Understanding SR EN 14885:2022 in the medical field - Part III: Practical applications and compliance

Guide for medical professionals: European disinfection and antisepsis standards in the medical area

According to SR EN 1 4885:2022 - Part III: Practical applications and compliance

7. Practical criteria for product selection

7.1. Compliance verification

When selecting a disinfectant or antiseptic, verify that:

1.          The product is tested according to relevant standards for your specific application (e.g., EN 1500 for hygienic hand rub)

2.          BOTH testing stages are fulfilled (Phase 2/Step 1 AND Phase 2/Step 2)

3.          The activity spectrum meets your needs (bactericidal + yeasticidal minimum; virucidal or sporicidal if necessary)

4.          The testing conditions (clean/dirty) correspond to actual use conditions

5.          Contact time and temperature are practical and can be maintained in your clinical setting

7.2. Examples of clinical scenarios

Scenario 1: Disinfection of surfaces in a room occupied by a COVID-19 patient

•             Requirement: virucidal activity against enveloped viruses (minimum)

•             Standards: EN 13727 + EN 13624 + EN 14476 (Phase 2/1) + EN 17387 or EN 16615 (Phase 2/2)

•             Contact time: maximum 5 minutes for surfaces in contact with the patient

Scenario 2: Endoscope disinfection

•             Requirement: bactericidal, yeasticidal, tuberculocidal, virucidal activity

•             Standards: EN 13727 + EN 13624 + EN 14348 + EN 14476 (Phase 2/1)

•             Plus: EN 14561 + EN 14562 + EN 14563 + EN 17111 (Phase 2/2)

Scenario 3: C. difficile outbreak on the ward

•             Requirement: sporicidal activity against C. difficile

•             Standards: EN 17126 (Phase 2/1) in addition to standard bactericidal/yeasticidal activities

•             Contact time: maximum 15 minutes for surfaces in contact with the patient

Scenario 4: Prevention of viral gastroenteritis outbreaks (Norovirus)

•             Required: limited spectrum virucidal activity (minimum)

•             Standards: EN 13727 + EN 13624 + EN 14476 with Adenovirus and Murine norovirus (Phase 2/1) + EN 16777 or EN 17387 (Phase 2/2)

•             Contact time: according to the manufacturer's recommendations, but no more than 5 minutes for surfaces in contact with the patient

Scenario 5: Legionella control in the hospital water system

•             Required: activity against Legionella

•             Standard: EN 13623 (Phase 2/1)

•             Product type:

–            Rapid action: 1 hour at 20-30°C

–            Slow action: 15 hours at 30°C

8. Special aspects and advanced considerations

8.1. Chemo-thermal disinfection

For chemo-thermal processes (temperature > 40°C), the standard stipulates:

•             At temperatures ≥ 40°C, Enterococcus faecium ATCC 6057 is used as a thermo-resistant test organism (instead of other bacteria)

•             For virucidal activity at temperatures ≥ 40°C, Murine parvovirus is used (instead of other viruses)

•             Applicable for: instrument disinfection, textile disinfection

8.2. Automated Airborne Room Disinfection

For automated disinfection processes (fogging, vaporizing):

•             Standard: EN 17272 (Phase 2/2)

•             Process time: maximum 15 hours (can be extended up to 48 hours for special conditions)

•             Can be tested: bactericidal, fungicidal, levuricidal, virucidal, sporicidal, mycobactericidal activity

•             Applicable for: hospital rooms, operating rooms, isolation areas

8.3. Dual-effect products: cleaning and disinfection

For products that combine cleaning with disinfection (pre-cleaning products):

•             Can use EN 17111 (Phase 2/2) for testing virucidal activity against enveloped viruses

•             Are tested under conditions that simulate simultaneous use for cleaning and disinfection

9. Mandatory information on the label

9.1 According to SR EN 14885:2022 (minimum requirements for efficacy claims)

According to clause 7 of SR EN 14885:2022, the manufacturer must provide at least the following information:

a) type and/or purpose of the product (e.g., hygienic hand rub disinfectant, chemical disinfectant for surfaces, etc.);

b) area and field of application:

·           area of application (medical, veterinary, food/industrial/domestic/institutional);

·           field of application (hygienic hand rub, hard surfaces, etc.);

c) spectrum of activity (e.g., bactericidal, fungicidal, virucidal, etc.); "microbiocidal activity" cannot be claimed generically; furthermore, static-type activities ("bacteriostatic", "fungistatic", etc.) cannot be claimed;

d) reference of the European standards against which compliance is claimed (e.g., bactericidal according to EN 13727, fungicidal according to EN 13624);

e) recommended application method(s), including: usage concentration(s), product diluent(s), volume to be applied, application procedure, contact time(s), application temperature(s); products tested without mechanical action must explicitly state that mechanical action (e.g., wiping) should not be performed during the contact time;

f) soiling conditions (clean or dirty); specify whether pre-cleaning is required before disinfection.

9.2 Additional requirements according to Regulation (EU) No 528/2012, Art. 69 (mandatory for authorized biocidal products)

In addition to the information provided in point 9.1, for authorized biocidal products, the label must clearly and indelibly contain the following additional information:

a) identity of each active substance and its concentration in metric units; if the product contains nanomaterials, they must be explicitly mentioned followed by the word "(nano)";

b) authorization number allocated to the product by the competent authority or the Commission;

c) name and address of the authorization holder;

d) type of preparation;

e) adverse side effects (direct or indirect) and first aid instructions;

f) instructions for safe disposal of the product and packaging, including the prohibition of reusing the packaging, if applicable;

g) batch number and expiry date under normal storage conditions;

h) safety intervals to be observed between applications or between application and re-entry of persons/animals into the treated area, including ventilation duration and necessary decontamination measures;

i) information on environmental hazards, particularly the protection of non-target organisms and the prevention of water contamination, if applicable;

j) classification, hazard (H) and precautionary (P) phrases according to Regulation (EC) No 1272/2008 (CLP).

Note: The label must not contain claims such as "low-risk biocidal product", "non-toxic", "harmless", "natural", "eco-friendly", or "animal-friendly".

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. The product must be left to act on the surface for the specified period before any wiping.

10. Validation and quality control of testing

10.1. Requirements for laboratories

Laboratories performing the tests must meet the following requirements:

•             Compliance with an appropriate quality assurance system (e.g., EN ISO/IEC 17025)

•             Regular participation in proficiency testing

10.2. Precision of test methods

To improve the precision of the results, it is recommended:

•             Test repetitions: especially with the organism least susceptible to the product

•             Testing in multiple laboratories: when results are critical for important claims

•             Use of internal standards: for monitoring the consistency of results over time

The EN 14885:2022 standard provides a robust and standardized framework for the evaluation of disinfectants and antiseptics in the medical area. Understanding these requirements allows you to:

✓ Select the right products for each specific clinical application

✓ Verify that products have been appropriately tested and meet the relevant standards

✓ Use products according to scientifically validated recommendations

✓ Ensure the safety of patients and medical staff

✓ Comply with European and national regulatory requirements

Final recommendation:

Periodically evaluate the products used in your institution to ensure that they meet the latest standards and infection prevention requirements. The EN 14885 standard is updated periodically to reflect the latest scientific and technical developments in the field of disinfection and antisepsis

Informative document based on SR EN 14885:2022. This material is for educational purposes and does not replace consultation of the official standard. The complete SR EN 14885:2022 standard can be purchased from ASRO (Romanian Standards Association)

Bibliography:

ASRO (2022). SR EN 14885:2022 – Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics.

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