IS 12572 : Part 6 : 1988 Guide for evaluation of medical devices for biological hazards Part 6 Method of test for systemic toxicity; assessment of pyrogenicity in rabits of extracts from medical devices

1 Scope

1.1 This standard (Part 6) describes a method of test designedto identify the presence of pyrogenic materials in or on medicaldevices. This method specifies measurement of the rise in bodytemperature of rabbits during a period of 3 h following anintravenous injection of an extract of the device, prepared withpyrogen-free saline.

1.2 This method of test is recommended for the initialassessment of devices in Categories A, B₁, C andE₁ (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;

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 the mucosalsurfaces, for example, tracheal tubes, urinary catheters andintravenous cannulae;

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.