Remote Monitored Systems PLC EN14683 Certification, Commissioning Update (6403M)
January 22 2021 - 06:56AM
UK Regulatory
TIDMRMS
RNS Number : 6403M
Remote Monitored Systems PLC
22 January 2021
22 January 2021
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Remote Monitored Systems plc ("RMS" or the "Company")
EN14683 Certification Successful
Update on Commissioning
Remote Monitored Systems plc ("RMS" or the "Company") announces
that further to the announcement on 18 January 2021, Pharm 2 Farm
Ltd ("P2F") has today received the report from Eurofins confirming
that the P2F mask has now been certified as meeting the EN14683
standard having passed the biocompatibility test. The EN14683
standard comes on top of the ISO18184 certificate announced in
November 2020 and, once in production, the mask can now be sold in
the UK and Europe as a viricidal Type IIR mask.
To achieve the EN14683 standard, the mask had to pass five
tests, as follows:
Bacterial Filtration Efficiency (BFE): this tests the filtration
capacity of the mask. The P2F product achieved a 98.77%; higher
than the 98% required and close to the 99% needed for FFP3
respirator.
Differential Pressure: this tests the breathability of the mask.
The maximum limit to obtain Type IIR is <60pa/cm(2) . The P2F
mask achieved 46.4pa/cm(2) which provides a good balance of
breathability and BFE.
Splash resistance: this tests the resistance of the mask to
penetration by blood fluid at 16kPa. It is the only required for
Type IIR (differentiating it from Type II) as this type of mask can
be used in a surgical setting. The key to passing the test is to
have a hydrophobic outer layer on the mask. 100% of the masks in
P2F sample passed this test compared to the minimum 90% pass rate
requirement.
Microbiological cleanliness: this measures the quantity of
microorganisms on the mask, effectively, checking the cleanliness
of the manufacturing environment. The P2F masks passed, coming in
below the maximum permitted measure of 30 cfu/g (Note: CFU is a
microbiological measure for the number of viable cells in a
sample).
Biocompatibility test: this tests the reaction to human skin -
cytotoxicity, irritation and sensitization. The tests which
included a biological evaluation and in-vitro cytotoxicity were
performed to evaluate the effects of limited (less than 24 hours)
and cumulative prolonged use of the mask (from 24hrs to 30 days).
The P2F mask performed very well against the controls in all cases
and hence are considered to be not cytotoxic and not
irritative.
Commissioning of the machine at BioCity, Nottingham, commenced
this week but is taking longer than anticipated, as parts have been
delayed in transport from Spain, and will extend into early next
week, pushing back the start of production and reducing the number
of masks that can be produced before the end of January.
The Company looks forward to providing further updates in due
course.
Antony Legge, Chairman, said: "Achieving the EN14683 standard is
a great step forward as this was a key factor for potential
customers and the sales effort can now begin in earnest. The delay
in commissioning, caused by customs and transport difficulties in
Europe, has been very frustrating but it now should be just a
matter of a few days to complete the work."
- ENDS -
ENQUIRIES :
Remote Monitored Systems plc
Antony Legge (Chairman) +44 7394 489177
Alex Vergopoulos (Executive Director)
SP Angel Corporate Finance LLP +44 20 3470 0470
Nominated Adviser and Joint Broker
Stuart Gledhill
Caroline Rowe
Peterhouse Capital Limited +44 20 7469 0930
Joint Broker
Lucy Williams
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END
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