ASTM E1174 Healthcare Personnel Handwash Efficacy Testing
ASTM E1174 test method determines the effectiveness of hand-washing agents by testing their ability to reduce transient microbial flora during their use in a hand-washing procedure. The final results of this method are displayed keeping in view the international standards and inch-pound units.
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- Overview
- Scope, Applications, and Benefits
- Test Process
- Specifications
- Instrumentation
- Results and Deliverables
Overview
ASTM E1174 defines a standardized in vivo method to evaluate the antimicrobial effectiveness of handwash formulations intended for healthcare personnel. The method measures the reduction of transient microbial flora on hands after controlled contamination and subsequent washing with the test product.
This standard is widely used to validate hand hygiene products in clinical environments, ensuring they effectively reduce microbial load and minimize the risk of cross-contamination. ASTM E1174 supports regulatory requirements, product development, and comparative performance evaluation by providing reproducible and quantitative efficacy data under realistic usage conditions.
Scope, Applications, and Benefits
Scope
ASTM E1174 establishes procedures to assess the effectiveness of healthcare handwash formulations by measuring microbial reduction on human hands after artificial contamination and washing. It ensures controlled testing conditions for reliable and repeatable results.
- Evaluates removal of transient microorganisms from hands
- Uses artificial contamination with specified microbial strains
- Measures immediate antimicrobial effectiveness after washing
- Applicable to healthcare handwash and antiseptic formulations
- Requires human subjects and microbiological analysis
Applications
- Validation of healthcare handwash formulations
- Evaluation of antiseptic hand hygiene products
- Regulatory compliance and product approval
- Infection control product development
- Comparative testing of antimicrobial formulations
- Quality assurance in hygiene products
Benefits
- Provides standardized evaluation of handwash efficacy
- Ensures reliable reduction of transient microbial contamination
- Supports regulatory approval and labeling claims
- Enables comparison between different formulations
- Enhances infection control practices in healthcare settings
- Improves product development and optimization
Test Process
Hand Contamination
Subjects’ hands are artificially contaminated with a known concentration of test microorganisms.
1Product Application
The handwash formulation is applied under defined conditions and washing procedure.
2Microbial Recovery
Surviving microorganisms are recovered using standardized sampling methods.
3Enumeration and Analysis
Microbial counts are determined to calculate log reduction achieved by the product.
4Technical Specifications
| Parameter | Details |
|---|---|
| Standard | ASTM E1174 |
| Test Principle | In vivo measurement of microbial reduction after handwashing following artificial contamination |
| Applicable Products | Healthcare handwash and antiseptic formulations |
| Test Type | Human subject-based microbiological efficacy test |
| Measurement Output | Log₁₀ reduction in transient microbial population |
| Test Organism | Typically Serratia marcescens or equivalent indicator organism |
| Inoculum Level | High microbial load (typically ≥10⁸ CFU/mL contamination suspension) |
Instrumentation Used for Testing
- Handwashing station with controlled water supply
- Sterile gloves and sampling containers
- Microbial culture media and Petri dishes
- Incubator for microbial growth
- Pipettes and dilution systems
- Colony counter
- Laminar airflow cabinet
- Data recording system
Results and Deliverables
- Log reduction values of test microorganisms
- Handwash efficacy performance data
- Comparative formulation analysis
- Test report with methodology and conditions
- Compliance verification with ASTM E1174
- Data supporting regulatory submissions
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Frequently Asked Questions
The method uses controlled artificial contamination with high microbial loads to mimic worst-case exposure scenarios, ensuring that handwash formulations are evaluated under rigorous conditions representative of healthcare environments.
Serratia marcescens is easily distinguishable, non-pathogenic under test conditions, and provides consistent recovery, making it suitable for evaluating handwash effectiveness without compromising subject safety.
The method primarily measures reduction in recoverable organisms, which includes both physical removal and antimicrobial action. Additional studies may be required to distinguish between these mechanisms.
High microbial loads create a stringent challenge, ensuring that only effective formulations demonstrate significant reduction, thereby validating product performance under demanding conditions.
The glove juice technique ensures thorough recovery of microorganisms from the entire hand surface by mechanical agitation, reducing variability and improving reliability of microbial counts.
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