Healthcare Personnel Hand Wash Testing (ASTM 1174 & EN 1499)

Validating Rinse-Off Antiseptic Efficacy for Global Markets

Healthcare personnel hand wash products—such as antiseptic soaps and cleansing formulations—serve as the first line of defence against infection in clinical and food service settings. Verifying their antimicrobial efficacy is a crucial step for both regulatory compliance and public confidence.

Eurofins CRL offers testing in accordance with both the primary North American and European standards, providing the comprehensive data required for a global product launch through a single laboratory partner.

ASTM 1174: The FDA Standard for Healthcare Hand Wash

Purpose

The ASTM 1174 standard is the in vivo test method recognised by the U.S. Food and Drug Administration (FDA) to demonstrate the antimicrobial effectiveness of healthcare personnel hand wash formulations. It assesses a product’s ability to reduce transient microbial flora on the hands, simulating real-world use under controlled clinical conditions.

Methodology

The ASTM 1174 procedure is conducted using human volunteers. The main stages include:

• Conditioning Wash: Participants’ hands are first cleansed with a non-antimicrobial soap to remove surface oils and debris.
• Contamination: Hands are artificially contaminated with a high concentration of a non-pathogenic marker bacterium, typically Serratia marcescens or Escherichia coli.
• Baseline Sampling: A baseline microbial count is established prior to product use, usually using the “glove juice” method.
• Product Use: Participants use the test product following a standardised washing and rinsing protocol.
• Post-Wash Sampling: The surviving organisms are recovered using the same method as the baseline.
• Calculation: Log reductions are calculated by comparing pre- and post-wash microbial counts.

Regulatory Significance

This test is essential for companies developing hand hygiene products for the North American market. Regulatory authorities often require a minimum log reduction in bacterial load—such as a 3-log₁₀ reduction (99.9%)—to demonstrate antimicrobial efficacy.

EN 1499: The European Standard for Hygienic Hand Wash

Purpose

EN 1499 is the European reference method for evaluating rinse-off hygienic hand wash products. Classified as a phase 2, step 2 in vivo test, it assesses performance under simulated practical conditions. Passing this standard is crucial for gaining market access within the European Union.

Methodology

While also focused on antimicrobial effectiveness, EN 1499 differs from ASTM 1174 in its comparative nature. The main procedural steps include:

• Contamination: Hands of 12–15 volunteers are contaminated with Escherichia coli K12.
• Comparative Wash: The product’s performance is compared to a reference soft soap by evaluating mean log reduction values.
• Performance Criterion: The product must demonstrate a statistically significant superior bacterial
  reduction compared with the reference soap.
  
  

Key Differences: ASTM (1174 vs EN 1499)

FAQs

Q1. What is the purpose of ASTM 1174 in antimicrobial effectiveness testing?

ASTM 1174 is the FDA-recognised standard used in the U.S. to measure how effectively a healthcare hand wash product reduces bacteria on the hands under real-use conditions.

Q2. How is hand wash testing different from other types of antimicrobial testing?

Hand wash testing, such as ASTM 1174 or EN 1499, focuses on immediate antimicrobial performance on the skin, while other methods may evaluate product effectiveness on surfaces or under storage conditions.

Q3. Why is antimicrobial efficacy testing important for hand hygiene products?

It ensures that hand hygiene formulations deliver reliable protection by effectively reducing transient microorganisms, thereby helping to prevent cross-contamination and infection.

Q4. What is the key difference between ASTM 1174 and EN 1499?

ASTM 1174 measures the quantitative log reduction of bacteria, whereas EN 1499 compares the product’s performance against a standard reference soap.

Q5. Do I need both ASTM 1174 and EN 1499 testing for global compliance?

Yes. To market healthcare personnel hand wash products worldwide, both standards are typically required—ASTM 1174 for North America and EN 1499 for Europe—ensuring full regulatory coverage and consumer confidence.

Ensure Global Compliance- Request your hand wash testing consultation today.