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In the European standard EN 455-4, the requirements for determining the shelf life of disposable medical gloves are explained and test methods are presented. This standard, which is a set of standards, has been published by the Turkish Standards Institute in our country with the following headings:
The EN 455-4 standard contains requirements and test methods for determining the shelf life of disposable gloves. This standard provides a protocol to be followed to evaluate the shelf life of gloves using real-time studies or a properly validated alternative.
Medical gloves are designed as a barrier against agents responsible for the transmission of infections. To help ensure effectiveness, it is important that the gloves have sufficient physical strength so that they fit properly in the hand, are free of holes and do not deteriorate during use. All these problems are addressed in the EN 455 series of standards. This European standard covers minimum specifications that meet certain basic requirements detailed in the medical devices directive.
Manufacturers are required to conduct stability tests and initiate real-time stability studies to estimate the shelf life of any new or modified gloves before the product is released.
It is recommended that the shelf life be determined under special storage conditions specified for the product by the manufacturer, for example 25 degrees. Manufacturer The firm must specify the temperature along with the shelf life or expiry date. Accelerated aging studies are carried out on gloves to determine the shelf life in real time.
With the experience gained over many years, our organization also provides test services for the determination of the shelf life of EN 455-4 disposable medical gloves within the framework of laboratory services of the materials with a trained and expert staff.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
Our organization operates in a nationally and internationally approved, independent and impartial manner, in order to increase the product quality of enterprises and to prevent possible commercial risks in international trade. It provides audit, surveillance, inspection, testing, measurement and analysis services for businesses of all sectors and sizes, evaluates, reports and documents.
