The EN 14885 standard establishes general guidelines for the application of European standards related to chemical disinfectants and antiseptics. It is a key document for manufacturers, laboratories, and professionals in the healthcare and industrial sectors, ensuring that the products used meet the efficacy and safety requirements demanded in Europe.
In this article, we analyze in detail the EN 14885 standard, its scope, its relationship with other specific standards, and its importance in ensuring the effectiveness of disinfectant products across different areas of use.
What is EN 14885?
The EN 14885:2023 is a European standard that specifies the requirements and recommendations for applying efficacy standards for chemical disinfectants and antiseptics. Its main objective is to ensure that products are evaluated consistently and reliably, following scientifically validated methods.
This standard does not define efficacy criteria but establishes how the specific standards should be applied for each type of use (medical, veterinary, industrial, domestic, etc.) and target microorganism.
Application Areas of EN 14885
The standard clearly differentiates the areas where disinfectants are applied:
- Medical area: hospitals, clinics, medical offices, clinical laboratories.
- Veterinary area: animal facilities, veterinary clinics, animal transport.
- Food, industrial, domestic, and institutional areas: food production plants, industrial kitchens, public spaces, among others.
Each area has specific requirements, and EN 14885 provides guidance on which standards should be applied to evaluate product efficacy in each case.
Relationship with Other European Standards
EN 14885 acts as an umbrella standard that groups and contextualizes other specific standards, such as:
- EN 13697: efficacy on non-porous surfaces without mechanical action.
- EN 13727: bactericidal efficacy in the medical area.
- EN 13624: fungicidal and yeasticidal efficacy in the medical area.
- EN 14476: virucidal efficacy.
Each of these standards defines specific test methods to verify efficacy against specific types of microorganisms (bacteria, fungi, viruses, spores, etc.), under controlled and representative usage conditions.
The Importance of a Phase-Based Approach
EN 14885 establishes a phase-based approach for efficacy evaluation:
- Phase 1: basic in vitro (suspension) tests to verify antimicrobial activity.
- Phase 2, Step 1: tests under practical usage conditions without mechanical action.
- Phase 2, Step 2: tests simulating real-life conditions with mechanical action (e.g., rubbing).
- Phase 3: field tests, not standardized, that may be required by national authorities.
This approach ensures that products are effective not only in the laboratory but also under actual usage conditions.
Benefits of Complying with EN 14885
Compliance with EN 14885 offers multiple benefits:
- Market trust: demonstrates that the product has been evaluated with validated methods.
- Regulatory compliance: required for CE marking on biocidal products.
- User safety: ensures efficacy against pathogenic microorganisms.
- Access to public tenders and contracts: many institutions require this compliance.
Moreover, EN 14885 promotes harmonization across Europe, facilitating the commercialization of disinfectant products in different countries.
Key Updates in the 2023 Version
The latest revision of the standard (EN 14885:2023) introduces significant updates:
- Clarification of applicable tests based on the application field.
- Inclusion of new relevant microorganisms based on current needs (such as emerging viruses).
- Improved description of the phase-based approach and its applicability.
- Terminology revisions for greater consistency with biocide regulations (BPR – EU Regulation 528/2012).
Practical Application in Laboratories and Companies
At SHAPYPRO, we hold a specific accreditation in disinfectant efficacy testing according to EN 14885, which ensures our technical competence and the reliability of the results obtained. This accreditation supports our testing procedures and guarantees compliance with the highest quality standards.
Manufacturers of disinfectants and testing laboratories must follow EN 14885 as a guide for planning and conducting efficacy studies. This involves:
- Selecting appropriate specific standards based on the application area.
- Designing tests according to the phase-based approach.
- Properly documenting results and their interpretation.
Additionally, SHAPYPRO organizes proficiency testing schemes for disinfectants according to EN 14885, offering laboratories the opportunity to:
- Verify their technical competence under controlled conditions.
- Benchmark their results against other laboratories in the sector.
- Improve their testing procedures and traceability.
- Meet external competence evaluation requirements.
Participating in these proficiency tests not only reinforces the reliability of laboratory results but also serves as a key tool for technical recognition in the sector.
👉 For more information, explore our proficiency testing services or contact us.
Additional Resources
For more information on biocide regulation in Europe, you can visit the European Chemicals Agency (ECHA).
Conclusion
The EN 14885 standard is a fundamental pillar for ensuring the efficacy and safety of disinfectants and antiseptics in Europe. Its correct application enables manufacturers and laboratories to guarantee the quality of their products and comply with legal and market requirements.
In an environment where hygiene and infection prevention are priorities, correctly applying EN 14885 is not just a regulatory obligation but also a mark of trust for end users.