ISO 10555-1:2023
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.
This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$322.61 NZD
|
|
| HardCopy |
$362.61 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Risk approach
4.2 Usability engineering
4.3 Sterilization
4.4 Shelf life
4.5 Detectability
4.6 Biocompatibility
4.7 Surface
4.8 Corrosion resistance
4.9 Peak tensile force
4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
4.12 Hubs
4.13 Flowrate
4.14 Power injection burst pressure
4.15 Packaging system
4.16 Simulated use, kink and/or torque testing to consider depending on device design, intended use, and risk analysis
4.17 Coating integrity and/or particulate testing to consider depending on device design, intended use, and risk analysis
4.18 Distal tip stiffness testing to consider for neurovascular applications
5 Designation of nominal size
5.1 Nominal outside diameter
5.2 Nominal inside diameter
5.3 Nominal effective length
6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and/or primary packaging
6.3 Instructions for use
6.4 Marking on the secondary packaging
Annex A (normative) Test method for corrosion resistance
Annex B (normative) Method for determining peak tensile force
Annex C (normative) Test method for liquid leakage under pressure
Annex D (normative) Test method for air leakage into hub assembly during aspiration
Annex E (normative) Determination of flowrate through catheter
Annex F (normative) Test for burst pressure under static conditions
Annex G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection)
Annex H (informative) Units of measurement systems other than those specified in this document
Annex I (normative) Test method for air leakage under water
Annex J (informative) Rationale and guidance
Annex K (informative) Test methods for distal tip stiffness for neurovascular applications
Bibliography
Previous versions
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS IEC 60601.2.16:2015
Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment -
BS 1263-1:1989
Reusable hypodermic syringes for medical use., Specification for dimensions of all-glass and metal-and-glass syringes
-
BS 6196:1989
Specification for sterile epidural catheters and introducer needles for single use
-
BS EN 12439:1999
Sterile rectal catheters for single use
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Risk approach
4.2 Usability engineering
4.3 Sterilization
4.4 Shelf life
4.5 Detectability
4.6 Biocompatibility
4.7 Surface
4.8 Corrosion resistance
4.9 Peak tensile force
4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
4.12 Hubs
4.13 Flowrate
4.14 Power injection burst pressure
4.15 Packaging system
4.16 Simulated use, kink and/or torque testing to consider depending on device design, intended use, and risk analysis
4.17 Coating integrity and/or particulate testing to consider depending on device design, intended use, and risk analysis
4.18 Distal tip stiffness testing to consider for neurovascular applications
5 Designation of nominal size
5.1 Nominal outside diameter
5.2 Nominal inside diameter
5.3 Nominal effective length
6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and/or primary packaging
6.3 Instructions for use
6.4 Marking on the secondary packaging
Annex A (normative) Test method for corrosion resistance
Annex B (normative) Method for determining peak tensile force
Annex C (normative) Test method for liquid leakage under pressure
Annex D (normative) Test method for air leakage into hub assembly during aspiration
Annex E (normative) Determination of flowrate through catheter
Annex F (normative) Test for burst pressure under static conditions
Annex G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection)
Annex H (informative) Units of measurement systems other than those specified in this document
Annex I (normative) Test method for air leakage under water
Annex J (informative) Rationale and guidance
Annex K (informative) Test methods for distal tip stiffness for neurovascular applications
Bibliography