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BS EN ISO 20696:2018:2020 Edition

BS EN ISO 20696:2018:2020 Edition

$167.15

Sterile urethral catheters for single use

Published By Publication Date Number of Pages
BSI 2020 42
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Intended performance
5 General requirements
5.1 Risk management
5.2 Biocompatibility
5.3 Detectability
5.4 Surface finish
5.5 Size designation
5.5.1 General
5.5.2 Outer diameter
12 5.5.3 Effective shaft lengths
13 5.6 MRI compatibility
5.7 Connector
5.8 Sterilization
6 Specific requirements
6.1 Strength
6.2 Connector security
6.3 Balloon safety
6.4 Catheter inflation lumen integrity and volume maintenance
6.4.1 General
14 6.4.2 Compliant balloon
6.4.3 Non-compliant balloon
6.5 Flow rate
15 6.6 Corrosion resistance
6.7 Kink stability
6.8 Peak tensile force
6.9 Inflated balloon resistance to traction
16 7 Information to be supplied by the manufacturer
7.1 General
7.2 Marking on the device and/or packaging
7.3 Instructions for use
18 Annex A (normative) Test method for determining the strength of the catheter
22 Annex B (normative) Test method for determining the security of fit of the drainage funnel
24 Annex C (normative) Test method for determining balloon safety
26 Annex D (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation (catheter with compliant balloon)
28 Annex E (normative) Test method for determination of flow rate through catheter
30 Annex F (normative) Test method for corrosion resistance
31 Annex G (informative) Test method for determining kink stability
33 Annex H (normative) Test method for determining peak tensile force of urethral catheter
35 Annex I (normative) Test method for determining balloon size deflation reliability (catheter with non-compliant balloon)
37 Annex J (normative) Test method for determining inflated balloon resistance to traction
41 Bibliography

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BS EN ISO 20696:2018
$167.15