Verkkokauppa
SFS-EN ISO 20697:2018:en
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
Tekninen komitea
Direktiivi
Vahvistuspäivä
03.08.2018
Julkaisupäivä
07.08.2018
Painos
1
Sivumäärä
41
Julkaisun kieli
englanti