ANSI AAMI ISO 15674 pdf free download

ANSI AAMI ISO 15674 pdf free download.Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags.
4.2 Physical characteristics
4.2.1 General
When tested in accordance with 5.3.1 and 5.3.2, the blood pathway shall not leak.
4.2.2 Blood volumes
The volume of the blood pathway shall be within the tolerances specified by the manufacturer [see 6.3 k)J.
4.2.3 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 used.
NOTE 2 Connectors corresponding to ISO 8637:2010, Figure 3 are considered as one way to comply with this requirement.
4.3 Performance characteristics
NOTE 1 Guidance for testing is given in Annex A.
NOTE 2 Some of these tests can be combined and performed at the same time.
4.3.1 Blood cell damage
4.3.1.1 Plasma-free haemoglobin
When determined in accordance with 5.3.4, the increased concentration of plasma-free haemoglobin shall be within the range of values specified by the manufacturer.
The hemolysis results shall be reported as mg/dL and NIH.
4.3.1.2 Platelet reduction and white blood cell reduction
When determined in accordance with 5.3.4, the percentage reduction of platelets and the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer.
4.3.2 Air-handling capacity
Testing to demonstrate the air-handling characteristics shall be conducted at various flow rates and the results shall be recorded [see 6.3 p)]. The test shall be conducted according to the manufacturer’s protocols.
4.3.3 Priming volume of the reservoirs in accordance with the manufacturer’s quality control management system
The volume of the reservoir(s) shall be determined and the results presented in accordance with 6.3 0). Testing shall be conducted according to the manufacturer’s protocols.
4.3.4 Defoaming characteristics
Where applicable, the defoaming characteristics shall be determined and the results shall be recorded [see 6.3 p)]. The testing shall be conducted according to the manufacturer’s protocols.
4.3.5 Volume calibration
Where applicable, the accuracy of the volume markings shall be measured and tolerances shall be presented as required in 6.3 n). The testing shall be conducted according to the manufacturer’s protocols.
4.3.6 Filtration efficiency
The efficiency of the filter shall be determined by the manufacturer according to their protocol. The filter efficiency results shall be recorded [see 6.3 p)]. The testing shall be performed around the anticipated flow range of the filter.
4.3.7 Break-through volume
Where applicable, the break-through volume shall be measured and the results shall be recorded [see 6.3 p)]. The testing shall be performed according to the manufacturer’s protocols.
4.3.8 Dynamic priming volume
Where applicable, the dynamic priming volume applies to hard-shell cardiotomy/venous reservoir systems (with/without filter) and shall be measured and reported as in 6.3 k). Results shall indicate the priming volume over the entire range of flows specified by the manufacturer and operational volume used for the test. Testing shall be performed according to the manufacturer’s protocols.
4.3.9 Minimum and maximum volumes
The minimum and maximum volumes shall be specified by the manufacturers in the testing protocols.
4.3.10 Shelf life
When tested in accordance with 5.3.4, test results shall demonstrate the rated shelf life, as specified by the manufacturer.ANSI AAMI ISO 15674 pdf download.