Frequently Asked Questions - Bluetree Mask Box
Here are some frequently asked questions that should tell you everything you need to know when it comes to our products.
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Frequently Asked Questions:
What standards do Obisk Type IIR Surgical Masks conform to?
The standards applied to Obisk Type IIR Surgical Masks are as follows: BS EN ISO 9001:2015, BS EN ISO 14971:2019, BS EN ISO 15223-1:2015, BS EN ISO 10993-1:2009, BS EN 14683:2019, BS EN 1041:2008+A1:2013
What are Type IIR Surgical Masks?
Type IIR Surgical Masks are medical devices that act to filter the expelled air/mucous/spit of their user to protect those around them from infection. The standard for Medical Face Masks is BS EN 14683:2019, there are 3 different types of masks in this standard, Type I, II and IIR. Type IIR Surgical Masks have a Bacterial Filtration Efficiency (BFE) of ≥ 98% and a Differential Pressure of <60 Pa/cm2. Unlike Type I and II masks Type IIR masks are splash resistant and have a Splash Resistance Pressure of ≥ 16.0 kPa. All Medical Face Masks have a Microbial Cleanliness of ≤ 30 cfu/g.
Type IIR Surgical Masks differ from other types of masks such as FFP masks (known elsewhere as N masks). Type IIR Surgical Masks are medical devices where as FFP masks are PPE. The basic difference between the two types of masks is that Surgical Masks protect those around the person wearing them from infection and FFP masks protect those wearing them from infection. As such, both types of masks conform to different British standards.
What are the technical specifications of Obisk Type IIR Surgical Masks?
In accordance with BS EN 14683:2019 Obisk Type IIR Surgical Masks the following technical specifications:
Bacterial Filtration Efficiency (BFE) ≥ 99%
Differential Pressure < 60 Pa/cm2
Splash resistance pressure ≥ 16.0 kPa
Microbial Cleanliness ≤ 30 cfu/g
What materials are Obisk Type IIR Surgical Masks composed of?
Obisk Type IIR Surgical Masks are made up of 5 components:
- Elasticated ear loops
- Aluminium wire nose bridge
- Hydrophobic nonwoven fabric
- Hydrophilic nonwoven fabric
- Meltblown nonwoven fabric
How do Obisk Type IIR Surgical Masks work?
Surgical masks work to filter the expelled air/spit/mucous of the wearer to protect those around them from infection. The meltblown nonwoven fabric is the ‘filter layer’ of Obisk Type IIR Surgical Masks, this fabric can filter ≥ 99% of bacteria being expelled by the wearer of the mask. Alongside this fabric, the hydrophobic nonwoven fabric is the ‘outer layer’ of Obisk Type IIR Surgical Masks, this fabric makes the mask splash resistant to protect the wearer from any biological splashes (blood or bodily fluids) they may experience during normal use.
In addition to this, the hydrophilic nonwoven fabric is the ‘inner layer’ of the masks, this fabric is entirely for the comfort of the wearer. It works by reducing the moisture within the mask, and it’s also extra soft, to make the mask more comfortable to wear. The elasticated ear loops and aluminium wire nose bridge of Obisk Type IIR Surgical Masks are designed to ensure the mask fits closely to the wearer’s face so that the masks are as efficient as possible.
Are there any harmful side effects of wearing Obisk Type IIR Surgical Masks?
If Obisk Type IIR Surgical Masks are worn correctly, there are no known side effects of their use. The hydrophobic nonwoven fabric in the masks is known to cause skin irritation if it comes into contact with the skin. This fabric is the blue outer material in the masks so it should not come into contact with the skin during normal use. All materials in Obisk Type IIR Surgical Masks are latex free.
Have Obisk Type IIR Surgical Masks been tested on animals?
No. Obisk Type IIR Masks have been tested in accordance with BS EN 14683:2019. This testing does not require the use of any animals as test subjects.
Can Obisk Type IIR Surgical Masks be disinfected and reused?
No. Obisk Type IIR Surgical Masks are intended as a single-use, disposable device. It is not recommended that the masks be reused in any way, even if they are disinfected beforehand. Reusing the masks may reduce their efficacy and the risk of infection will be greatly increased.
Are Obisk Type IIR Surgical Masks sterile?
No. Obisk Type IIR Surgical Masks are intended as non-sterile devices. They are not sterilised as part of the manufacturing process and are not intended to be sterilised by the end user before use. Obisk Type IIR Surgical Masks have a Microbial Cleanliness of ≤ 30 cfu/g in line with BS EN 14683:2019. As such, Obisk Type IIR Surgical Masks are not intended for use in sterile environments.