Toxicological and hygiene assessment of modern respiratory protection measures against respiratory infections

  • Authors: M.G. Prodanchuk, T.F. Kharchenko, O.O. Bobyliova, A.A. Kalashnikov, O.A. Kharchenko, S.V. Snoz
  • UDC: 615.46+613.63
  • DOI: 10.33273/2663-9726-2023-58-1-45-55
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"L.I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety, Ministry of Health, Ukraine" (State Enterprise), Kyiv, Ukraine


Abstract. One of the leading places among medical products in terms of application is occupied by surgical and protective, disposable masks, designed for protection and prevention of diseases that are transmitted by air.

Aim. Conduct an analysis of samples of protective and surgical masks to determine the possibility of their use as intended.

Materials and Мethods. Examination of medical and surgical masks of various manufacturers in accordance with the requirements of the Technical Regulations on medical products (Cabinet Resolution No. 753 dated 02.10.2013).

Results. Modern methodological approaches to assessing the degree of potential risk of medical products are based on the study of toxicological characteristics and sanitary-chemical indicators in accordance with the requirements of DSTU ISO 10993-1:2015, namely: determination of the spectrum of potential biological risk factors (cytotoxicity, skin-irritating and sensitizing effects), bactericidal filtration; determination of the qualitative and quantitative composition of chemicals (phenol, formaldehyde, acetaldehyde) in accordance with the requirements of DSTU EN ISO 10993-12:2015 and DSTU EN ISO 10993-13:2015; determination of breathability, durability against splashes, in accordance with the requirements (DSTU EN 14683:2014 "Surgical masks. Requirements and test methods"). The specified indicators make it possible to determine the possibilities of using medical products ‒ medical masks, are mandatory and are measured by the institutions of the Derzhspozhivstandard of Ukraine.

Conclusions. Modern methods of sanitary and chemical research make it possible to study the processes of migration of components and degradation products from the materials of medical masks into simulated environments, to identify the composition of migrating chemical compounds, to study the degradation products of polymers, and to determine the scope of further toxicological studies.

Keywords: biological safety, means of individual protection of respiratory organs, surgical and protective masks.



1. World Health Organization. Mask use in the context of COVID-19: interim guidance, 1 December 2020. World Health Organization. 2020. Electronic resource. URL:

2. Kang SY, Chung BY, Kim JC, Park CW, Kim HO. Clinical manifestations and patch test results for facial dermatitis associated with disposable face mask use during the COVID-19 outbreak: A case-control study. J Am Acad Dermatol. 2021 Sep;85(3):719-721. doi: 10.1016/j.jaad.2021.06.026. Epub 2021 Jun 14.

3. Xie Z, Yang YX, Zhang H. Mask-induced contact dermatitis in handling COVID-19 outbreak. Contact Dermatitis. 2020 Aug;83(2):166-167. doi: 10.1111/cod.13599.

4. Aerts O., Dendooven E., Foubert K., Stappers S.,Ulicki M., Lambert J. Surgical mask dermatitis caused by formaldehyde (releasers) during the COVID-19 pandemic. Contact Dermatitis. 2020 Aug;83(2):172-173. doi:10.1111/cod.13626.

5. Donovan J, Skotnicki-Grant S. Allergic contact dermatitis from formaldehyde textile resins in surgical uniforms and nonwoven textile masks. Dermatitis. 2007;18:40-44.

6. Raval M., Sangan H. Certain Face Masks Contain Toxic Chemicals, Inhalation of Which has the Potential to Affect the Upper Respiratory System/Journal of Tropical Disease and Public Health. J Trop Dis. 2012. Vol.9 Iss.7 No: 295.

7. DSTU EN ISO 10993-1:2015 Biological evaluation of medical devices. Part 1. Assessment and testing as part of the risk management process (EN ISO 10993-1:2009/AC:2010, IDT). Amendment No. 1:2015.

8. DSTU EN 14126:2008 Protective clothing. Protection against infectious agents. Performance requirements and test methods (EN 14126:2003, IDT)

9. National standard of Ukraine DSTU EN ISO 13688:2016 "Protective clothing. General requirements".

10. DSTU EN 149:2017 Personal protective equipment for respiratory organs. Filtering half-masks for protection against aerosols. Requirements, testing, marking (EN 149:2001+A1:2009, IDT).

11.DSTU EN 14683:2014 Surgical masks. Requirements and test methods (EN 14683:2005, IDT).

12. DSTU EN ISO 10993-12:2015 Biological evaluation of medical devices. Part 12. Sampling and reference materials (EN ISO 10993-12:2012, IDT; ISO 10993-12:2012, IDT).

13. DSTU EN ISO 10993-13:2015 Biological evaluation of medical devices. Part 13. Qualitative and quantitative analysis of degradation products of polymeric medical devices (EN ISO 10993-13:2010, IDT; ISO 10993-13:2010, IDT).

14. DSTU EN ISO 10993-9:2015 Biological evaluation of medical devices. Part 9. Basic principles of qualitative and quantitative analysis of potential degradation products (EN ISO 10993-9:2009, IDT; ISO 10993-9:2009, IDT)

15. DSTU EN ISO 10993-5:2015 Biological evaluation of medical devices. Part 5. In vitro cytotoxicity test (EN ISO 10993-5:2009, IDT; ISO 10993-5:2009, IDT).

16. DSTU ISO 10993-10:2004 Biological evaluation of medical devices. Part 10. Irritation and sensitization tests (ISO 10993-10:1995, IDT).

17. Technical regulation on medical devices (Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 753). Electronic resource. URL:

18. Technical regulation on medical devices for in vitro laboratory diagnostics (Decree of the Cabinet of Ministers of Ukraine dated July 16, 2008 No. 641). Electronic resource. URL:

19. State Pharmacopoeia of Ukraine / State enterprise "Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicinal Products". 2nd edition. Addendum 5. Kharkiv: State Enterprise "Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products", 2021. 424 p.

20. On the approval of Methodological instructions "Sterility control of medical products" (МВ-1-2004) (Order of the Ministry of Health of Ukraine (State Service of Medicines and Medical Products) dated 07.12.2004 N 322/1). Electronic resource. URL:

21. Lebedeva E.V., Konstantinova Y.B., Galatenko N.A. etc. Methodological guidelines "Toxicological-hygienic and preclinical studies of polymer materials and products based on them for medical purposes", K.: Nauk. opinion, 2009. 90 p.


Стаття надійшла до редакції 03.04.2023 р.

The article received on April, 3rd, 2023