Disclaimer: This article is meant only for those who are planning to produce protective face shields in large quantities. If you want to print a couple of shields at home for your relatives, then you shouldn’t need a certification.
During the novel coronavirus pandemic, face shields became an important piece of protective equipment for frontline staff and many other people. The design, which we published at PrusaPrinters.org, became an important starting point for thousands of individuals and companies across the entire world. We have produced and donated over 200.000 face shields to those in need (we have documented this process in photos and video here).
However, the recently published information suggests that the pandemic is not over yet as the virus keeps spreading in several countries and it is difficult to stop it. What is even worse, there might be even a second wave later this year. Therefore, we believe it’s better to be prepared. Face shields may be required again. And this is where things get a bit complicated.
During a time of crisis, many countries introduced emergency measures and allowed frontline staff to use uncertified personal protective equipment (PPE). However, that was an exception – the distribution of home-made PPE was more or less tolerated, depending on how bad the situation with official PPE was. From our experience, doctors were happy to receive any sort of help. However, we still contacted the Czech Ministry of Health and received their official approval to manufacture and distribute face shields to medical, rescue, and social services.
Josef Prusa meeting Czech Minister of Health
Many individuals and companies across the world started manufacturing home-made PPE and distributed them to those in need. However, this is not going to work in a long-term perspective. There may be cases when a piece of PPE made in goodwill could, due to its imperfections, cause unforeseen trouble or even put a life at risk. This is why there are officially approved processes that include thorough testing before a certificate is granted. Now, if you’re planning to print just a few shields at home, e.g. for your relatives, then this process shouldn’t be mandatory – just make sure to test the shield’s functionality in cooperation with the person who is going to wear it and ensure that it offers a sufficient level of protection. However, if you plan to produce the shields in large volumes and supply frontline staff with these products, then it’s a different matter.
Face shields are classified as personal protective equipment and must comply with the requirements of Regulation 2016/425/EU of the European Parliament and of the Council on personal protective equipment before being introduced to the market. Currently, the European Commission Recommendation 2020/403 is also valid, which recommends tolerating certain formal deficiencies in case the importer/manufacturer possess documents proving that the properties of imported/manufactured ensure an adequate level of health protection and safety in accordance with the requirements of Regulation (EU) 2016/425. Furthermore, the documents must demonstrate that the manufacturer has already initiated necessary conformity assessment procedures.
We have applied for an official certification shortly after we started manufacturing our face shields. And we promised that once we get it, we’ll share our experience and findings with the rest of the community – to tread the path for others. Now, of course, thisContinue reading