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.
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Sisällysluettelo
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements of the implantable subcutaneous implanted port and catheter
4.1 General
4.2 Biocompatibility
4.3 Distance markings
4.4 Nominal dimensions of the subcutaneous implanted port
4.5 Physical requirements
4.6 Flow rate
4.7 Burst pressure of the subcutaneous implanted port and catheter
5 Magnetic Resonance Imaging (MRI) compatibility
6 Information to be supplied by the manufacturer
6.1 Marking on the device
6.2 Primary packaging
6.3 Labels for traceability
6.4 Instruction for use
Annex A Test method for freedom from air leakage (normative)
Annex B Determination of flushing volume (informative)
Annex C Guidance on further characterization testing: Needle penetration and withdrawal (informative)
Annex D Test method for freedom from leakage after multiple punctures (normative)
ISO 10555-1:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements
ISO 10555-3:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
ISO 10555-1:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements
ISO 10555-3:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters