ANSI AAMI ISO 7199 pdf free download

ANSI AAMI ISO 7199 pdf free download.Cardiovascular implants and artificial organs- Blood-gas exchangers (oxygenators).
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
All 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 Heat exchanger fluid pathway Integrity
When tested in accordance with 5.3.2, the heat exchanger fluid pathway shall not leak.
4.2.3 Blood volumes
When tested in accordance with 5.3.3, the volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).
4.2.4 Connectors
Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.4, allow a secure connection.
NOTE 1 Connectors of a type that allows connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5 mm or 12,7 mm, or a type that complies with ISO 8637:2010, Figure 1, or a type that complies with ISO 594-2, have been found satisfactory.
When tested in accordance with 5.3.4, the gas inlet connection to the gas pathway shall not separate.
Connectors for the heat exchanger fluid pathway shall be capable of being connected using fast couplings.
NOTE 2 Connectors corresponding to ISO 8637:2010, Figure 3 are considered as one way to comply with this
requirement.
4.3 Performance characteristics
4.3.1 Oxygen and carbon dioxide transfer rates
When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall be within the range of values specified by the manufacturer (see 6.3).
4.3.2 Heat exchanger performance factor
When determined in accordance with 5.4.2, the heat exchanger performance factors shall be within the range of values specified by the manufacturer (see 6.3).
4.3.3 Integral arterial filtration efficiency
When tested in accordance with 5.4.5, filtration efficiency of any individual device should be at least 80 % when tested with particles that are 20 % larger than the nominal pore size of the filter.
4.3.4 Integral arterial filter flow rate capacity
When tested in accordance with 5.4.6, test results will demonstrate the flow rate and pressure limitation(s) to ensure safe and effective performance, as specified by the manufacturer.
4.3.5 Integral arterial filter air handling capability
When tested in accordance with 5.4.7, test results shall demonstrate the air-handling capability, as specified by the manufacturer.
4.3.6 Blood cell damage
4.3.6.1 Plasma-free haemoglobin
When determined in accordance with 5.4.3, the increased concentration of plasma-free haemoglobin shall be within the range of values specified by the manufacturer.
The haemolysis results shall be reported as mg/dl and NIH.
4.3.6.2 Platelet reduction and white blood cell reduction
When determined in accordance with 5.4.3, the percentage reduction of platelets and the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer.
4.3.7 Time-dependent performance changes
When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall remain consistent within the range of values over the duration of the testing specified by the manufacturer.
4.3.8 Shelf life
When tested in accordance with 5.4.4, test results should demonstrate the rated shelf life, as specified by the manufacturer.ANSI AAMI ISO 7199 pdf download.