標準號：IS 12572 Pt.6-1988
發布日期：1989/9/1 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：1.1 This standard ( Part 6 ) describes a method of test designed to identify the presence of pyrogenic materials in or on medical devices. This method specifies measurement of the rise in body tempera-ture of rabbits during a period of 3 h following an intravenous injection of an extract of the device, prepared with pyrogen-free saline.1.2 This method of test is recommended for the initial assessment of devices in Categories A, B1, C and E1 ( see Part 2 of this standard ):a) Category A — Those devices intended for long-term ( long-term covers a period from a few months to permanent use ) implanta-tion within the body tissue, for example, artery grafts and hip prostheses;b) Category B1 — Those devices intended for long-term (long-term covers a period from a few months to permanent use) 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 weeks continuous use ) use within the body or in contact with the mucosal surfaces, for example, tracheal tubes, urinary catheters and intravenous cannulae;d) Category E1 — Those devices intended to contain or administer substances, including blood, that are introduced paranterally into the body, for example, blood bags, hemo-dialysis equipment, intravenous administra-tion sets and kits and hypodermic syringes.