NF S94 402-1 Investigation of the Corrosive Effect of a Decontaminating, Disinfecting or Cleaning Agent on Reusable Medical-Surgical Instruments - Test Methods - Part 1: Stainless Steel

A French standard “NF S94 402-1 Investigation of the corrosive effect of a decontamination, disinfection or cleaning agent on reusable medical-surgical instruments - Test methods - Part 1: Stainless steel” describes a test method for the assessment of the possible corrosive effect of a pre-disinfectant, cleaner or disinfectant product used in a medical environment on stainless steel metal instruments.

The purpose of this standard is to evaluate the possible corrosive effects of stainless steel metal instruments, pre-disinfectants, cleaners and disinfectants used in medical environments through tests. In advanced laboratories, corrosion tests are performed on reusable stainless steel metal medical-surgical instruments in new condition and in accordance with current standards.

Reusable medical-surgical instruments covered by this standard are metallic and manufactured from one or more metallic materials.

The following are outside the scope of this standard:

• Assembly adhesives and sealants that may come into contact with pre-disinfectant, cleaning or disinfection products
• Elements that do not come into contact with pre-disinfectant products (e.g. engine)

For the purposes of this standard, the following terms and definitions apply:

• The products are the following types of products used for pre-disinfection, cleaning and disinfection purposes:
  • Product for pre-disinfection refers to the product used on a contaminated medical-surgical instrument before cleaning, in order to prevent contamination of the equipment users and the circuits it uses. This product should also facilitate the cleaning process.
  • Mouthwash for cleaning refers to the product or set of several products used in succession to obtain a surface free of dirt, stains, traces of organic or mineral chemicals on a previously disinfected medical-surgical instrument.
  • Mouthpiece for disinfection refers to the product used in the final process on a medical surgical instrument that has been previously disinfected and cleaned when it cannot be sterilized.
• A reusable metal medical-surgical instrument is any medical-surgical instrument, a device intended to perform a diagnostic or therapeutic procedure. This device must be capable of being reused on another patient without being a vector of pathogenic microbes after passing through one of three cycles:
  • Pre-disinfection, cleaning, chemical disinfection
  • Pre-disinfection, cleaning, disinfection, packaging and sterilization
  • Pre-disinfection, cleaning, packaging and sterilization
• Corrosion of a metallic material refers to the state of damage to this material. This is a complex phenomenon that occurs according to the electrochemical process between the surface of the material and the surrounding environment containing chemical substances. This environment can be characterized, in particular, by water, air and their products, temperature, light and similar conditions. The standard "ISO 10271 Dentistry - Determination of tarnish and corrosion of metals and alloys" developed by the International Organization for Standardization (ISO) describes the physical-chemical interaction between a metal or alloy and its environment, which causes partial or complete destruction of the material or changes in its properties.

Reusable medical-surgical instruments shall not show signs of corrosion, stains or deposits after being tested according to the simple immersion corrosion test method in accordance with this standard.

Plotting the intensity-potential polarization curve obtained from a metallic material immersed in an aqueous solution of a product of a specified concentration and at a specified temperature is the preferred method for evaluating and measuring the corrosive effect of such a product on a metallic material. In general, immersion testing consists of immersing specimens in a pool of sodium chloride solutions at room temperature.

Among the numerous tests, measurements, analyses and evaluation studies that our organization has carried out for businesses in various sectors, our organization also provides testing services defined in the standard “NF S94 402-1 Examination of the corrosive effect of a decontamination, disinfection or cleaning agent on reusable medical-surgical instruments - Test methods - Part 1: Stainless steel” with its trained and expert staff and advanced technological equipment.