The efficacy of a disinfectant does not depend solely on its composition or on the concentration of its active substances. To demonstrate that a product works under specific conditions of use, standardised methods are required to assess its microbiological activity in a reproducible and comparable way.
In this context, EN 13697 is a key standard for evaluating the bactericidal, yeasticidal and/or fungicidal activity of chemical disinfectants used on non-porous surfaces without mechanical action.
This standard mainly applies to products used in food, industrial, domestic and institutional areas, and forms part of the European framework for assessing the efficacy of chemical disinfectants and antiseptics.
What is EN 13697?
EN 13697 describes a quantitative surface test method to evaluate whether a chemical disinfectant shows activity against bacteria, yeasts and/or fungi on non-porous surfaces.
It is a phase 2, step 2 test, which means that it does not simply assess basic antimicrobial activity in suspension. Instead, it aims to simulate practical application conditions more closely.
In the test, microorganisms are placed onto a stainless-steel surface, allowed to dry and then exposed to the disinfectant product for a defined contact time. Afterwards, the action of the product is neutralised and the number of surviving microorganisms is quantified.
This allows the standard to determine whether the product achieves the required microbiological reduction under defined conditions.
Scope of EN 13697
The standard is intended for products used to disinfect non-porous surfaces without mechanical action in areas such as:
- Food industry.
- Food production, distribution and retail.
- Professional kitchens.
- Domestic environments.
- Institutional facilities.
- Public areas.
- Public transport.
- Educational facilities.
- Hotels and offices.
- Cosmetics and toiletries industry.
- Pharmaceutical and biotechnology industries.
- Other industrial environments.
EN 13697 does not apply to situations where disinfection is medically indicated or to products used on living tissues. It is also not intended for products applied through automated airborne disinfection methods, for which specific methods exist.
This distinction matters because efficacy tests are not interchangeable. A product intended for surfaces in the food industry should not be evaluated in the same way as a skin antiseptic or a medical disinfectant, unless there is a clear technical justification.
Relationship between EN 13697 and EN 14885
EN 13697 should be interpreted within the general framework established by EN 14885, which helps identify the applicable European standards according to the product’s intended use, area of application and claimed microbiological activity.
While EN 14885 acts as a framework standard, EN 13697 provides a specific method for evaluating activity on non-porous surfaces without mechanical action.
Before selecting EN 13697 as the test method, it is therefore necessary to define:
- The product’s area of use.
- The type of surface.
- The application method.
- The contact time.
- The temperature of use.
- Clean or dirty conditions.
- The microorganisms against which activity is claimed.
- The activity to be demonstrated: bactericidal, yeasticidal and/or fungicidal.
The choice of method should not be based simply on the fact that a standard “sounds familiar”. That strategy, charmingly human and deeply risky, may lead to results that do not actually support the product claim.
Activities evaluated by EN 13697
The standard can be used to evaluate different types of microbiological activity on non-porous surfaces.
Bactericidal activity
To demonstrate bactericidal activity, the product is tested against representative reference bacteria. The microorganisms included in the standard include:
- Pseudomonas aeruginosa.
- Staphylococcus aureus.
- Enterococcus hirae.
- Escherichia coli.
The product must demonstrate a sufficient reduction of the bacterial population under the selected conditions.
Yeasticidal activity
Yeasticidal activity is evaluated against yeasts, particularly Candida albicans. This activity may be relevant for products intended for surfaces where efficacy against this type of microorganism needs to be demonstrated.
Fungicidal activity
Fungicidal activity includes evaluation against filamentous fungi, such as Aspergillus brasiliensis, as well as yeasts where applicable.
The difference between claiming yeasticidal or fungicidal activity is not a minor detail. Each claim requires specific organisms and criteria and must be supported by appropriate results.
Microbiological reduction requirements
EN 13697 establishes minimum logarithmic reduction requirements for a product to demonstrate activity under the test conditions.
In general:
- For bactericidal activity, a minimum reduction of 4 log is required.
- For yeasticidal and/or fungicidal activity, a minimum reduction of 3 log is required.
These values must be achieved under the tested conditions, including product concentration, contact time, temperature and interfering substance.
For this reason, a positive result should not be interpreted in isolation. The conclusion is always linked to the exact test conditions. A product that demonstrates efficacy at a specific concentration and contact time cannot automatically claim other, more demanding conditions if they have not been tested.
Why test conditions matter
The efficacy of a disinfectant can vary significantly depending on its conditions of use. EN 13697 therefore allows certain parameters to be adapted to reflect the intended use of the product.
The main factors include:
Contact time
The contact time must be consistent with the product’s instructions for use.
If a product claims efficacy in 5 minutes, the test must support that time. A result obtained after 15 minutes cannot automatically justify a shorter application time.
Temperature
The standard includes a range of test temperatures. The selected temperature should reflect the practical conditions under which the product will be used.
Efficacy may be affected by low or high temperatures, so this parameter must be defined carefully.
Clean and dirty conditions
Interfering substances are used to simulate the presence of organic matter or other residues.
The standard includes clean and dirty conditions, as well as a specific condition for dairy industry applications using reconstituted milk.
This is especially relevant in food and industrial environments, where residues may influence the activity of the disinfectant.
Product concentration
The test must be performed at concentrations that make it possible to determine whether the product is active under the proposed conditions.
The tested concentration must be compatible with the use concentration stated in the technical documentation, label or product instructions.
How the EN 13697 test is performed
In summary, the method consists of:
- Preparing a suspension of the test microorganism.
- Mixing it with an interfering substance.
- Applying it to a non-porous stainless-steel surface.
- Allowing the inoculum to dry on the surface.
- Applying the disinfectant product.
- Maintaining contact for the defined time and temperature.
- Neutralising the action of the disinfectant.
- Recovering and quantifying the surviving microorganisms.
- Calculating the logarithmic reduction obtained.
- Determining whether the product meets the criteria of the standard.
This procedure allows the product’s performance to be evaluated in a situation closer to practical application than a suspension test.
Even so, it remains a standardised laboratory test. Its results must therefore be interpreted within the scope of the method and the conditions used.
Relevant changes in EN 13697:2023
The current version of the standard introduces several updates compared with previous versions.
The most relevant changes include:
- Explicit inclusion of yeasticidal activity in the title.
- Adjustments to test parameters under clean conditions for certain microorganisms.
- More precise control of the drying process.
- Inclusion of Listeria monocytogenes as an additional organism.
- Clarifications in the counting procedure.
- Corrections to formulas and calculation criteria.
- Harmonisation of variables with other methods developed by CEN/TC 216.
- Clarification on the use of reconstituted milk as an interfering substance in dairy applications.
These updates help improve the reproducibility of the test and reduce possible ambiguities during the execution of the method.
Common mistakes when interpreting EN 13697
When designing an efficacy strategy, several mistakes may affect the validity of the product claims.
Some of the most common are:
- Using EN 13697 without confirming that the product is intended for non-porous surfaces.
- Failing to distinguish between bactericidal, yeasticidal and fungicidal activity.
- Claiming contact times that are not supported by the test.
- Testing clean conditions when the intended use requires dirty conditions.
- Transferring results to other areas of application without justification.
- Confusing a surface test without mechanical action with methods that include wiping or rubbing.
- Failing to consider whether the product will be used in food, dairy, domestic or institutional settings.
- Not checking whether the version of the standard used is up to date.
The correct method should be selected before testing begins, not once the product already has a label, technical data sheet and commercial promises carved into stone, because apparently we enjoy making life harder than necessary.
EN 13697 and proficiency testing programmes
In addition to being relevant for manufacturers and laboratories conducting efficacy studies, EN 13697 may also form part of a laboratory’s proficiency testing participation strategy.
Proficiency testing allows laboratories to compare their performance with that of other participants and obtain an external, independent assessment of their technical competence.
At SHAPYPRO, laboratories can consult the Upcoming Proficiency Testing Programs and select the EN standards of interest through the form available on the website. This page allows laboratories to request participation in programmes related to different European methods and activities for disinfectants and antiseptics, including standards linked to surface disinfection such as EN 13697.
Integrating these programmes into the laboratory’s annual planning helps to:
- Assess the correct application of the method.
- Compare results with other laboratories.
- Detect technical deviations.
- Strengthen confidence in the results issued.
- Obtain evidence for audits and quality systems.
- Plan participation according to the laboratory’s technical areas.
For laboratories working with disinfectant efficacy methods, participation in proficiency testing programmes should not be seen as an isolated requirement, but as a tool to demonstrate competence and improve control of the analytical process.
How SHAPYPRO can help
SHAPYPRO works with laboratories and companies that need to interpret and apply European standards related to the efficacy of chemical disinfectants and antiseptics.
In relation to EN 13697, SHAPYPRO can support with:
- Interpretation of the method and its scope.
- Selection of applicable standards within the EN 14885 framework.
- Design of testing strategies according to the product’s intended use.
- Evaluation of contact time, concentration, temperature and interfering substances.
- Organisation of proficiency testing programmes related to European efficacy standards.
- Technical support for laboratories seeking to strengthen their competence through PT participation.
This approach connects efficacy evaluation with the technical reality of the product and the needs of laboratories applying these methods.
Conclusion
EN 13697 is an essential standard for evaluating the bactericidal, yeasticidal and/or fungicidal activity of chemical disinfectants on non-porous surfaces without mechanical action.
Its correct application requires a precise definition of the product’s intended use, the activity to be claimed, the relevant microorganisms and the test conditions.
A result compliant with EN 13697 can support efficacy claims, provided that the tested conditions match the actual instructions for use of the product.
For laboratories, this standard also represents a relevant area within proficiency testing planning. Participation in PT programmes associated with methods such as EN 13697 makes it possible to assess performance, strengthen technical competence and improve confidence in results.
In biocidal efficacy, the difference between a solid claim and a weak statement often lies in the details: the correct method, appropriate conditions, rigorous interpretation and well-documented evidence.