1.1 This standard ( Part 3 ) describes a method of test designed to provide information on the effects of direct contact of a test material with living tissue when implanted into the paravertebral muscle of the rabbit for a period of 7 days.
1.2 This method of test is recommended in the initial assessment of devices in category A and C ( see Part 2 of this standard ) :
a) Category A — Those intended for long-term (long-term covers a period from a few months to permanent use) implantation within the body tissue, for example, artery grafts and hip prostheses; and
b) Category C — Those intended for short-term (short-term covers a period from a few minutes to several weeks continuous use) use within the body or in contact with mucosal surfaces, for example, tracheal tubes, urinary catheters and intravenous cannulae.
IS 12572 Pt.3-1988 history
1989IS 12572 Pt.3-1988 Guidelines for Biohazard Assessment of Medical Devices Part 3 Tissue Implantation Test Methods