Standard

NS-EN ISO 20697:2018

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Abstract

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; b) tracheal catheters; c) urethral catheters; NOTE See ISO 20696. d) ureteral stents, biliary stents, and other stents; NOTE See ISO 14630 and ASTM F1828-97 for stents requirements. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; NOTE See ISO 20698. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; NOTE See ISO 20695. h) coatings.

Document information

  • Standard from SN
  • Published:
  • Edition: 2018-07
  • Version: 1
  • Document type: NAT
  • ICS 11.040.25
  • National Committee CEN/TC 205

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EU law: 93/42/EEC

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