標準號：IS 12572 Pt.4-1988
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 4 ) describes a method of test designed to provide information on the acute toxic effects attributable to leachable inherent or extraneous substances present in or on a medical device.1.2 This method specifies the use of a polar and non-polar solvent to obtain extracts that are administered as a parenteral dose to mice and assessed for acute toxicity 3 to 14 days later.1.3 This method of test is recommended for the initial assessment of devices in Category A, B1, C and E1 ( 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 prosthesis;b) Category B1— Those 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 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;d) Category E1 — Those intended to contain or administer substances including blocd, that are introduced parenterally into the body, for example, blood bags, haemodia-lysis equipment, intravenous administration sets and kits, and hypodermic syringes.