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ISO 8637-2010 pdf free download
ISO 8637-2010 pdf free download.Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Implants cardiovasculaires et système s ext racorporels — Hémodialyseurs, hémodiafiltres, hémofiltres et hémoconcentrateurs.
The performance characteristics specified in 4.5 shall be determined prior to marketing a new type of device arid shall be re-evaluated after changes in the device that might alter its performance. If labelled for multiple uses, devices shall be tested for clearances and ultrafiltration coefficient after reprocessing according to the manufacturer’s instructions to characterize the effects of the recommended cleaning agent and germicide on membrane 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 given in this International Standard 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; 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.
NOTE Clause 5 contains tests that are of a type-testing nature, such as the ones described in 5.5.1, 5.5.3. 5.5.4, 5.6.1. 5.6.2. 5.6,3 and 5.6.4. which are carried out prior to marketing of a new device or when changes are made to the device or its manufactuiing processes. Others are of a quality control nature, such as the ones described in 5.3. 5.4 and 5.5.2, which are repeated on a regular basis in accordance with quality management system requirements.
5.2 Biological safety
The biological safety of haemodialysers. haemodiafilters, haemofilters and haemoconcentrators 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. If labelled for multiple use, testing shall demonstrate the safety of the device befOre first use and after reprocessing according to the manufacturer’s instructions. Testing shall be carried out in accordance with ISO 10993-1, ISO 10993-4. ISO 10993-7 or ISO 10993-11, as relevant.
Compliance with 4.2 shall be verified by inspection of the records to show that the device has been exposed to a validated sterilization process.ISO 8637-2010 pdf free download.
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