Biocompatibility standard ISO 10993

For medical devices that directly or indirectly contact patients, biocompatibility testing is required to obtain regulatory approval in most markets. Biocompatibility tests help determine whether a device performs as intended without causing any adverse or harmful effects for patients or users, and mitigate any biological risks posed by the device.
ISO 10993 is the key standard used for medical device biocompatibility testing. The standard has 20 parts; the first part is ISO 10993-1 that provides information on how to evaluate the biological risk. The other sections define detailed test methods for different kinds of tests.

In order to include biological safety in the design of a new device, the ISO 10993-1 should be considered during the early stages of the design.

Designers shall define if the device is intended for short time, long time or permanent use and the amount of device invasiveness (intact skin, breached skin, blood, tissues and so on).

According to this device description, the ISO 10993-1 provides areas of interest and test methods to determine the biocompatibility risk potential. Of course, the testing for an implantable permanent medical device is more thorough than the testing for a device that comes in contact with intact skin for a very short time.

Since the testing for biocompatibility involves chemical, physical characterisation and also in vitro and in vivo testing for some device categories, designers are invited to review current information in the literature before planning for material testing.