TS EN 455-4 Disposable Medical Gloves - Determination of Shelf Life

Protective Clothing Tests

TS EN 455-4 Disposable Medical Gloves - Determination of Shelf Life

The EN 455-4 standard, which describes the requirements and test methods for determining the shelf life of disposable medical gloves, is actually a European standard.

TS EN 455-4 Disposable Medical Gloves - Determination of Shelf Life

The EN 455 standard set is a series of standards, consisting of the following four sections, under the general heading of disposable medical gloves. This series of standards has been published in our country by the Turkish Standards Institute (TSE) with the following titles:

  • TS EN 455-1 Part 1: Properties and no hole test
  • TS EN 455-2 Part 2: Rules and experiments for physical properties
  • TS EN 455-3 Part 3: Properties and experiments for biological evaluation
  • TS EN 455-4 Part 4: Rules and experiments for determining shelf life

The EN 455 set of standards supports the essential requirements or other provisions of the medical devices directive 93/42 / EEC.

All gloves have a certain shelf life. During this time, these gloves must be able to meet the first three parts of the standard sequence in question. Therefore, the TS EN 455-4 standard explains how to test the shelf life of a glove and how to label it.

Two test methods are applied in this regard. The first is to speed up the shelf life. Gloves are subjected to different tests and theoretical shelf life is calculated based on the test results. When the shelf life determination is made according to accelerated tests in this way, the requested time is maximum three years. This test is normally done when a new glove is produced.

The second test method is real-time testing. For all gloves, real-time shelf life determination must also be initiated. Since the maximum shelf life for a glove is quite long (up to five years), this test takes years to complete.

Within the scope of protective clothing tests, our organization also provides TS EN 455-4 disposable medical glove test services.

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