Biocompatibility
What is a Biocompatible Medical Device?
In short, it’s how a material — known as a biomaterial — interacts with a living organism, referred to as a host. More colloquially, biocompatible materials are those used in medical devices within or touching the human body. The majority of products manufactured at Crescenzia Wellness are made from biocompatible polymers.
Biocompatibility means “the ability of a material or device to interact with biological systems without causing adverse effects.” So it’s not just about how well something works in vitro (in test tubes) but also how well it works in vivo (in living organisms).
Facts About Biocompatibility
The term “biocompatibility” is ambiguous because it reflects the ongoing development of knowledge about how materials interact with the human body and can ultimately determine the success of a medical device (such as a pacemaker, catheter or stent). Modern medical devices and prostheses are typically composed of multiple materials, which means that describing their biocompatibility alone may not be sufficient.
In India, As in the the Fourth Schedule, Part-III, Appendix-II of the Medical Devices Rules, 2017, biocompatibility study have been mandated depending on the classification of the medical devices. The same needs to be updated in the Device Master File of the medical device. This means the appropriate ISO 10993 (Biological Evaluation of Medical Devices) tests have been followed for conducting biocompatibility study of menstrual cups manufactured in our facility. We have prepared a report of biocompatibility study along with rationale for selecting specific tests carried out including conclusion of the study.
