BS ISO 8637-3:2018 pdf free.Extracorporeal systems for blood purification Part 3: Plasmafilters.
The performance characteristics specified in 4.3 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 device shall be drawn at random from the manufacturer’s production and shall have passed all applicable quality control steps, as well as sterilization. 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 nonlinear, sufficient determinations shall be made to permit interpolation between the data points. The techniques of measurement given in this document are reference tests. Other test methods may be used, provided they have been validated and shown to be precise and reproducible.
The test systems shown do not indicate all the necessary details of practicable test apparatus. The design and construction of actual test systems and the establishment of actual test systems 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 the non-constant flow rates; p1-I; 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.
The test methods below are reference methods. Other methods may be used, provided they have been shown to be of comparable precision and reproducibility.
NOTE Clause 5 contains tests that are of a type-testing nature, which are carried out prior to marketing of a new device or when changes are made to the device or its manufacturing processes (see 5.8).
Others are of a quality control nature, which are repeated on a regular basis to ensure that the device fulfils requirements (see 5.2, 5.3, 54, 5.5.1, 5.5.2).
5.2 Biological safety
The biological safety of plasmafilters 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, ISO 10993-7 or ISO 10993-11, as relevant.
5.3 Sterility
Conformity to 4.2 shall be verified by inspection of the records to show that the device has been exposed
to a validated sterilization process.
5.4 Non-pyrogenicity
Conformity to 43 shall be verified in accordance with ISO 10993-11.
The device shall be capable of withstanding a positive pressure of 1,5 times the manufacturer’s recommended maximum pressure above atmospheric pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric pressure) or the highest obtainable negative pressure if at high elevation, when tested according to 552.
NOTE This requirement relers to the external case integrity o the device.
Fill the device under test with water and subject the device to a 1,5 times the manufacturers recommended maximum pressure. Maintain this pressure for 10 mm and visually inspect the device for any emergence of water.
5.5.2 Blood compartment integrity
Set up the filter in the vertical position. Close off the bottom filtrate and blood ports. Wet the membrane with water and fill the filtrate compartment, if appropriate. Pressurize the blood compartment with air to 1,5 times the maximum transmembrane pressure specified by the manufacturer for a period of 10 mm. If no bubbles exit the filtrate compartment, through the open filtrate port, the blood compartment is intact.
5.5.3 Blood compartment ports
Conformity to 4.4.3.1 shall be determined by inspection. If a non locking connector is used, the connector shall not separate under an axial force of 15 N applied for 15 s.
5.5.4 Blood compartment volume
The volume of the compartment containing blood shall be calculated from geometrical data (volume of headers, fibre dimensions and the number of fibres). Conformity is checked by inspection of the manufacturer’s documentation.
NOTE The volume is calculated as described above since it might prove difficult to find a liquid that will not be filtered through a plasmafilter membrane.BS ISO 8637-3 pdf download.
Tags: Extracorporeal systems for blood purification
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