ISO 10555-3:2013

Overview

ISO 10555-3:2013 - "Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters" is an International Organization for Standardization (ISO) standard that specifies safety, performance and information requirements for central venous catheters supplied in the sterile condition and intended for single use. This second edition (2013) is part of the ISO 10555 series overseen by ISO/TC 84 (devices for administration of medicinal products and intravascular catheters).

Key topics and technical requirements

The standard focuses on specific product features and testing requirements for central venous catheters, building on the general rules in ISO 10555-1. Principal technical topics include:

• Scope and definitions
  • Applies to single- or multilumen central venous catheters designed for introduction into or withdrawal from the central venous system.
• Reference to general requirements
  • Catheters shall comply with ISO 10555-1 except where this part specifies different requirements (notably peak tensile force).
• Distance markings
  • If provided, markings must indicate distance from the distal end.
  • Distance between marks shall not exceed 5 cm; recommended 1 cm spacing on clinically critical portions to aid positioning and migration monitoring.
• Lumen markings
  • Multilumen catheters must have lumen identification apparent to the user.
• Peak tensile force (soft tips)
  • For tips of softer durometer or different construction up to 20 mm long, minimum peak tensile force is specified by catheter outer diameter:
    • ≥0.55 and <0.75 mm: 3 N
    • ≥0.75 and <1.85 mm: 4 N
    • ≥1.85 mm: 5 N
  • Testing is performed per ISO 10555-1:2013 Annex B.
• Manufacturer information
  • Required labeling and documentation must include: distance-marking description (if applicable), flow rate for each lumen, maximum guidewire diameter (if applicable), warning against withdrawing the catheter through the needle, and at least one recommended cleaning agent.

Applications and users

ISO 10555-3 is used by:

• Medical device manufacturers for design, testing and product labeling of central venous catheters.
• Quality and regulatory teams preparing technical files and CE or other regulatory submissions.
• Test laboratories and notified bodies conducting mechanical and labeling compliance testing.
• Clinical procurement specialists and hospitals when specifying sterile, single-use central venous catheters.
• Biomedical engineers and risk managers validating device performance and safety.

Related standards

• ISO 10555-1:2013 - General requirements for sterile, single-use intravascular catheters
• ISO 11070 - Sterile, single-use intravascular catheter introducers
• Other parts of ISO 10555 (Part 4: balloon dilatation catheters; Part 5: over-needle peripheral catheters; Part 6 under preparation)

Keywords: ISO 10555-3, central venous catheters, intravascular catheters, sterile and single-use catheters, peak tensile force, distance markings, lumen markings, medical device standards.