I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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)
Hardcopy , PDF
19-11-2019
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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National Foreword
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
Defines 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.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 10555-6:2017 | Identical |
| ISO 10555-6:2015 | 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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