Virucidal Disinfection to EN 14476 on Healthcare Surfaces

This protocol describes how to disinfect high-contact surfaces in healthcare, geriatric and physiotherapy centres with disinfectants whose virucidal activity has been tested according to standard EN 14476. There is no universal "1:10 and 5 minutes" dose: each product has its own dose, contact time, test viruses and conditions (clean or dirty) set out in its technical data sheet and in its registration as a biocide under Regulation (EU) No 528/2012. The figures for Instaquim products tested to EN 14476 are reproduced here exactly as given.

Contact time: 5 minutes with InstaBact® DS undiluted, with InstaBact® DS Plus undiluted and with InstaBact® 3000 at 50 %; 15 minutes with Bacter and Bacter 100 diluted at 5 %

Applicable sectors: Hospitals, clinics, geriatric and day-care centres, physiotherapy facilities and outpatient clinics; products with an "HA" registration also cover the food industry

Recommended frequency: According to the centre's cleaning and disinfection plan, with reinforcement of high-contact areas during outbreaks

Materials required

Ready-to-use disinfectant with EN 14476: InstaBact® DS (applied undiluted, at least 5 min) or InstaBact® DS Plus (sprayed undiluted from around 40 cm, 5 min)
Concentrated disinfectant with EN 14476: InstaBact® 3000 (virucidal dose of 50 %, 5 min), Bacter or Bacter 100 (virucidal dose of 50 g/l, i.e. 5 %, 15 min)
Neutral detergent for prior cleaning, for example eqo Multiusos diluted at 5 to 10 g/l
Graduated and labelled container for preparing the dilutions
Sprayer, clean cloths or wipes and single-use paper
Clean water for rinsing the products that require it
Protective gloves and goggles as per the safety data sheet of the chosen product
Disinfection record sheet

Step-by-step procedure

Prior cleaning of the surface: Remove objects and debris and clean with a neutral detergent such as eqo Multiusos at 5 to 10 g/l, rinsing and leaving the surface free of visible organic matter. Mandatory with products tested under clean conditions (InstaBact® 3000, InstaBact® DS Plus, Bacter and Bacter 100). InstaBact® DS cleans and disinfects in a single operation and is tested under dirty conditions, so it tolerates residual soil better.
Choice of product and dose: For rapid disinfection of furniture, equipment and contact points, InstaBact® DS or InstaBact® DS Plus undiluted. For large surfaces, floors and walls with dilution, InstaBact® 3000 at 50 %, or Bacter and Bacter 100 at 5 % (50 g/l). Do not mix products or change the dose given in the data sheet.
Preparing the dilution (concentrates only): InstaBact® 3000 is applied diluted in water at a dose of 50 % for virucidal effect; Bacter and Bacter 100 are applied diluted in water at a dose of 50 g/l (5 %). Label the container with product, dose, date and person responsible. InstaBact® DS allows a 5-10 % dilution only for the daily maintenance of less critical surfaces such as floors or tiles, not as a virucide.
Personal protective equipment: Put on protective gloves and goggles in accordance with the safety data sheet of each product. InstaBact® DS Plus contains 65 % ethanol: do not spray on hot surfaces or near flames, and ventilate the area. Bacter (pH 11.5 ± 0.5) and Bacter 100 (pH 12.0 ± 0.5) are alkaline: take care with skin and eyes when diluting.
Application: InstaBact® DS is applied undiluted by spraying, immersion or wiping with a cloth. InstaBact® DS Plus is sprayed undiluted onto clean surfaces from a distance of around 40 cm to form a uniform film. Dilutions of InstaBact® 3000, Bacter and Bacter 100 are applied with a sprayer, cloth or mop until the whole surface is covered. Treat the high-contact points first: bed rails, bedside tables, door handles, switches and examination couches.
Contact time: Keep the surface wet for the time given in its data sheet: at least 5 min with InstaBact® DS; 5 min with InstaBact® DS Plus for bactericidal and virucidal activity (15 min if fungicidal activity is also required); 5 min with InstaBact® 3000 at 50 %; 15 min with Bacter and Bacter 100 at 5 %. Reapply if the surface dries sooner; time from the end of application.
Product removal or rinsing: With InstaBact® DS, wipe with a scouring pad, cloth or paper to remove any remaining soil or contamination and repeat if necessary. With InstaBact® DS Plus, wipe with single-use paper until fully evaporated. With InstaBact® 3000, Bacter and Bacter 100, rinse with plenty of water in all cases.
Record and close-out: Record product, biocide registration number, batch, dose, time of application, contact time observed, areas treated and operator. Store leftover dilutions in closed, labelled containers, wash hands and keep the record in accordance with the centre's management system.

Verification and control

Documentary check: the product has an EN 14476 test in its data sheet and a valid biocide registration, and the dose and time applied match those in the data sheet. Visual check: the surface has remained wet for the full time and the product has been removed or rinsed as each data sheet indicates. Actual scope of each test: InstaBact® DS and Bacter Clor comply with EN 14476 under dirty conditions; InstaBact® 3000, Bacter and Bacter 100 comply under clean conditions. The declared test viruses are Adenovirus type 5 and Murine norovirus for InstaBact® DS, InstaBact® 3000 and Bacter 100, and Poliovirus type 1, Adenovirus type 5 and Murine norovirus for Bacter and Bacter Clor. If the centre carries out microbiological surface controls, the criteria are set by its hygiene plan; this protocol does not establish numerical limits.

Safety and PPE

Consult the safety data sheet of each product before use and follow its H and P statements; all the products mentioned are for application by professional personnel
Protective gloves and goggles while preparing dilutions of InstaBact® 3000, Bacter and Bacter 100 and during application
InstaBact® DS Plus: do not spray on hot surfaces or near flames
Do not ingest any product; in case of eye contact, wash with plenty of water and consult the safety data sheet

Recommended Instaquim products

Ready to use with EN 14476: InstaBact® DS (registration 20-20/40-10631 and 20-20/40-10631-HA) is an alcohol-free, chlorine-free disinfectant cleaner that is applied undiluted and left to act for at least 5 min; it complies with EN 14476 under dirty conditions for Adenovirus type 5 and Murine norovirus. InstaBact® DS Plus (registration 25-20/40/90-12659 and 25-20/40/90-12659-HA) is a 65 % ethanol-based disinfectant for spraying from around 40 cm onto clean surfaces, with 5 min of contact for bactericidal and virucidal activity.

Concentrates with EN 14476: InstaBact® 3000 (registration 22-20/40-11678 and 22-20/40-11678-HA), a quaternary ammonium compound with pH 7 ± 1, with a bactericidal dose of 2 % for 5 min and a virucidal dose of 50 % for 5 min. Bacter (registration 22-20/90-04313 and 19-20/90-04313 HA), a triple-action disinfectant detergent, with a bactericidal dose of 40 g/l (4 %) for 5 min and a virucidal dose of 50 g/l (5 %) for 15 min. Bacter 100 (registration 19-20-04311-HA), an alcohol-free alkylamine, with a bactericidal dose of 10 g/l (1 %) for 5 min and a virucidal dose of 50 g/l (5 %) for 15 min.

Kitchen and food areas of the centre: Bacter Clor (registration 18-20-06676-HA), a foaming chlorinated alkaline bactericidal detergent, tested to EN 14476 under dirty conditions for Poliovirus type 1, Adenovirus type 5 and Murine norovirus; it is used at 2 to 5 % with 5-15 minutes of contact and rinsing with pressurised water, within the framework of Regulation (EC) No 852/2004 and the kitchen's HACCP plan.

Related products that are not for surfaces: Sanitex disinfects linen in professional laundering at 4 g per kg of dry linen in the penultimate rinse; Bacter 200 is a biocide for legionella control in cooling towers and evaporative condensers.

Applicable regulations: EN 14476 (virucidal activity of chemical disinfectants), UNE-EN 13697 (bactericidal and fungicidal activity on surfaces), Regulation (EU) No 528/2012 (biocides), Regulation (EC) No 1272/2008 CLP (classification and labelling) and Regulation (EC) No 852/2004 with HACCP for food-handling areas.

Frequently asked questions

What does it mean that a disinfectant "complies with EN 14476"?

EN 14476 is the European standard for testing the virucidal activity of chemical disinfectants. A product complies with it for the test viruses, dose, time and conditions (clean or dirty) stated in its technical data sheet, not generically.

Can I use a 1:10 dilution with 5 minutes of contact for all virucides?

No. Each data sheet sets its own virucidal dose: InstaBact® 3000 at 50 % for 5 min; Bacter and Bacter 100 at 50 g/l (5 %) for 15 min; InstaBact® DS and InstaBact® DS Plus undiluted for 5 min. A 10 % dilution with 5 min corresponds to none of them.

What is the difference between "clean conditions" and "dirty conditions"?

They indicate the organic load present in the test. InstaBact® DS and Bacter Clor comply with EN 14476 under dirty conditions; InstaBact® 3000, InstaBact® DS Plus, Bacter and Bacter 100 comply under clean conditions, so with these products prior cleaning of the surface is essential.

Which product should I choose for surfaces with suspected norovirus or rotavirus?

InstaBact® DS is the one whose data sheet describes the broadest scope: it complies with EN 14476 under dirty conditions for Adenovirus type 5 and Murine norovirus, so it is considered active against Rotavirus and against the enveloped viruses cited in the standard (Coronavirus, Influenza A H1N1, Hepatitis B, C and D, etc.). It is applied undiluted and left to act for at least 5 min.

Is Sanitex suitable for disinfecting surfaces?

No. Sanitex is a quaternary ammonium disinfectant for linen in professional laundering: 4 g per kg of dry linen in the penultimate rinse, with a minimum time of 5 min. Its data sheet does not cite EN 14476, so it must not be presented as a surface virucide.

And Bacter 200?

It is not a surface product either. Bacter 200 is a biocide for legionella treatment in cooling towers and evaporative condensers (UNE-EN 13623 test for 60 minutes at 30 ºC; starting dose of 0.2 to 0.4 % every 7 days), within the Legionella control programme required by Royal Decree 487/2022. It is not applied in this protocol.

Is rinsing required after disinfection?

It depends on the product. InstaBact® 3000, Bacter and Bacter 100 are rinsed with plenty of water in all cases. With InstaBact® DS, a scouring pad, cloth or paper is used to remove any remaining contamination, and with InstaBact® DS Plus single-use paper is used until fully evaporated.

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