Covid19 Pandemic and Personal Protective Equipments,

There two types of masks and coveralls for use during the Covid19 Pandemic. These masks are Particle Filtering Half Masks and Medical Face Masks. There are many economic operators to supply the emerging need for masks. In order to solve the need for masks, it is clear to support these economic operators, manufacturers. In the other hand it is very important that the masks on the market are suitable for the intended use. There are international standards and regulations for these masks to ensure the effectiveness and quality of these produts.

1.      Filtering half masks to protect against particles (Widely known as N95 or FFP1/2/3 )

a.      Standard: EN 149+A1:2009

b.      Regulation: Personal Protective Equipment (EU) 2016/425 – Category 3

c.      Conformity Assessment: Shall carry CE mark with the Notified Body Number. (i.e. CE 2163)

 

 

2.      Medical Face Masks 

a.      Standard: EN 14683+AC:2019

b.      Regulation: Medical Devices Regulation – Class1

c.      Conformity Assessment: Shall carry CE mark. (No need for the Notified Body Number)

 

3.      Coveralls 

a.      Standard: EN 14126:2003

b.      Regulation: Personal Protective Equipment (EU) 2016/425– Category 3

c.      Conformity Assessment: Shall carry CE mark with the Notified Body Number. (i.e. CE 2163)

As a Notified Body authorised by local government and European Commission, UNIVERSAL CERTIFICATION is well aware of its responsibility and the emerging need for personal protective equipment, and is working with its whole capabilities to serve the indutry and contribute providing suitable products for all community.

UNIVRESAL CERTIFICATION can provide all necessary testing services for the products and certification services.

You can find all necessary information about certificaton process, application forms and answers to the frequently asked questions

• Medical Face Masks (EN 14683 AC:2019)
• Particle Filtering Half Masks (EN 149+A1:2009)
• Coveralls(EN 14126:2003)