Disclaimer

The results specified in this report are from a proof of concept screening test carried
out on one of FROLIC studio’s Decontamination Boxes, by HygCen Laboratory. The
screening tests were done on Type iiR (surgical) masks, and it is possible that
alternative masks made of different materials may prove to have different results
whilst using the same reprocessing activity. These tests were carried out on the
original prototype Decontamination Box and the results are therefore not applicable if
the UV source is altered in any way.

Regarding the above, no liability can be taken by HygCen Germany GmbH or FROLIC
studio in the event of any claim.
FROLIC studio
Lauriergracht 116A
1016 RR, Amsterdam

29.04.2020

TESTREPORT
Identification of the test
laboratory: SN 29524

Date of order: 2020-04-03

Test number 2020-1060

Delivery date: 2020-04-03

Products: UV-Disinfection Box

Customer: FROLIC studio

Test time period: 2020-04-08 until 2020-04-15 (Disinfection efficacy against

bacteria, screening test)

Test methods: Contamination of products with test soil to test the disinfection
efficiency and the recovery of the test soil on the basis of ISO
15883-5, SOP 19-002

Processing of health care products — Information to be

provided by the medical device manufacturer for the processing
of medical devices EN ISO 17664:2017;
SOP 19-001

Guideline of the Robert-Koch-Institute „Requirements according

the hygiene of the reprocessing of medical devices“

SN 29524a page 1 of 7
Projectcontent

Screening-test for the decontamination efficacy of a UV process using masks.

Fig.1: UV disinfection box

SN 29524a page 2 of 7
Fig. 2: Face masks type II R

SN 29524a page 3 of 7
Efficacy against bacteria (sceening test)

Contamination of test samples with test soil

Date of 2020-04-08
contamination:

Test samples: face masks type IIR

Test germs: Staphylococcus aureus ATCC 6538

Organic burden: clean conditions

Preparation of the
test soil 10% of a 0.3% serum albumin stock solution was added to a
germ suspension with a germ concentration of approx. 108
colony-forming units (CFU), resulting in a concentration of
0.03% serum albumin in the test suspension. 100 µl of this
suspension were used to contaminate the test specimens.

Contamination of the test samples:

Kontaminations 100 µl test soil were spread over an area of 4 cm² of the
methode face mask

Drying of the Up to the optical dryness of the test specimens1h at 22 ± 2

test soil: °C under Laminar Air Flow at 22 + 2 oC, rLF 36 %

Test of the effectiveness of UV disinfection

Application of the test Test specimen fixed on clambs

samples:

Disinfection procedure: UV-disinfektion

Holding time: 6 minutes

12 minutes
18 minutes

Conditions: 22 + 2 oC, 30 – 50 % rH

Positive controls: The colony forming units (cfu) of a contaminated, but not
exposed sample were determined.

SN 29524a page 4 of 7
Elution of the reprocessed test samples – disinfection

Elution of the test samples, soiled with clean conditions and the test germ S.
aureus (disinfection)

Date of elution: 2020-04-08

Elution solution: TSB (Tryptone Soya Broth)

Elution volume: 10 ml

Elution of the test samples

Test samples: Face masks

Description of the elution: The sample was eluted in 10 ml elution solution by

shaking on a rotatory shaker at 300 rpm for 10 min
in a plastic container. Glass beads were applied for
a better recovery of the test soil.

Cultivation of the test samples

Positive controls: With dilution solution (0.1% tryptone and 0.85%

sodiumchloride) dilutions were prepared and spread
on TSA (trypticase soya agar).

Test samples: 1.0 and 0.1ml of the eluate was spread on TSA.
Subcultivation of the eluates after 3 and 7 days on
TSA.

Incubation: Cultivation on TSA 7d at 36 ± 1°C

Incubation of the eluate 7d at 36 ± 1°C
Subcultivation of the eluate 24h on TSA at 36 ± 1°C

Calculation: Calculation of the reduction factor (RF)

RF=lg cfu/positive control – lg cfu test piece

SN 29524a page 5 of 7
Results of testing UV disinfection performance

Results of the positive controls

Extent of S aureus recovery
Volumen TSB
Test samples KBE/PK KBE lg/PK
[ml]
Sample face masks 10 1.34x107 7.13

Results of the test samples after disinfection

Extent of S. aureus recovery
Volumen CSL Enrichment*
Sample no. Test product CFU/TS lg/TS RF
[ml]
TS-6 min 10 0.00 - 0.00 >7.13
TS-12 min face mask 10 0.00 - 0.00 >7.13
type IIR
TS-18 min 10 0.00 - 0.00 >7.13
Legend:
**) = Subcultivation on TSA after 7 days
CFU = Colony forming units
TS = Test sample
TSA = Tryptone soya agar
TSL = Tryptone soya solution
+ = Clouding as a result of growth of germs and controlled by subculture (enrichment)
- = No growth of germs
RF = Reduction factor = (initial contamination [lg] – residual contamination [lg]

SN 29524a page 6 of 7
Conclusion

With the accomplished tests could be shown, that a quantifiable disinfection of a face
mask under use of the UV-disinfection Box is possible.

The results of the disinfection show, that the required reduction of the test organism
by ≥ 5 lg steps could be achieved with the procedures performed within 6 minutes
exposure time.

Archiving: The raw data with respect to this test and a copy of the
report will be stored in the archive of HygCen.

Information: The test results exclusively refer to the samples described above.
Account of extracts of this test report is only possible by written
approval from HygCen.

Prof. Dr. med. H.-P. Werner Dr. rer. nat. O. Riebe

Manager of scientific-technical affairs Division Manager
Medical Devices

SN 29524a page 7 of 7