CE FOR PROTECTIVE EQUIPMENT DONE!
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Special features of conformity assessment and CE labelling for personal protective equipment (PPE)
Special features at a glance:
- The PPE Regulation (EU) 2016/425 covers any device or means used to protect a person against damage to health
- There are three categories of PPE: 1 PPE only protects against minor risks. All PPE that does not fall under Cat. 1 or categorie. 3 are category. 2 PPE. Categories. 3 PPE protects against risks that can lead to very serious consequences such as death or irreversible damage to health.
- The requirements for the conformity assessment procedure depend on the category of PPE and go as far as mandatory type examination by a notified body for Cat. 3 PPE
REFERENCE PROJECTS
CE marking of Cat. 1 mouth-nose cover.
easyCE supports the entire conformity assessment procedure incl. instructions for use for an everyday mask as they are currently frequently used during the corona pandemic. Assessed as category 1 personal protective equipment.
CE marking and conformity assessment of a disinfection wristband.
easyCE supports the entire conformity assessment process, including the creation of a user supplement up to the declaration of conformity for a disinfection wristband ready for signature. Care has been taken to ensure that the disinfection wristband, as personal protective equipment, effectively protects the user from risks posed by bacteria, viruses, fungi and spores.
Considering: VO (EU) 2016/425, DIN EN 1500:2013
CE marking for FFP2 mask.
easyCE supports the entire conformity assessment procedure incl. instructions for use for an FFP2 mask in accordance with the Ordinance on Personal Protective Equipment. The mask is used to protect against the ingestion and spread of bacteria and viruses when speaking, sneezing, coughing and breathing in general. It should be noted in particular that PPE of a higher category, such as this FFP2 mask, requires testing by a notified body such as TÜV as part of the conformity assessment procedure. easyCE helped to organise and obtain all the necessary test reports.
Considering: 2016/425, EN 149:2001 + A1:2009
FAQ
According to which directives must protective equipment such as corona masks bear a CE mark?
Personal protective equipment must bear the CE mark in accordance with the Regulation on Personal Protective Equipment EU 2016/425. The distinction between
How is personal protective equipment defined and when is a product "personal protective equipment"?
The PPE Regulation (EU) 2016/425 covers any device or means used to protect a person against damage to health. There are three categories of PPE:
What process and requirements apply to the conformity assessment of personal protective equipment?
The requirements for the conformity assessment procedure depend on the category of PPE and go as far as mandatory type examination
What categories of personal protective equipment are provided for by Directive EU 2016/425?
There are three categories of PPE:
As a manufacturer or importer of personal protective equipment, what do I have to take into account for conformity assessment and CE labelling?
easyCE will be happy to help you identify the directives and standards that apply to your product.
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