The Covid-19 emergency brought a renewed awareness of the strategic importance of devices like masks, coats, and other protective clothes as well as of their proper certifications. Tests performed with wrong procedures or materials can bring to the commercialization of unsafe products.
The massive increase of the demand of medical devices (MD) and individual protection devices (IPD) brought to a significant enhancement of certification / verification requests. Among these devices, surgical masks must guarantee the protection against blood splashes. The synthetic blood designed by ReActive – Powder Technology is a safe, eco-friendly, ready-to-use, and verified product developed for this reason. This product has been designed to reduce as much as possible the time taken by splash tests.
The synthetic blood from ReActive – Powder Technology exists in three versions: the surgical mask variant (SBM) compliant with the ISO 22609:2004 standard, the surgical mask variant (SBM-F) compliant with the ASTM F1862/F1862M standard and the clothes variant (SBC) compliant with the BS ISO 16603:2004 standard. Every batch of SBM, SBM-F and SBC is tested before the packaging to certify its compliance with the required standards.
Synthetic Blood for Masks (SBM)
ISO 22609:2004
The synthetic blood (SBM) developed by ReActive – Powder Technology, currently under patenting, has been studied to execute the splash test requested by the BS EN 14683:2019 standard.
The splash test, described in details in the standard ISO 22609:2004, is used to verify the resistance of TYPE IIR surgical masks to blood and it cannot be executed simply using a colored liquid. On the contrary, the synthetic blood must feature well defined characteristics like a surface tension of 42.0 ± 2.0 mN/m (following the ISO 304 standard). The use of improper liquids could bring to wrong results with the consequent commercialization of unsafe devices. The synthetic blood of ReActive – Powder Technology has been designed to fully guarantee the ISO 22609:2004 requirements.
The SBM is designed to reduce as much as possible the time necessary to execute the splash test: it is supplied ready for use and it can be directly employed. The customer can then focus the attention on the test execution looking directly at the ISO 22609:2004 standard, thus saving time and money while granting a safe product. The SBM is available in the 500 ml and 1000 ml format and it can be shipped in every EU country.
SBM Characteristics (ISO 22609:2004)
Surface tension, σ | 42.0 ± 2.0 mN/m |
|---|---|
Density, ρ | 1.005 ± 0.002 g/cm² |
Synthetic Blood for Masks (SBM)
Bottle format: 250 ml - 500 ml - 1000 ml
Synthetic Blood for Masks (SBM-F)
ASTM F1862/F1862M
The synthetic blood (SBM) developed by ReActive – Powder Technology, currently under patenting, has been studied to execute the splash test requested by the ASTM F2100 standard.
The splash test, described in details in the standard ASTM F1862/F1862M, is used to verify the resistance surgical masks to blood penetration. Agains the european rules, the ASTM standard requires that all the surgical masks will resist to blood splashes assuring performance depending on the protection level of the mask (1, 2 or 3). In order to be certified, a mask must resist to the penetration of synthetic blood at different fluid velocities (450 cm/s for the Level1 protection , 550 cm/s for the Level2 protection, and 635 cm/s for the Level3 protection, corresponding to a blood pressure of 80 mmHg, 120 mmHg e 160 mmHg, respectively). The test can’t be executed using a colored liquid. On the contrary, the synthetic blood must feature well defined characteristics like a surface tension of 40.0 ± 5.0 mN/m (measured with the Du Noüy following the ASTM D1331 procedure). The use of improper liquids could bring to wrong results with the consequent commercialization of unsafe devices. The synthetic blood of ReActive – Powder Technology has been designed to fully guarantee ASTM F1862/F1862M requirements.
The SBM-F is designed to reduce as much as possible the time necessary to execute the splash test: it is supplied ready for use and it can be directly employed. The customer can then focus the attention on the test execution looking directly at the ASTM F1862/F1862M standard, thus saving time and money while granting a safe product. The SBM is available in the 500 ml and 1000 ml format and it can be shipped in every EU country.
SBM-F Characteristics (ASTM F1862/F1862M)
Surface tension, σ | 40.0 ± 5.0 dyn/cm |
|---|---|
Density, ρ | 1.005 ± 0.010 g/cm³ |