Medical Devices

According to NBR 14332 standard, corrosion and stains which appear on the instruments during their utilization may stem from the intrinsic properties of the instrument or from the cleaning and sterilization process.

The manufacturer shall:
1) Prove through corrosion resistance tests, chemical analysis and mechanical tests that his instruments conform to the established standards, i.e. that they possess acceptable intrinsic properties. Once these properties for metallic instruments have been established, they do not change with reprocessing.

2) Elaborate an efficient cleaning and sterilization user friendly procedure. If poorly conceived, a cleaning procedure is apt to stain and even corrode the instrument. The procedures for each cleaning and residue removal step as well as the used reagents must be clearly described and detailed. Upon validation of the instrument’s cleaning and sterilization process, the manufacturer can provide tests for quantification of soiling residue content and cleaning agents.

The user shall:
1) Observe with precision the steps of the cleaning and sterilization procedure defined by the instrument’s manufacturer. When the user observes adequately validated cleaning protocols, the lifespan of a stainless steel instrument or any other surgical metal is normally determined by the instrument’s waste or breakage.

How can CENIC Lab help?
CENIC Laboratory can help the manufacturer prove the intrinsic properties of the instrument by carrying out corrosion, mechanical and composition analysis tests. For more information see “Tests performed by CENIC Lab”.