ISO 8638:2010 pdf free download – Cardiovascular implants and extracorporeal systems一Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters.
4.4.9 Transducer protectors
4.4.9.1 Integral transducer protectors
Extracorporeal blood circuits supplied with integral transducer protectors shall be capable of preventing cross-contamination. The transducer protector shall be capable of maintaining a secure and leak-free connection to the haemodialysis machine when subjected to pressures of 1,5 x the manufacturer’s recommended maximum pressure for the device. The machine side of the transducer protector shall be transparent (clear) to allow for visual inspection of blood contamination during use. Compliance with this requirement shall be in accordance with 5.5.9.
4.4.9.2 Non-integral transducer protectors
If not supplied as an integral component of the extracorporeal blood circuit, connectors shall be provided to allow the use of a transducer protector to prevent cross contamination. The transducer protector shall be capable of maintaining a secure and leak-free connection to the haemodialysis machine when subjected to pressures of 1,5 x the manufacturer’s recommended maximum pressure for the device. The machine side of the transducer protector shall be transparent (clear) to allow for visual inspection of blood contamination during use. Compliance with this requirement shall be in accordance with 5.5.9.
4.4.10 Blood pathway flow dynamics
Extracorporeal blood pathways shall be designed to minimize harmful effects to the blood components.
Compliance with this requirement shall be verified in accordance with 5.5.10.
4.4.11 Pump segment performance
The performance characteristics of the pump segment shall be evaluated over the range of inlet pressures
(normally 0 mmHg to —250 mm Hg).
Compliance with this requirement shall be verified in accordance with 5.5.11.
4.5 Expiry date
If the expiry date is given, it shall be validated. Accelerated stability studies are acceptable if real time data are not available. Compliance with this requirement shall be verified in accordance with 5.6.
4.6 Tubing compliance
The blood tubing shall be capable of being occlusively clamped by the venous line clamp of the dialysis delivery system(s) with which the extracorporeal blood circuit is intended to be used, as indicated in the labelling for the blood tubing. Compliance with this requirement shall be verified in accordance with 5.7.
5 Test methods
5.1 General
The performance characteristics specified in Clause 4 shall be determined prior to marketing a new type of device and shall be re-evaluated after changes in the device that might alter its performance.
The sample of devices shall be drawn at random from the manufacturer’s production and shall have passed all applicable quality control steps, as well as sterilization, if applicable. They shall be prepared according to the manufacturer’s recommendations as though they are to be used for a clinical procedure.
Measurements shall be made in vitro at (37 ± 1) °C. When the relationship between variables is non-linear, sufficient determinations shall be made to permit interpolation between the data points. The techniques of measurement are reference tests. Other test methods may be used, provided it can be shown that they are validated and of comparable precision and reproducibility.
The test systems shown do not indicate all the necessary details of practicable test apparatus. The design and construction of actual test systems and their establishment shall also address the many factors contributing to measurement error, including, but not limited to, pressure measurement errors due to static head effects and dynamic pressure drops; parameter stabilization time; uncontrolled temperature variations at non-constant flow rates; pH; degradation of test substances due to heat, light and time; degassing of test fluids; trapped air; and system contamination by foreign material, algae and bacteria.
5.2 Biological safety
The biological safety of devices that are intended to come into direct or indirect contact with the patient’s blood shall be evaluated on samples of each new type of device prior to its marketing or after any change in the materials of construction of that type of device or after any change in the method of sterilization. Testing shall be carried out in accordance with ISO 10993-1, ISO 10993-4 or ISO 10993-7, as relevant.