BS EN ISO 20696:2018 pdf free
BS EN ISO 20696:2018 pdf free.Sterile urethral catheters for single use (ISO 20696:2018).
4 Intended performance
The urethral catheter shall demonstrate the ability to accurately and safely access the intended location.
The urethral catheter shall demonstrate the ability to drain urine.
5 General requirements
5.1 Risk management
An established risk management process shall be applied to the design of the device.
Compliance shall be checked by inspection of the risk management file verifying compliance to Iso 14971.
5.2 Biocompatibility
The device shall be free from biological hazard in accordance with appropriate testing under ISO 10993-1.
5.3 Detectability
The catheter or at least its effective length shall be detectable by X-ray or by other means (ultra-sound, M RI. etc.), if required by the risk assessment.
NOTE Such as ASTM F640 or DIN 13273-7.
5.4 Surface finish
When examined by normal or corrected to normal vision, the external surface of the effective length of the catheter shall appear free from:
— extraneous matter;
— process and surface defects that may present an unacceptable risk of patient harm.
If deemed necessary based on risk assessment, inspection shall be conducted under a minimum 2,5x
magnification.
5.5 Size designation
5.5.1 General
The nominal size of the catheter shall be designated as specified in £52.
5.5.2 Outer diameter
Unless otherwise specified in another clause of this document for a particular type of catheter, the outer diameter shall be expressed as the nominal dimension in millimetres, rounded upwards to the nearest 0,1 mm. Tolerances on this stated size shall be ±0,33 mm.
NOTE Additional units can also he given. French size (Fr, Ch, FG) is a nominal dimensional identification of the outer size of drainage catheters; calculated as three times the diameter (in millimetres): Fr = 3 x D (mm).
For devices which are not round by design, the size shall be designated by the dimension of the largest axis. Where relevant, manufacturers may choose to report additional information regarding the device profile, such as the dimension of the second axis for an oval shape.
The balloon capacity shall be expressed in millilitres.BS EN ISO 20696 pdf download.
