ISO 10555-6:2015
Current
The latest, up-to-date edition.
Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
15-04-2015
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 |
ISO/TC 84
|
| DevelopmentNote |
Supersedes ISO/DIS 10555-6. (04/2015) NEW CHILD CREATE AMD1
|
| DocumentType |
Standard
|
| Pages |
17
|
| ProductNote |
NEW CHILD CREATE AMD1
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 10555-6 : 2017 | Identical |
| DIN EN ISO 10555-6:2017-11 | Identical |
| I.S. EN ISO 10555-6:2017 | Identical |
| NEN EN ISO 10555-6 : 2017 | Identical |
| PN EN ISO 10555-6 : 2017 | Identical |
| NS EN ISO 10555-6 : 2017 | Identical |
| ONORM EN ISO 10555-6 : 2017 | Identical |
| SS-EN ISO 10555-6:2017 | Identical |
| EN ISO 10555-6:2017 | Identical |
| BS EN ISO 10555-6:2017 | Identical |
| IS 18292 : Part 6 : 2023 | Identical |
| UNE-EN ISO 10555-6:2018 | Identical |
| NF ISO 10555-6 : 2015 | Identical |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| 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 48:2010 | Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| 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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