COVID-19, COVID-19… Needless to say, it is everyone’s duty to tackle and eliminate the virus with the tools provided by those governing. Precisely, tools for manufacturers of medical devices are what BSI, acting in its role as the UK National Standards Body, has been providing lately.
Along with the UK Advisory Group of expert healthcare, consumers and retail representatives, the Notified Body agreed and brought forward a specification for community face coverings being placed on the UK market
Public comments to shape and benefit the community face coverings standard
Since March 2021, the standard Flex 5555 has benefitted from public comments, which have led to enhance its environmental considerations to strengthen its labelling guidance, cleaning, fitting and breathing resistance inter alia. The outcome of the above has been the second version of the standard, which is freely available for use to aid UK manufacturers, retailers and even consumers, and it can be downloaded from here. All of this aimed at ensuring safety of single and re-usable face coverings. The standard has been warmly welcomed by the industry, given the gradual easing of lockdown restrictions across the UK and the need for protection.
Version 2.1 of BSI Flex 5555 Community face coverings
With this latest update of the standard Flex 5555, the major improvement has been the introduction of changes to the filtration efficiency requirements, as well as on the material filtration efficiency test.
The specifications are focused on securing face masks to protect both the wearer and those surrounding him/her, by limiting penetration by respiratory droplets from another person.
In a nutshell, the standard provides:
- Minimum performance requirements with regard to filtration;
- General information on single and multi-use face coverings;
- A method of test for testing houses; and
- Reassurance for retailers and consumers.
In principle, the specification does not cover PPE or medical face covering.[/vc_column_text]
Carlos Francisco Marín Barrios
Regulatory Affairs Department
02/06/2021
Should you like to know if you can use the standard during the manufacturing of your masks, or if you simply wish to enter the UK market with your devices and need help with their classification, do not hesitate and contact our experts at Obelis.com.
Bibliography:
BSI. (2021). Community face coverings – Specification. Retrieved on 02/06/2021 from https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/community-face-coverings/