Regulations and
certifications
Regulations :
All our products comply with current regulatory requirements
Classification : PPE (Personal Protective Equipment)
PPE Regulations
Our product ranges comply with EU Regulation 2016/425. Category III products are assessed through a certification procedure, resulting in the award of an EC Type-Examination Certificate (AET).
PPE is classified into three categories :
– Category I – Minor risks (Self-certification – Simple CE marking)
– Category II – medium-risk products (EC type-examination certificate issued by a notified body)
– Category III – Complex PPE designed to provide protection against high-risk hazards. (EC type-examination certificate issued by a certified body + regular production checks at the manufacturer’s premises by an approved body).
Requirements and
types of protection
(clothing)
In order to market protective equipment, every manufacturer must affix a label to the garment indicating its classification. The manufacturer may only do so if the garment has first been tested in accordance with European standards and the results of these tests have been validated by an authorised independent body.
Classification : Respiratory protection masks
Classification : MD (Medical Devices)
Surgical drapes, gowns and scrubs, used as medical devices for patients, staff and equipment.
The purpose of the EN 13795 standard is to prevent the transmission of infectious agents in the operating theatre. It sets out the requirements for surgical drapes and surgical gowns based on their proximity to the surgical site and the risk of contamination, by identifying critical and non-critical areas.
Depending on the requirements the products must meet, the standard distinguishes between two performance levels:
– Standard performance: long-duration procedures with a moderate fluid load
– High performance: long-duration procedures with a high fluid load
All our Segedrape™ surgical drapes exceed the requirements of the EN 13795 standard for high performance in critical areas. Our Evercap® surgical gowns meet the requirements of various surgical procedures: high performance and standard performance in accordance with EN 13795.
All our products are latex-free.
Medical face masks
Masks are classified into three categories according to their bacterial filtration efficiency (BFE) as a percentage:
Type I : EFB ≥ 95
Type II : EFB ≥ 98
Type IIR : EFB ≥ 98
Type IIR refers to a mask that has been tested for resistance to splashes.
Our accreditations
Segetex-eif is committed to a policy of quality, safety and environmental responsibility, as evidenced by our various certifications.
Our approach is based on participatory management, with a particular focus on the well-being and safety of our teams. We are also committed to reducing our environmental footprint through concrete actions and the continuous improvement of our processes. Our certifications demonstrate this commitment and our dedication to social and environmental responsibility.
