ANSI AAMI ISO 15676 pdf free download
ANSI AAMI ISO 15676 pdf free download.Cardiovascular implants and artificial organs- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO).
4.3 Performance characteristics
4.3.1 Priming volume
The priming volume shall be measured or calculated and reported in 6.2 e). Results shall indicate the priming volume over the entire range of tubing size provided by the manufacturer. Testing shall be performed according to the manufacturer’s protocol.
Some of these tests may be combined and performed at the same time.
4.3.2 LIfe to failure testing
The labelled anticipated lifetime of the roller pump boot tubing should be a figure not exceeding the lifetime of tubing as determined using the test specified in 5.4.1. The tubing shall be tested under the operating variables specified by the manufacturer in 6.2 c) for each available size and wall thicknesses of tubing. The results of these tests shall be reported as mean and standard deviation in 6.3 d).
4.3.3 Spallation
When tubing intended for use in a peristaltic pump is tested in accordance with 5.4.2, the spalled particles shall not exceed the level specified by the manufacturer.
4.3.4 Shelf life
When tested in accordance with 5.4.3, test results shall demonstrate the rated shelf life as specified by the manufacturer.
5 Tests and measurements
5.1 General
5.1.1 Tests and measurements shall be performed with the device under test prepared according to the manufacturer’s instructions for intended clinical use.
5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.
5.1.3 According to the intended clinical use of the tubing, the temperature of test liquids shall be 4 °C, 30 °C and
39 °C, or other temperatures to reflect typical and extreme use conditions.
5.1.4 If the relationship between variables is nonlinear, sufficient determinations shall be made to permit valid interpolation between data points.
5.1.5 The test or measurement procedures are to be regarded as reference procedures. Other procedures can be accepted provided that the alternative procedure has been shown to be of comparable precision and reproducibility.
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity
Sterility and non-pyrogenicity shall be determined in accordance with the requirements of ISO 17665-1, ISO 11135, ISO 11137-1, ISO 11137-2 and ISO 14937, as applicable.
5.2.2 Biocompatibility
Biocompatibility shall be determined in accordance with the requirements of ISO 10993-1 and ISO 10993-11. If the product is sterilized with ethylene oxide, biocompatibility shall also be tested in accordance with the requirements of
ISO 10993-7.
5.3 Physical characteristics
5.3.1 Blood pathway Integrity
5.3.1.1 The test shall be performed at 37 °C with air or water at the appropriate pressures. The test shall be performed to ensure freedom from leaking.
5.3.1.2 Subject the tubing to a positive pressure of 1,5 times the manufacturer’s rated pressure or, if no maximum pressure is specified, the test shall be performed at 152 kPa for 6 h or as long as it is specified by the manufacturer for clinical use. Using air pressure decay or visual inspection, check for leakage.
5.3.2 Connections
The connections shall withstand a pull force of 15 N for 15 s without separating. Testing shall be performed as specified in the manufacturer’s protocol.
5.3.3 Tubing material property testing
Tubing material property testing shall be determined in accordance with the requirements of ISO 34-1, ISO 527-1, ISO 9352, ASTM D792-00, and ASTM D2240-04, as applicable or consistent with the requirements of the end user.
ANSI AAMI ISO 15676 pdf download.
