Sterile drainage catheters and accessory devices for single use

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

06-05-2018

Publisher

International Organization for Standardization

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.

Committee	ISO/TC 84
DevelopmentNote	Supersedes ISO/DIS 20697. (06/2018)
DocumentType	Standard
Pages	38
ProductNote	THIS STANDARD ALSO REFERS TO ISO 20695 THIS STANDARD HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH 2018
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
UNE-EN ISO 20697:2019	Identical
SN EN ISO 20697 : 2019	Identical
DIN EN ISO 20697 E : 2019	Identical
NF EN ISO 20697 : 2018	Identical
DIN EN ISO 20697:2019-04	Identical
I.S. EN ISO 20697:2018	Identical
SS-EN ISO 20697 : 2018	Identical
EN ISO 20697:2018	Identical
ÖNORM EN ISO 20697: 2019 02 01	Identical
I.S. EN ISO 20697:2018&LC:2018	Identical
IS 18451 : 2023	Identical

DIN 13273-7:2003-08	CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 1842 : 2015 : REDLINE	Standard Test Method for Determining Ink or Coating Adhesion on Flexible Substrates for a Membrane Switch or Printed Electronic Device
ISO/TR 19244:2014	Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
ISO 14630:2012	Non-active surgical implants General requirements
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ASTM F 2052 : 2015 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F 2213 : 2017 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 80369-1:2010	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
ASTM F 1828 : 2017 : REDLINE	Standard Specification for Ureteral Stents
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008	Symbols for use in the labelling of medical devices
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use