BS EN ISO 20696:2018,Sterile urethral catheters for single use.Now you can download BS EN ISO 20696:2018 pdf here.
Guidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.
This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This document does not include drainage catheters covered by 150 20697, e.g. ureteral catheters,nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
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, MRI, ete. ) if required by the risk assessment.