Sterile drainage catheters and accessory devices for single use

Sterile drainage catheters and accessory devices for single use

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£246.00
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1   Scope

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:
  1. a) suction catheters;
  2. b) tracheal catheters;
  3. c) urethral catheters;

    NOTE See ISO 20696.

  4. d) ureteral stents, biliary stents, and other stents;

    NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements.

  5. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
  6. f) neuraxial catheters used for removal of cerebrospinal fluid;

    NOTE See ISO 20698.

  7. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract;

    NOTE See ISO 20695.

  8. h) coatings.