ABNT NBR 14990-1 Testing Packaging Systems and Materials for Sterilization of Medical Devices

Medical Tests

ABNT NBR 14990-1 Testing Packaging Systems and Materials for Sterilization of Medical Devices

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and rapid testing services within the scope of ABNT NBR 14990-1 test. This standard provides general criteria for sterility tests on medical devices treated with reduced sterilization agents compared to those expected to be used in routine sterilization process. specifies.

ABNT NBR 14990-1 Testing Packaging Systems and Materials for Sterilization of Medical Devices

A sterile medical device is one that is free from live microorganisms. International Standards specifying requirements for the validation and routine control of sterilization processes require that incidental microbiological contamination of a medical device from all sources be minimized when a sterile medical device has to be supplied.

However, medical devices produced under standard production conditions in accordance with the requirements of quality management systems may have microorganisms, albeit in small numbers, on them before sterilization. Such products are not sterile. The purpose of sterilization is to neutralize microbiological contaminants, thereby converting non-sterile products into sterile products.

The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices are generally best described by an exponential relationship between the number of surviving microorganisms and the sterilizing agent and the extent of treatment; inevitably this means that there is always a finite probability for a microorganism to survive, regardless of the extent of treatment administered.

The probability of survival for a given treatment is determined by the number and resistance of microorganisms and the environment in which the organisms are present during treatment. Therefore, the sterility of any item in a sterilized population cannot be guaranteed, and the sterility of a processed population is defined in terms of the probability that a viable microorganism may be present in a product item.

EUROLAB assists manufacturers with ABNT NBR 14990-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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