What is BS EN ISO 10993-14:2014 ?

EN ISO 10993-7:2014 is an essential standard for medical devices that aims to ensure the safety and compatibility of these devices with human beings. The standard, issued by the International Organization for Standardization (ISO), specifically focuses on evaluating the biological effects of medical devices on living organisms.

In the field of medical devices, materials used in their construction must be biocompatible, meaning they do not cause an adverse reaction when in contact with the body. EN ISO 10993-7:2014 provides guidelines for assessing the potential toxicity of materials used in medical devices when they come into direct or indirect contact with the body.

The main objective of EN ISO 10993-7:2014 is to determine if a material used in a medical device can cause adverse biological reactions in humans. The standard emphasizes the importance of conducting thorough evaluation to identify any potential risks associated with these materials.

To evaluate the biocompatibility of a material, the standard provides several key requirements that must be met. These requirements include:

* The material must not cause irritation, redness, or itching when in contact with the skin, eyes, or oral cavity.

* The material must not cause an adverse reaction when in contact with vital organs, such as lungs, heart, or kidneys.

* The material must not cause inflammation or tissue necrosis when in contact with the skin or other tissues.

* The material must not have a negative impact on the body's immune system.

By evaluating materials for biocompatibility, medical devices can be designed with confidence that they are safe for use in the body. EN ISO 10993-7:2014 provides a framework for assessing the potential risks associated with medical device materials and provides guidelines for conducting tests to determine their biocompatibility.

In conclusion, EN ISO 10993-7:2014 is an essential standard for medical devices that aims to ensure their safety and compatibility with human beings. The standard provides guidelines for evaluating the potential adverse effects of medical device materials on living tissue and provides a framework for assessing their biocompatibility. By evaluating materials for biocompatibility, medical devices can be designed with confidence that they are safe for use in the body.