EN ISO 10555-6:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
07-02-2020
23-08-2017
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Superseded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 |
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 |
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 |
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