IS 12572 : Part 5 : 1988 Guide for evaluation of medical devices for biological hazards Part 5 Method of test for intracutaneous reactivity of extracts from medical devices

1 Scope

1.1 This standard describes a method of test designed to assessthe localized reaction of tissue to leachable inherent orextraneous substances present in or on a medical device.

1.2 The method specifies use of a polar and non-polar solvent toobtain extracts that are administered as intracutaneous injectionsto rabbits and assessed for intracutaneous reactivity afterinjection at 24, 48 and 72 h thereafter.

1.3 This method of test is recommended for the initialassessment of devices in Categories A, B₁, C andE₁ (see IS 12572 : Part 2 : 1988).

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;

b) Category B₁ - Those devices intended forlong-term (long-term covers a period from a few months to permanentuse) or repeated contact with mucosal surfaces, for example,contraceptive devices;

c) Category C - Those devices intended for short-term(short-term covers a period from a few minutes to several weekscontinuous use) use within the body or in contact with mucosalsurfaces, for example, tracheal tubes, urinary catheters andintravenous cannulae; and

d) Category E₁ - Those devices intended tocontain or administer substances, including blood, that areintroduced paranterally into the body, for example, blood bags,hemodialysis equipment, intravenous administration sets and kitsand hypodermic syringes.