Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

EN 13795 Evaluation of medical textiles

As a medical device, textiles used in operating theatres have to be conform with the requirements of the European Medical Devices Regulation 2017/745.
They are tested according to EN 13795 -- Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment.

EN 14683 Medical face masks - Requirements and test methods

Infective agents can be transmitted during surgical procedures in operating theatres and other medical settings in several ways. One of the important sources are the noses and mouths of the surgical team. When breathing, speaking, coughing or sneezing, a person releases smaller or larger amounts of droplets of secretions from the mucous membranes in the mouth and nose. Those droplets quickly evaporate and leave nuclei suspended in the air. Nuclei can subsequently spread through the air to a susceptible site such as an open operating wound or sterile equipment, or can be inhaled if dimensions

EN 14126 Evaluating PPE against infectious diseases

Centexbel is fully equipped to analyse these PPE and is a worldwide acknowledged expert in the evaluation of protective clothing against these infectious diseases.

ISO 16604 / ISO 22610 / ISO 22611 / ISO 22612 Barrier properties of textiles

Centexbel has the knowhow and equipment to assess the barrier properties of textiles, surgical gowns, masks and drapes, against microorganisms and blood.

ISO 10993-5 Biological evaluation of medical devices

To assess the health and safety risks linked with the skin contact with medical devices, Centexbel examines their toxic effect on the skin (cytotoxicity, irritation, sensitivity,…) according to ISO 10993-5 “Biological evaluation of medical devices – part 5 - cytotoxicity : in vitro methods”

Viral Filtration Efficiency (VFE) of surgical masks

As part of an ongoing pre-normative project, Centexbel is evaluating the possibility of testing surgical masks for their virus barrier. The aim of this project is to demonstrate the filtration efficiency of different types of masks in relation to very small biological structures, the viruses.

In vitro Biocompatiblity test

Flow cytometry is a laser- or impedance-based, biophysical technology employed in cell counting, cell sorting, bio-marker detection and protein engineering, by suspending cells in a stream of fluid and passing them by an electronic detection apparatus. It allows simultaneous multi-parametric analysis of the physical and chemical characteristics of up to thousands of particles per second.

Laser beam resistance

A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The term “laser” originated as an acronym for “light amplification by stimulated emission of radiation”. Although frequenlty used in surgery, it is essential that the patient is protected with laser resistant surgical drapes.