ANSI AAMI ISO 8638-2010 pdf download.Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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 hemodialysis machine when subjected to pressures of 1 .5 × 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 tracer pnsdurotectors
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 hemodialysis machine when subjected to pressures of 1 .5 × 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.
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 1 0993-1 , ISO 1 0993-4 or ISO 1 0993-7, as relevant.
6.3 Labeling on the outer container
At least the following information shall appear on the outer container:
a) the manufacturer’s name and address;
b) the name and address of the distributor, if different from the information given under a), if applicable
and in accordance with national requirements;
c) the proprietary device name, description of contents and number of devices contained in the outer
container;
d) the manufacturer’s identifying code for the device;
e) the lot number;
f) a statement of sterility and nonpyrogenicity;
g) the expiry date, stated as mm/yyyy or yyyy/mm;
h) instructions and warnings regarding handling and storage.
NOTE In all cases, symbols from ISO 7000 or ISO 1 5223 can be used where appropriate.
6.4 Accompanying documentation
At least the following information shall be supplied with each outer container:
a) the manufacturer’s name and address;
b) the proprietary device name;
c) the manufacturer’s identifying code for the device;
d) a statement of sterility and nonpyrogenicity and method of sterilization;
e) a statement of single use;ANSI AAMI ISO 8638-2010 pdf download
