Medical biotextiles implant

Collecting all the relevant information and maintaining documentation is very important for retrieval studies. Information about the implant manufacturer, the dates of implantation and explantation, the reason for retrieval, the patient s or animal s age and sex, the subject s health and medical state and the condition of the biotextile implant at the time of explantation. 

Biotextiles as medical implants Edited byM. King andB. Gupta... 

The European Union Medical Device Directive (and various other national systems) has adopted a review scheme known as the Essential Requirements Checklist. The manufacturer must meet the essential requirements of the Directive, which is a standardized grouping of attributes for medical products. All devices, regardless of classification or conformity assessment route, must prove that the product meets the essential requirements. Where a harmonized standard exists for the product, and the product meets the standard, it is deemed to automatically meet the essential requirements, but for biotextUes, these are few and far between. One notable device-specific standard for a biotextile vascular graft is ISO 7198 First edition 1998-08-01 Cardiovascular implants - Tubular vascular prostheses, which is recognized by FDA. 

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