All our sutures comply with the standards of European Pharmacopoeia 8th edition, and American Pharmacopoeia USP XXXIX and Ed. 2016 and the requirements of the European Directives for Medical Devices, Directive 93/42 EEC and Directive 2007/47 EEC.
An exhaustive analysis of the raw materials, as well as the entire manufacturing process and final product, are manufactured in a clean environment to minimize pollution.
The needles used for their production are of the highest quality and undergo rigorous quality control.
Control of raw materials
-Testing of atraumatic needles
Apart from tests on needle dimensions (length, diameter, hole size and depth), steel type and cosmetic aspects, Bending, Ductibility, Penetration and Corrosion tests are performed to ensure quality.
Length, diameter, strength and elasticity.
Control of packaging material
Needle thread union, labeling and packaging.
Length, diameter and strength. Gamma Ray and Ethylene Oxide sterilization according to standards. (ISO 11137 and ISO 11135) Absorption of synthetic sutures.