ISO 20696:2018–Sterile urethral catheters for single use
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 ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828‑97.
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
- ISO 14971:—1, Medical devices — Application of risk management to medical devices
- ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 80369-1, Small bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
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