BS EN 16616: 2022

Evaluation of microbicidal activity of decontamination process used in chemical-thermal textile disinfection

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Quick understanding of the test

BS EN 16616: 2022 - Evaluation of microbicidal activity of decontamination process used in chemical-thermal textile disinfection

To evaluate the microbicidal efficacy of chemical-thermal disinfection processes for treating contaminated textiles in medical and other critical environments.

Application

Applicable for products used for laundry disinfection in medical settings.
  • Sterilized fabric (carriers) are contaminated with test organisms in defibrinated sheep blood and then dried.
  • Contaminated carriers are subjected to disinfection in a washing machine at a specified temperature.
  • After the disinfection process,  carriers are transferred to tubes containing neutralizing solutions.
  • The surviving microorganisms in neutralizing extract  are enumerated, and the reduction rate is calculated.

Turnaround Time

It typically takes 2-5 weeks.
Results are evaluated by calculating the microbial log reduction on treated textiles compared to untreated controls.

Passing criteria

In the case of bactericidal, tuberculocidal, and Mycobactericidal activity, a product must achieve a log reduction of 7. In the case of yeasticidal and fungicidal activity, a product must achieve a log reduction of 6.

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Abstract

EN 16616 specifies a carrier test (phase 2, step 2)  that determines the microbicidal activity of disinfection processes used for the treatment of contaminated textile fabric. The EN 16616 procedure is carried out by using a carrier and washing machine to replicate the original conditions in which the disinfectant is intended to be used. 

EN 16616 is a standardised method used for validating the disinfection part of the textile laundry process. EN 16616 test method is mainly used in areas and situations where disinfection is medically indicated –

  • Hospitals, medical facilities and nursing homes
  • Schools and kindergartens 
  • Food processing plants, hotels and workwear of pharmaceutical industries, laboratories, etcetera

The assessment of textile disinfection is very crucial in these sectors in order to prevent transmission of infectious diseases and to maintain a safe and hygienic environment. 

EN 16616 Test Conditions & Requirement

The parameters specified by BS EN 16616 standard are as follows : 

 

Test conditions

Textile disinfection temperature < 60 °C

Textile disinfection temperature 60 °C

Test organism 

Escherichia coli (K12) (NCTC 10538) 


Enterococcus hirae (ATCC 10541)


Pseudomonas aeruginosa (ATCC 15442)


Staphylococcus aureus (ATCC 6538)

 

Candida albicans (ATCC 10231)                           

Enterococcus faecium  (ATCC 6057)

Additional test organism

 

Fungicidal activity

 

Mycobactericidal activity


Aspergillus brasiliensis (ATCC 16404)


Mycobacterium terrae (ATCC 15755 ) and Mycobacterium avium (ATCC15769™)

Temperature 

As recommended by the manufacturer and < 60 °C.

As recommended by the manufacturer and 60 °C.

Contact time

As recommended by the manufacturer.

As recommended by the manufacturer.

Interfering substance 

Sheep blood

Sheep blood

Passing criteria: Log reduction 

Bactericidal activity – 7 log reduction 


Yeasticidal activity – 6 log reduction 


Fungicidal activity – 6 log reduction 


Tuberculocidal activity – 7 log reduction


Mycobactericidal activity – 7 log reduction

7 log reduction

EN 16616 Test Method

  • Sterilised cotton fabrics of size 1 cm2 are used as carriers for testing.
  • Carriers are contaminated with inoculum mixture containing bacterial test suspension and defibrinated sheep blood. 
  • The carriers are dried and transferred into cotton towels. 
  • These cotton towels are then subjected to the disinfection process in the washing machine at the test temperature of < 60 °C or 60 °C.
  • After the disinfection, towels containing the carriers are taken out. 
  • Each carrier is removed from the cotton towel and shifted into a tube with neutralizer and glass beads. 
  • These tubes are then subjected to mild centrifugation in order to recover test microorganisms from the cotton carrier. 
  • The number of surviving test microorganisms are counted in each sample and the log reduction rate is calculated.

Importance of EN 16616 Test

The EN 16616 standard outlines a method of testing the decontamination process used for textile disinfection. It’s also a minimum requirement for assessing the microbicidal activity of a defined textile disinfection process. This test is applied to all areas and situations where high level of hygiene is particularly important, i.e. medical area, nursing homes, etcetera in order to provide a clean, safe and healthy environment for patients and workers.

Conclusion

At Microbe investigations, we provide antimicrobial testing services for products from prime industries and manufacturers (disinfectants, textiles, coatings and plastic) worldwide. Our specialised team of experts prioritises on delivering accurate, precise results on time at an affordable cost. 

MIS also conducts EN 16615 test method for evaluating antimicrobial activity of disinfectant wipes being used in the medical sector.

For further information regarding EN 16616 testing and other test methods, you can consult our experts.

Frequently Asked Questions

DR. Martinoz Scholtz

MIS Labs
1. What is EN 16616 test?

EN 16616 specifies a carrier test method to determine the microbicidal efficacy of a single product or product combination used for disinfection of contaminated textiles.

2. What are the products that can be tested with EN 16616 test?

EN 16616 test is applicable for products used for laundry disinfection in medical settings. This test involves a chemical thermal disinfection process to eliminate pathogenic microbes from clothes.

3. What is the turnaround time for EN 16616 test?

The EN 16616 test takes 2 – 5 weeks depending on the test organism. 

4. On how many microbial strains can your EN 16616 testing lab perform tests on?

At Microbe Investigations, we test for EN 16616 using the following microbial strains : E. coli K12 (NCTC 10538), E. hirae ( ATCC 10541), P. aeruginosa ( ATCC 15442), S. aureus  (ATCC 6538), C. albicans (ATCC 10231), A. brasiliensis (ATCC 16404), M. terrae (ATCC 15755) ,  M. avium (ATCC 15769) and E. faecium (ATCC 6057).

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