Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

Importancia y uso:

4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.

Subcomité:

F04.16

Referida por:

F0688-19, F0799-19, F0067-13R17, F0136-13R21E01, F1580-18, F1781-21, F2064-17, F3515-21, F0881-94R22, F0755-19, F1538-24, F2224-09R20, F2665-21, F2884-21, F0748-16, F1357-23, F2565-21, F0560-22, F2529-13R21, F0451-21, F0763-22, F0641-09R23, F1378-18E01, F2066-23, F0138-19, F0603-12R20, F0648-21, F1185-23, F0562-22, F2103-18, F2347-24, F1983-23, F2695-12R20, F1088-23, F0090-23, F0075-23, F2759-19, F1350-24, F1408-20A, F2721-09R23, E3219-20, F3089-23, F2212-20, F0561-19

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

biocompatibility; bone implant materials; cellular reaction; histology/histopathology; implants muscle; New Zealand rabbits; orthopaedic medical devices—bone; plastic surgical devices/applications; polyethylene (PE)—surgical implant applications; rabbits; rats; scar; test animals; tissue compatibility; tissue response evaluation;