h

BIOCOMPATIBILITY OF MEDICAL DEVICES

ISO 10993

PHYCHER HAS BEEN EVALUATING THE BIOCOMPATIBILITY OF MEDICAL DEVICES AND MATERIALS INTENDED FOR USE IN MEDICAL DEVICES FOR OVER 10 YEARS ACCORDING TO ISO 10993-1.

Medical devices are classified according to the table 1 of the norm 10993 according the nature of the contact and its duration, ISO 10993 indicates the list of studies to perform for biomaterial, medical devices or dental devices.

Phycher offers all biocompatibility studies to conform to the table I of ISO 10993, from cytotoxicity to local tolerance to implantation, hemocompatibility…

Phycher also offers pre study of your file to guide you in the choice of the studies..

Phycher can also offer services and expertise : risk analysis, gap analysis, Biological Risk Assessment, Worst Cases definition, evaluation, ISO 10993-17…

Phycher is fully GLP certified. Therefore all studies are GLP compliants. Reports can be used anywhere in the world (CE mark, FDA, Japan…)

We call you back