The manufacturer's responsability
The manufacturer informs the user about the critical and less critical areas designed for its products as well as the addressed performance classification of its products
In the interest of the end-user
Standard EN 13795 is a global reference that enables the end-user to compare different options impartially to make a better choice.
The tests, the distinction between critical and less critical areas and the standard or high performance classification are the different parameters that will help the user to make the appropriate choice for a product.
In addition to the elements already provided by the manufacturer, the end-user can also require :
- The test results and the corresponding methods,
- The justification for the distinction between critical and less critical area
Keep in mind ! Any product will achieve all the highest performances as some of the performances criteria are opposed. The end-user will choose according to:
- the protection level according to its surgical process
- des the more appropriate characteristics according to his objective
