BSIF have provided the answers to the questions asked in good faith and to the best of our ability. BSIF cannot be held legally liable for the answers provided.
Question: Noticed some local groups, and maybe this is typical of the current help everyone is trying to help, that some eye protection equipment, visors, are being produced by people to supply the NHS at a local level and other health related companies, my question is should these companies have their products ran by a relevant trade body for certification and conformity ?
Yes. We believe that the motivation here is fantastic but it is essential that the products produced are fit for purpose. The Office of Product Safety and Standards has just published guidance entitled “New Small – Scale Manufacturers of COVID-19 Personal Protective Equipment (PPE)”this is available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/883462/Guidance-for-businesses-and-individuals-small-scale-manufacture-of-ppe-version-1.pdf
Question: There are countless news stories of things such as face shields being produced by schools, businesses etc. supplying direct into hospitals and care homes. Presumably many of these have not been approved by either of the routes under 2020/403? There is obviously a big risk in this and where does the liability rest?
Responsibility for selecting the correct PPE lies with an employer.
Question: Companies that are making visors using 3D printers to help with the COVID-19 shortage. These are being produced using open source designs but of course are not CE marked. Should these still be used given the current shortage of visors in healthcare settings?
Please see the answer above and refer to the OPSS guidelines https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/883462/Guidance-for-businesses-and-individuals-small-scale-manufacture-of-ppe-version-1.pdf
Question: Do Cat II products such as visors need a CE mark assessment from a NANDO notified body? We have had some advice that existing products, prior to COVID 19, didn’t need this and could be self-cert, only that new products being manufactured would require the ‘fast track’ certification from a NANDO body such as BSI
Eye protection is Category II and requires the involvement of a Notified Body. The single exception to this being sunglasses.
Question: We’re currently being asked regularly for medical spit shields for industrial sites. My feeling is, that if face screens are required in an industrial environment, even if it is for Covid-19, that the face screen must meet the EN166 standard. Does the BSIF have a position on this?
If it is for Eye and Face protection it should be under EN 166. PPE is any product designed to be worn or held by an individual. On the other hand if the screen is a barrier and used as an aid to social distancing it is not.
Question: Can you clarify the position on the validity of face shields that are being manufactured by individuals/small groups in response to the increased demand? I doubt if these products are being supplied with any documentation.
Please see previous answers and the reference to OPSS Guidance