Executive Summary

This white paper clarifies how to make accurate, harmonised efficacy claims for healthcare disinfectant wipes. It summarises the EN standards that underpin bactericidal, yeasticidal/fungicidal, virucidal, mycobactericidal, and sporicidal claims, explains the Phase 2 Step 1 (suspension) and Phase 2 Step 2 (carrier/surface) testing framework, and provides practical guidance on realistic contact times for wipes in clinical settings. It also demonstrates why ultra-short claims (e.g., “kills in 10 seconds”) are not reliable.

By focusing on wipes (not sprays), this paper equips infection prevention and control (IPC) practitioners with the tools to challenge misleading claims and make informed purchasing decisions.

1. The EN Framework – and Why It Matters for Wipes

EN (European Norm) standards, are technical documents published by the European Committee for Standardisation (CEN) and other organisations that outline requirements for products, services, or processes, promoting safety, quality, and interoperability across Europe.

The EN 14885:2022 outlines the required framework for assessing the efficacy of chemical disinfectants and antiseptics.

Key things to look for in test reports:

• Results must specify the exact EN standard, organism(s), test type (suspension vs carrier), soiling conditions (clean vs dirty), contact time, temperature, and log reduction achieved.
• Suspension tests (Phase 2, Step 1) show a product’s intrinsic activity in a liquid medium.
• Carrier tests (Phase 2, Step 2) model real-life use by testing performance on surfaces.
• For wipes, carrier tests (e.g., EN 16615 for bactericidal/yeasticidal efficacy, EN 17846 for sporicidal wipes) are essential because they incorporate mechanical wiping and transfer assessment.
• Both suspension and carrier testing are needed to demonstrate robust claims.

2. Must-Have EN Standards for Healthcare Wipes

Below are the core standards for disinfectant wipes used on non-porous environmental surfaces in healthcare. Suspension tests provide intrinsic data; wipe-specific carrier tests demonstrate practical performance.

*minimum contact time based on combined claim

For surface disinfectant wipes intended to be used on non-invasive medical devices, the end user should ensure the product carries a valid CE mark and complies with the requirements set out in the Medical Device Regulation (EU) No. 2017/745.

3. Why “Kills in 10 Seconds” or “30 Seconds” Is Usually Misleading for Wipes

Many marketing claims use ultra-short times to attract attention, but they often don’t reflect clinical performance. Reasons include:

1. Method Constraints: EN standards specify contact-time ranges.
   • EN 13727 (bactericidal) – up to 60 min depending on method, ≤5 min typical for healthcare
   • EN 13624 (yeasticidal) – up to 60 min depending on method, ≤5 min typical for healthcare
   • EN 14476 (virucidal): ≤5 min is typical in healthcare.
   • EN 14348 (mycobactericidal): obligatory 60 min, where being used to demonstrate mycobactericidal/tuberculocidal activity, for medical area surface disinfection, contact times shall be adapted according to the principles described in EN 13727 and EN 13624.
   • EN 16615 (4-field sporicidal wipe): 1-60 min depending on method, ≤5 min typical for healthcare.
   • EN 17846 (4 field sporicidal wipes): 1-60 min depending on method, ≤5 min typical for healthcare.
2. Soiling Impact: Dirty conditions (with bovine albumin and erythrocytes) significantly slow kill kinetics. A product claiming “10-second efficacy” is almost always based on clean suspension conditions, which, depending on use is not representative of the products intended use.
3. Mechanical Factors: Wipes must keep surfaces visibly wet for the entire required contact time. In real-world use, factors such as evaporation, the size of the area being wiped, and ventilation mean that ultra-short contact times are often unrealistic.
4. Transfer & Spread: Wipes can transfer organisms. EN 16615 and EN 17846 specifically measure this risk; suspension tests cannot.
5. Organism Differences: Marketing often highlights the fastest kill (e.g., an easy-to-kill bacteria) rather than harder targets like spores, non-enveloped viruses, or mycobacteria, which usually require longer contact times.

Rule of thumb: If a product headlines a “10-second kill,” ask for the test method, organism, soil condition, and where available: whether a wipe-specific carrier method was used under those parameters, as not all tests have a wipe-specific counterpart (e.g., virucidal claims).

4. Best Practice for Presenting Claims

To ensure accuracy and trustworthiness, disinfectant wipe manufacturers should:

1. Always name the EN standard (e.g., EN 16615:2015).
2. List all organisms tested, especially clinically relevant ones.
3. State contact times as validated, not optimised marketing numbers.
4. Include soiling conditions (clean vs dirty).
5. Provide the log reduction as defined by the test standard.

5.  Glossary of Core EN Standards for Wipes

6. Quick-Reference Checklist: How to Read Disinfectant Wipe Claims

Key Takeaways for Healthcare Professionals

• Ask detailed questions: Which EN, which organism, which soil conditions, and  which contact time?
• Look for wipe-specific validation: EN 16615 and EN 17846 are critical for wipes.
• Beware of sub-30s claims: They’re rarely tested according to test method guidance.
• Push for transparency: Accurate data protects patients and supports best practice.
• For non-invasive medical devices: check additional requirements are met, such as CE marking.