ANSI AAMI ISO 15675 pdf free download

ANSI AAMI ISO 15675 pdf free download.Cardiovascular implants and artifcial organs— Cardiopulmonary bypass systems—Arterial blood line flters.
3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at http://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/ 3.1 arterial blood line filter accessory device used as part of the cardiopulmonary bypass system in the arterial blood return line for filtering particles such as blood clots, debris and gas emboli from the blood 3.2 blood pathway paths of the arterial blood line filter (3.1 ) containing blood during its intended clinical use 3.3 blood cell damage loss or destruction of cellular components of the blood components 3.4 platelet reduction percentage reduction of platelets contained in a circuit, as a function of time 3.5 plasma-free haemoglobin level difference between the concentration of plasma-free haemoglobin in a circuit, as a function of time 3.8 blood analogue test solution which simulates blood viscosity between 2.0 × 1 0 −3 Pa·s (2.0 cP), to 3.5 × 1 0 −3 Pa·s (3.5 cP) 3.9 bubble eliminator device that can remove bubbles 3.10 predicate arterial filter similar arterial filter to the test arterial filter that has previously been approved and used for the same intended clinical use 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance with 5.2.1 . 4.1.2 Biocompatibility The parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in accordance with 5.2.2. 4.2 Physical characteristics 4.2.1 Blood pathway integrity When tested in accordance with 5.3.1 , the blood pathway shall not leak. 4.2.2 Blood volume The volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).4.2.3 Connectors Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.3, allow a secure connection. Connection for accessory ports shall meet the requirements of ISO 594-2. NOTE 1 Connectors of a type that allows connection of tubes with an inside diameter of 4.8 mm, 6.3 mm, 9.5 mm or 1 2.7 mm, or a type that complies with ISO 8637:201 0, Figure 1 , or a type that complies with ISO 594-2, have been found satisfactory. NOTE 2 Connectors corresponding to ISO 8637:201 0, Figure 3 are considered as one way to comply with this requirement. 4.3 Performance characteristics 4.3.1 Blood cell damage When determined in accordance with 5.4.1 , the percentage change (positive or negative) of plasma-free haemoglobin, platelets, and white blood cells, shall be within the range of values specified by the manufacturer. The hemolysis results shall be reported as mg/dL and NIH.4.3.2 Filtration efficiency When tested in accordance with 5.4.2, the filtration efficiency of any individual filter shall be at least 80 % when tested with particles that are 20 % larger than the nominal pore size of the filter. 4.3.3 Flow rate capacity When tested in accordance with 5.4.3, test results will demonstrate the flow rate and pressure limitation(s) to ensure safe and effective performance, as specified by the manufacturer. 4.3.4 Shelf life When tested in accordance with 5.4.4, test results shall demonstrate the rated shelf life, as specified by the manufacturer. 4.3.5 Air-handling capability When tested in accordance with 5.4.5, test results shall demonstrate the air-handling capability, as specified by the manufacturer.ANSI AAMI ISO 15675 pdf download.