinfectant products, as well as handwash/rub products.  
Note 3: When testing products, the ability of the solution to pass through the column must be verified prior to testing. Certain products with high viscosities are unable to pass through columns. If the product is determined to be too viscous, alternative neutralization methods should be employed.  
5.4 This practice is compatible with organic soil loads, hard water, disinfectants containing organic solvents, and chemical neutralizers.
SCOPE
1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems.
Note 1: Gel filtration columns may impact virus titer and their use should be taken into consideration when selected for use.  
1.2 This practice should be performed only by persons trained in virology techniques.  
1.3 This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of centrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques.  
1.4 This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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.

  • Standard
    3 pages
    English language
    sale 15% off
  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM E1153-22(Test Method)
Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

SIGNIFICANCE AND USE
4.1 This test method shall be used to determine if a chemical intended for use as a non-food contact sanitizer or as a one-step cleaner-sanitizer provides percent reductions of the selected test organisms on treated carriers as compared to control.
SCOPE
1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelette-based antimicrobial products, modifications may also be required.  
1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner-sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces.  
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them where appropriate (see section 40 CFR, 160 or as revised.)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard may involve hazardous materials, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training.  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.  
1.6 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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off