DIN EN ISO 20697 – Sterile drainage catheters and accessory devices for single use

This standard describes specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components. The drainage catheter is left to drain naturally or connected to a suction source. The test methods included in the standard are:

• Annex A: Test method for determining kink stability
• Annex B: Test method for corrosion resistance
• Annex C: Test method for resistance to deformation by suction
• Annex D: Test method for determining peak tensile force of connections
• Annex E: Test method for determining peak tensile force of drainage catheter
• Annex F: Test method for impact resistance of collection device
• Annex G: Test method for determination of flow rate through drainage catheter
• Annex H: Test method for retention strength
• Annex I: Test method for determining balloon safety
• Annex J: Test method for determining inflation lumen leakage and /or function and/or balloon deflation (drainage catheter with compliant balloon)
• Annex K: Test method for determining balloon size and deflation reliability (drainage catheter with non-compliant balloon)
• Annex L: Test method for determining inflated balloon resistance to traction
• Annex M: Test method for resistance to leakage during aspiration or vacuum