EN ISO 10555-6:2017

Name: EN ISO 10555-6:2017
Brand: CEN

Superseded

View Superseded by

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

Superseded date

07-02-2020

Published date

23-08-2017

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements of the implantable subcutaneous
  implanted port and catheter
5 Magnetic Resonance Imaging (MRI) compatibility
6 Information to be supplied by the manufacturer
Annex A (normative) - Test method for freedom from
        air leakage
Annex B (informative) - Determination of flushing volume
Annex C (informative) - Guidance on further characterization
        testing: Needle penetration and withdrawal
Annex D (normative) - Test method for freedom from leakage
        after multiple punctures
Annex E (normative) - Peak tensile force
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

Committee	CEN/TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 10555-6:2017/A1:2019

Standards	Relationship
DIN EN ISO 10555-6:2017-11	Identical
NF EN ISO 10555-6 : 2017	Identical
I.S. EN ISO 10555-6:2017	Identical
NEN EN ISO 10555-6 : 2017	Identical
ONORM EN ISO 10555-6 : 2017	Identical
DIN EN ISO 10555-6 E : 2017	Identical
SN EN ISO 10555-6:2017	Identical
UNE-EN ISO 10555-6:2018	Identical
NS EN ISO 10555-6 : 2017	Identical
BS EN ISO 10555-6:2017	Identical
UNI EN ISO 10555-6 : 2018	Identical
ISO 10555-6:2015	Identical
SS-EN ISO 10555-6:2017	Identical
PN EN ISO 10555-6 : 2017	Identical
UNI EN ISO 10555-6:2020	Identical

ISO 5832-1:2016	Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
EN ISO 10555-3:2013	Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 9584:1993	Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
ISO 6474-1:2010	Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
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 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10555-3:2013	Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
ISO 5832-2:1999	Implants for surgery Metallic materials Part 2: Unalloyed titanium
ISO 10555-1:2013	Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 80369-7:2016	Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 48:2010	Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices