標(biāo)準(zhǔn)號：IS 12572 Pt.5-1988
發(fā)布日期：1989/7/1 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：1.1 This standard describes a method of test designed to assess the localized reaction of tissue to leachable inherent or extraneous substances present in or on a medical device.1.2 The method specifies use of a polar and non-polar solvent to obtain extracts that are adminis-tered as intracutaneous injections to rabbits and assessed for intracutaneous reactivity after injec-tion at 24, 48 and 72 h thereafter.1.3 The method of test is recommended for the initial assessment of devices in Categories A, B1, C and E1 ( see IS 12572 ( Part 2 ) : 1988.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 mucosal surfaces, for example, tracheal tubes, urinary catheters and intravenous cannulae; andd) Category E1 — Those devices intended to contain or administer substances including blood, that are introduced parenterally into the body, for example, blood bags, haemodialysis equipment, intravenous administration sets and kits and hypoder-mic syringes.