IS 12572 : Part 3 : 1988 Guide for evaluation of medical devices for biological hazards Part 3 Method of testing by tissue implantation

1 Scope

1.1 This standard (Part 3) describes a method of test designedto provide information on the effects of direct contact of a testmaterial with living tissue when implanted into the paravertebralmuscle of the rabbit for a period of 7 days.

1.2 This method of test is recommended in the initial assessmentof devices in category A and C (see Part 2 of this standard):

a) Category A - Those devices intended for long-term (long-termcovers a period from a few months to permanent use) implantationwithin the body tissue, for example, artery grafts and hipprostheses; and

b) Category C - Those intended for short-term (short-term coversa period from a few minutes to several weeks continuous use) usewithin the body or in contact with the mucosal surfaces, forexample, tracheal tubes, urinary catheters and intravenouscannulae.