ISO 10555-4:2023

Overview

ISO 10555-4:2023 - "Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters" is an international standard that specifies requirements and test methods for sterile, single‑use balloon dilatation catheters. It defines essential performance and labelling requirements (e.g., detectability, balloon rated burst pressure, compliance, deflation time and crossing profile) and lists mandatory test procedures in normative annexes. Annex G provides informative guidance on balloon material selection.

Key Topics and Requirements

• Scope: Applies to sterile, single‑use intravascular balloon dilatation catheters; excludes vascular stent requirements (see ISO 25539-2).
• Detectability: Balloon position must be detectable by X‑ray or other means (ultrasound, MRI); demonstrable by an appropriate test (e.g., ASTM F640-20 or DIN 13273-7).
• Designation / Labelling: Nominal size must include balloon diameter(s), effective balloon length, largest compatible guidewire diameter and minimum inner diameter of compatible introducer/guide/sheath.
• Physical performance:
  • Balloon Rated Burst Pressure (RBP) - determined per Annex A; burst mode and location reported.
  • Fatigue / Leakage - balloon must withstand repeated inflation cycles (default 10 cycles to RBP) with no leakage or damage (Annex B). Alternative cycle counts allowed if clinically justified and risk‑assessed.
  • Deflation Time - measured from RBP using Annex C.
  • Balloon Compliance - relationship of diameter to inflation pressure (Annex D).
  • Crossing Profile - maximum outer diameter between balloon proximal end and distal tip; measured via Annex E.
  • Balloon Removal - demonstration that balloon can be removed without damage after inflation/deflation (Annex F).
• Information to be supplied: Must include RBP (kPa), inflation pressure to reach nominal diameter (kPa), marker positions, compatibility recommendations, and nominal size details.

Applications and Who Uses This Standard

ISO 10555-4:2023 is used by:

• Manufacturers of balloon angioplasty and dilatation catheters for product design, verification and labelling.
• Test laboratories performing bench testing and conformity assessment against normative annexes.
• Regulatory and quality teams to demonstrate compliance for market approval and technical files.
• Procurement and clinical engineers who need specified performance data (RBP, compatibility, deflation time, crossing profile) for device selection.
• Standards authors and risk assessors assessing material selection and performance claims (Annex G guidance).

Related Standards

• ISO 10555-1:2023 - General requirements for sterile, single‑use intravascular catheters.
• ISO 25539-2 - Requirements for vascular stent systems (stent-specific guidance).
• Test references cited: ASTM F640-20, DIN 13273-7 (for marker/detectability testing).

Keywords: ISO 10555-4:2023, balloon dilatation catheters, intravascular catheters, rated burst pressure, balloon compliance, crossing profile, sterile single‑use catheters, medical device testing.