Bio Compatibility

What is a Bio Compatibility?

The word biocompatibility refers to the interaction of a living system or tissue with a finished medical device or component materials.

A common dictionary definition is, “the quality of being compatible with living tissue or a living system by not being toxic or injurious and not causing immunological rejection.”

Biocompatibility is the material’s lack of interaction with living tissue or a living system by not being toxic, injurious, or physiologically reactive. A material that is biocompatible does not cause an immune response in a host.

What Makes a Medical-Grade Herb Grinder?

Biocompatibility testing is an important part of obtaining FDA approval to market a medical device. The first step of the approval process is to confirm that a product is a medical device as defined by section 201(h) of the FD&C Act.

The FDA groups devices into three classes, so the second step is to classify the device. Class I devices have the lowest risk, and class III devices have the highest. Examples are exam gloves (class I), biopsy forceps (class II) and an artificial heart valve (class III). Classification is obtained from the FDA website. Go to “Medical Device Databases” under Tools & Resources. Search under “Product Classification” (general product name/keyword) or “Registration & Listing” (company name that makes a similar product or proprietary product name).

So, if we ever see an FDA classification for a grinder, it will fall in the class I or class II category.

The Minimum Requirements For a HAZARD-FREE Herb Grinder

Although USP Class VI testing is widely used and accepted in the medical products industry, some view it as the minimum requirement a material must meet to be considered for use in healthcare applications. Unfortunately, in most cases, low-grade grinders are made of industrial-grade materials, and there is no way of telling what they are made because the market is not overseen.

Source:

George A. Paleos, Pittsburgh Plastics Manufacturing, Butler, PA

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