Regarding the establishment of the anti-burn «Fenix-MS» bed conformity with the requirements of quality and safety standards
The standards that anti-burn beds must meet are given. The design of the domestically produced anti-burn «Phoenix-MS» bed, which has improved design and technological indicators, is briefly described. The main test results of this bed, obtained in the process of independent conformity assessment, are presented. Their analysis showed that the product meets quality standards and ensures the safety of patients and medical personnel during its operation in medical institutions. It is noted that the manufacturer needs to carry out a more complete clinical evaluation of the product, taking into account the strengthening of this requirement in the new EU Regulation 2017/745 on medical devices.
Authors
- Oleksandr Kuzmenko (ORCID: https://orcid.org/0000-0002-2711-3027)
- Anatolii Starunskyi (ORCID: https://orcid.org/0009-0005-6632-7967)
- Salekh Abdulin
- Mykhailo Semenenko
Institutions
- State Enterprise «All-Ukrainian State Research and Production Center for Standardization, Metrology, Certification and Consumers Rights Protection»
Publication Details
- Journal
- Measurements infrastructure
- Published
- 2024-09-01
- DOI
- https://doi.org/10.33955/v8(2024)-055
- Primary Topic
- Healthcare Systems and Public Health
- Type
- article
- Field-Weighted Citation Impact
- 0.00