Understanding SR EN 14885:2022 in the medical field
The European standard EN 14885:2022 is the reference document for evaluating the efficacy of chemical disinfectants and antiseptics in the medical field. This article guides you through the essential requirements for the validation and correct use of disinfectant products in medical practice, ensuring the safety of both patients and medical staff.
The medical area encompasses all spaces and situations where disinfection or antisepsis is medically necessary: hospitals, polyclinics and medical offices, dental clinics, analysis laboratories, infirmaries in schools and nursing homes, as well as laundries and kitchens serving patients.
Table of Contents
1. Structure of the testing system
2. Fields of application in the medical area
2.1. Hygienic hand disinfection
2.2. Surgical hand disinfection by rubbing and washing
2.3. Disinfection of medical instruments
2.4. Surface disinfection
2.5. Airborne room surface disinfection (via nebulization)
2.7. Water treatment for Legionella control
1. Structure of the testing system
The standard organizes tests into a modular three-phase system, each with a specific purpose:
Phase 1 - Preliminary tests: Establish the basic microbicidal activity of the active substance, without reference to specific applications. These tests CANNOT be used for product claims.
Phase 2, Step 1 - Quantitative suspension tests: Demonstrate that the product has bactericidal, fungicidal, virucidal, etc., activity under simulated practical conditions relevant to its intended use.
Phase 2, Step 2 - Practical application tests: Evaluate the activity of the product applied to surfaces, instruments, textiles, or skin, under conditions simulating real use (e.g., hand, surface, or instrument disinfection tests).
Important: In general, BOTH types of tests (Phase 2 Step 1 AND Phase 2 Step 2) are required to support the efficacy claims of a chemical disinfectant or antiseptic.
2. Fields of application in the medical area
The standard defines specific tests for each medical application. Here are the most relevant ones for your practice:
2.1. Hygienic hand disinfection
By rubbing
For products applied by rubbing without water, the mandatory standards are:
• EN 13727 (Phase 2/1) - bactericidal activity under clean conditions (0.3 g/l bovine albumin),
• EN 1500 (Phase 2/2) - bactericidal activity, skin test, with a contact time between 30 seconds and 1 minute
Passing criteria: The product must be at least as effective as 60% v/v propan-2-ol applied 2×3 ml for 30 seconds each.
• EN 13624 (Phase 2/1) - yeasticidal activity under clean conditions (0.3 g/l bovine albumin)
Additional standards (optional):
• EN 14348 (Phase 2/1) - tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1) - virucidal activity against enveloped viruses / limited spectrum virucidal activity / general virucidal activity
By washing
For products applied by washing and rinsing with water, the mandatory standards are:
• EN 13727 (Phase 2/1) – bactericidal activity under dirty conditions (3.0 g/l bovine albumin + 3 ml/l sheep erythrocytes)
• EN 1499 (Phase 2/2) - bactericidal activity, by comparing the product to a reference soap, skin test, with a contact time between 30 seconds and 1 minute
• EN 13624 (Phase 2/1) - yeasticidal activity under dirty conditions (3.0 g/l bovine albumin + 3 ml/l sheep erythrocytes)
Additional standards (optional):
• EN 14348 (Phase 2/1) - tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1) - virucidal activity against enveloped viruses, tested at 50% product concentration, with a minimum logarithmic reduction of 2 lg
2.2. Surgical hand disinfection by rubbing and washing
For the preoperative preparation of the surgeon's hands, the mandatory standards are:
• EN 13727 (Phase 2/1) - bactericidal activity under clean conditions (0.3 g/l bovine albumin, by rubbing) and under dirty conditions (3.0 g/l bovine albumin + 3 ml/l sheep erythrocytes, by washing)
• EN 12791 (Phase 2/2) - evaluates the immediate effect and the sustained effect after 3 hours
Pass criteria:
o Immediate effect: the product must be at least as effective as propan-1-ol 60% v/v, applied n × 3 ml for 3 minutes, tested on skin between 1 and 5 minutes
o Effect after 3 hours: the product must be at least as effective as propan-1-ol 60% v/v
• EN 13624 - yeasticidal activity under clean conditions (0.3 g/l bovine albumin, by rubbing) and under dirty conditions (3.0 g/l bovine albumin + 3 ml/l sheep erythrocytes, by washing)
Important note: According to the current state of science, activity against fungal spores, mycobacteria, and viruses is not considered relevant for surgical hand disinfection.
2.3. Disinfection of medical instruments
For immersion disinfection of medical instruments, the minimum requirements are:
Bactericidal activity (mandatory):
• EN 13727 (Phase 2/1) - temperature between 20-70°C, maximum time 60 minutes
• EN 14561 (Phase 2/2) - test on instruments, 60 minutes at 20°C
Yeasticidal activity (mandatory):
• EN 13624 (Phase 2/1)
• EN 14562 (Phase 2/2)
Additional standards (optional, depending on use):
• EN 13624 (Phase 2/1), EN 14562 (Phase 2/2) - fungicidal activity
• EN 14348 (Phase 2/1), EN 14563 (Phase 2/2) – tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1), EN 17111 (Phase 2/2) - virucidal activity against enveloped viruses/general virucidal activity
• EN 17126 (Phase 2/1 only) - sporicidal activity against C. difficile/general sporicidal activity
2.4. Surface disinfection
The standard distinguishes between disinfection without mechanical action (spraying) and with mechanical action (wiping).
Disinfection WITHOUT mechanical action:
Mandatory standards:
• EN 13727 (Phase 2/1) - bactericidal activity, temperature between 4-30°C
• EN 13624 (Phase 2/1) - yeasticidal activity, temperature between 4-30°C
• EN 17387 (Phase 2/2) - bactericidal/yeasticidal activity,
Contact times:
• Maximum 5 minutes for surfaces in contact with the patient or medical staff
• Maximum 60 minutes for other surfaces
Additional standards (optional):
• EN 13624 (Phase 2/1), EN 17387 (Phase 2/2) - fungicidal activity
• EN 14348 (Phase 2/1) - tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1), EN 16777 (Phase 2/2) - virucidal activity against enveloped viruses/virucidal activity with limited spectrum/general virucidal activity
• EN 17126 (Phase 2/1) - sporicidal activity against C. difficile/general sporicidal activity
Important note for products without mechanical action:
For products tested WITHOUT mechanical action, it must be clearly specified in the instructions for use that mechanical action (wiping) MUST NOT take place during the contact time (it is considered outside this time). The product must be left to act on the surface for the specified period before any wiping.
Disinfection WITH mechanical action:
Mandatory standards:
• EN 13727 (Phase 2/1), EN 16615 (Phase 2/2) - bactericidal activity
• EN 13624 (Phase 2/1), EN 16615 (Phase 2/2) - levuricidal activity
Contact times:
• Maximum 5 minutes for surfaces in contact with the patient or medical staff
• Maximum 60 minutes for other surfaces
• Minimum 1 minute for EN 16615 (4-field test)
Additional (optional) standards:
• EN 13624 (Phase 2/1) - fungicidal activity
• EN 14348 (Phase 2/1) - tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1) - virucidal activity against enveloped viruses/limited spectrum virucidal activity/virucidal activity
• EN 17126 (Phase 2/1) - sporicidal activity against C. difficile/sporicidal activity
2.5. Airborne disinfection of room surfaces (by nebulization)
Mandatory standard:
• EN 17272 (Phase 2/2) – bactericidal, yeasticidal, fungicidal, mycobactericidal, tuberculocidal, virucidal, sporicidal activity
2.6. Disinfection of textiles
For the disinfection of medical linens and textiles, the mandatory standards are:
• EN 13727 (Phase 2/1 - under dirty conditions), EN 16616 (Phase 2/2 - chemo-thermal disinfection in washing machines) – bactericidal activity
• EN 13624 (Phase 2/1 - under dirty conditions), EN 16616 (Phase 2/2 - chemo-thermal disinfection in washing machines) – yeasticidal activity
Additional standards (optional):
• EN 13624 (Phase 2/1, dirty conditions), EN 16616 (Phase 2/2) - fungicidal activity
• EN 14348 (Phase 2/1, dirty conditions), EN 16616 (Phase 2/2) - tuberculocidal/mycobactericidal activity
• EN 14476 (Phase 2/1, dirty conditions) - general virucidal activity
• EN 17126 (Phase 2/1) - sporicidal activity against C. difficile/general sporicidal activity
2.7. Water treatment for Legionella control
For the treatment of water systems against Legionella:
Mandatory standard:
• EN 13623 (Phase 2/1)
Testing conditions:
• Test organism: Legionella pneumophila subsp. pneumophila ATCC 33152
• Temperature: 30°C for cooling water, 20°C for water for general purposes
• Contact time:
– Fast-acting products: 1 hour at 20-30°C
– Slow-acting products: 15 hours at 30°C
• Logarithmic reduction: ≥ 4.0 lg
Additional permitted conditions:
• Other Legionella strains (e.g., Legionella pneumophila serogroup 1 Benidorm NCTC 12006, ATCC 43108)
• Additional contact times: 2h, 6h, 40h, 48h
In the next article in this series, you will read about the full spectrum of antimicrobial activity: from bacteria to spores, how to select the right level of protection, and exactly when each type of activity is necessary.
Informational document based on SR EN 14885:2022. This material is for educational purposes and does not replace consultation of the official standard.
Bibliography:
ASRO (2022). SR EN 14885:2022 – Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics.
Photo source:
Freepik
