Personal protective equipment (PPE) being defined more or less uniformly by the legislations as “all equipment, device or device specially designed and manufactured to preserve the human body, in whole or in part, from specific risks of occupational accidents or occupational diseases” These are made up of specialized pieces of clothing such as gloves, helmets, goggles, mask, etc. They are necessary to improve the health and safety conditions of workers while minimizing the risks to which they could be exposed to such as biological, calorific, physical or chemical risks.

This kind of products are regulated, both at the European level and throughout the world at the national level.

Important regulations on this matter are Personal Protection Directive 89/686 / CEE, relative to the use of PPE at work, and the Regulation on personal protective equipment (EU) 425/2016, relative to the design and manufacture of PPE. It should be noted that Regulation 425/2016 repealed directive 89/686 / CEE, becoming effective as of April 21, 2018. However, equipment that has the CE mark in accordance with the previous directive can stay on the market until the expiration date of the certificate.

As of April 21, 2023, only those CE certificates that follow regulation 425/2016 will be effective.

At Bionok Healthcare we process and advise you throughout the process of compliance with the regulations, characterization, definition of materials used and tests necessary for their management.

– Selection of an Authorized European Representative (for manufacturers outside the European Union).

– Obtaining the CE Marking through a Notifying Body, necessary for high-risk PPE (Category II and III)