<p>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.</p>
<p>The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.</p>
<p>This document is not applicable to:</p>
<p>a) suction catheters;</p>
<p>b) tracheal catheters;</p>
<p>c) urethral catheters;</p>
<p>NOTE See ISO 20696.</p>
<p>d) ureteral stents, biliary stents, and other stents;</p>
<p>NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements.</p>
<p>e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;</p>
<p>f) neuraxial catheters used for removal of cerebrospinal fluid;</p>
<p>NOTE See ISO 20698.</p>
<p>g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract;</p>
<p>NOTE See ISO 20695.</p>
<p>h) coatings.</p>
Registration number (WIID)
68855
Scope
<p>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.</p>
<p>The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.</p>
<p>This document is not applicable to:</p>
<p>a) suction catheters;</p>
<p>b) tracheal catheters;</p>
<p>c) urethral catheters;</p>
<p>NOTE See ISO 20696.</p>
<p>d) ureteral stents, biliary stents, and other stents;</p>
<p>NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements.</p>
<p>e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;</p>
<p>f) neuraxial catheters used for removal of cerebrospinal fluid;</p>
<p>NOTE See ISO 20698.</p>
<p>g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract;</p>
<p>NOTE See ISO 20695.</p>
<p>h) coatings.</p>
