European Authorized Representative

Biocompatibility Testing of Medical Devices – I3CGLOBAL

 When materials such as PVC began to be used, exposure to phthalates was a constant concern due to its harmful effects on health. These are plasticizing substances necessary to make plastic soft, widely used in the manufacture of sexual toys. 

Therefore, the health authorities have found it necessary to regulate these materials, however, some Asian countries use substances with the same properties but which are not regulated. 

Currently, several alternative plasticizers are available for medical applications. These include TOTM, DEHT, DINCH, and BTHC, all approved by the European Authorized Representative for medical applications. 

These new plasticizers allow healthcare professionals and patients to benefit from PVC's unique properties, such as softness, without the use of phthalates of interest.

The ISO 10993-1: 2018 standard establishes a guide on how to evaluate the Biocompatibility testing, this standard constitutes the standard in tests of this nature. The first part of this standard is the test selection guide, the second part includes animal welfare requirements, and the following sections cover specific test processes and other test-related issues.

The biocompatibility of medical devices is investigated using analytical chemistry, in vitro, and animal tests. The biocompatibility of a device depends mainly on the following factors:

  • The chemical and physical structure of the component materials.
  • Types of patient tissue to expose to the device.
  • Exposure time to this device.

The biocompatibility assessment of a medical device is done to ensure patient safety and is necessary whenever the device is in contact with tissue. When scheduling a biocompatibility test, manufacturers must consider their compliance goals and risks. 

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