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Sterile urethral catheters for single use

Available format(s)

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

Language(s)

English, French

Published date

05-06-2018

Publisher

International Organization for Standardization

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This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.

This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.

NOTE Ureteral stents are covered in ASTM F1828‑97.

Committee	ISO/TC 84
DevelopmentNote	Supersedes ISO/DIS 20696. (06/2018)
DocumentType	Standard
Pages	0
ProductNote	THIS STANDARD HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH 2018
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
DS EN ISO 20696 : 2018	Identical
IS 18288 : 2023	Identical
SN EN ISO 20696:2019	Identical
UNE-EN ISO 20696:2019	Identical
DIN EN ISO 20696:2019-04	Identical
EN ISO 20696:2018	Identical
PN-EN ISO 20696:2018	Identical
NF EN ISO 20696 : 2018	Identical
ÖNORM EN ISO 20696 : 2019 02 01	Identical
UNI EN ISO 20696:2018	Identical
SS-EN ISO 20696:2018	Identical
DIN EN ISO 20696:2020-10	Identical
DIN EN ISO 20696:2018-10	Identical
NEN-EN-ISO 20696:2018 (Cor. 2020-03)	Identical
ÖNORM EN ISO 20696:2020 10 15	Identical
DIN EN ISO 20696 E:2020	Identical
I.S. EN ISO 20696:2018	Identical
I.S. EN ISO 20696:2018&LC:2018	Identical
BS EN ISO 20696:2018	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
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
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