ANSI AAMI ISO 11658 pdf free download

ANSI AAMI ISO 11658 pdf free download.Cardiovascular implants and extracorporeal systems – Blood/tissue contact surface modifications for extracorporeal perfusion systems.
5.1.2 Operating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.
5.1.3 The temperature of the test liquid(s) shall be representative of a range of the intended clinical temperatures during device use (e.g. hypothermic, normothermic and/or hyperthermic). Tests should be performed at multiple temperatures over the range of the intended clinical use, or justification for testing at a single temperature should be provided (e.g. why this temperature is representative of the worst-case condition).
5.1.4 If the relationship between variables is non-linear, 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
Compliance shall be verified by inspection of the manufacturer’s documentation on sterilization and pyrogen testing, in accordance with ISO 17665-1, ISO 11135-1, ISO 11137-1, ISO 14937 or ISO 10993- 11, as applicable.
5.2.2 Biocompatibility
Compliance shall be verified by test or by inspection of the manufacturer’s documentation on biocompatibility for the finished device, in accordance with ISO 10993-1 and ISO 10993-7, as applicable.
5.2.3 Biological activity
Any biological activity claims shall be verified using validated methodology performed according to the manufacturer’s protocol. This shall not apply to surface modifications for which biological activity is not claimed.
EXAMPLE A claim of heparin activity can be verified with a test to evaluate the anticoagulant activity in terms of antithrombin uptake and the concomitant thrombin inhibitory capacity of the heparin present in the surface modification.
5.3 Physical characteristics
5.3.1 Determination of blood pathway integrity (sterile final assembly)
Devices that have established standards, such as oxygenators, reservoirs, tubing packs and arterial filters, shall use the prescribed methodology from their respective standard for testing.
In the absence of an established standard, subject the blood pathway of the device, filled with water, to a negative or positive pressure of 1.5 times the manufacturer’s rated pressure, or, if none is given, to a pressure of 152 kPa (22 psi) gauge. Maintain this pressure for 6 h or for the intended use time specified by the manufacturer. Visually inspect the device for evidence of water leakage.
5.3.2 Determination of surface modification coverage Any surface modification coverage claims shall be verified using validated methodology performed according to the manufacturer’s protocol. EXAMPLE A claim of coverage for a heparin-containing surface modification can be verified by treating coated devices with the cationic dye, toluidine blue. The dye is absorbed onto the negatively charged surface inducing a metachromatic shift in the color of the dye (blue to purple). The coverage of the stained surface is then visually inspected for purple color distribution.
5.3.3 Determination of surface modification integrity The integrity of the surface modification shall be verified using validated methodology performed according to the manufacturer’s protocol. Such testing shall be performed using an appropriate extraction media under conditions simulating the maximum rated conditions as specified for the device. These conditions shall include the temperature, flow rate, pressure, duration of testing (6 h or intended duration of use), and mechanical stress (such as roller pump compression of tubing indicated for use in a roller pump) for the intended purpose of the device specified by the manufacturer.ANSI AAMI ISO 11658 pdf download.