ISO 10555-4-2023 PDF
Name in English:
St ISO 10555-4-2023
Name in Russian:
Ст ISO 10555-4-2023
Original standard ISO 10555-4-2023 in PDF full version. Additional info + preview on request
Full title and description
ISO 10555-4:2023 — Intravascular catheters — Sterile and single‑use catheters — Part 4: Balloon dilatation catheters. This International Standard specifies safety, design and testing requirements for sterile, single‑use balloon dilatation (angioplasty) catheters intended for intravascular use.
Abstract
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. It does not cover requirements for vascular stents (see ISO 25539‑2). Guidance on selection of balloon materials is provided in Annex G.
General information
- Status: Published (current International Standard).
- Publication date: 14 November 2023 (ISO edition published November 2023).
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 11.040.25 (Syringes, needles and catheters).
- Edition / version: Edition 3 (2023).
- Number of pages: 17 pages in the ISO PDF edition (note: some adopted national/EN versions include additional national front matter and show larger page counts, e.g., BS EN edition shown with 26 pages).
Scope
Specifies requirements, test methods and marking/labeling requirements for sterile, single‑use balloon dilatation catheters for intravascular use. The standard covers dimensional, mechanical and performance characteristics (including inflation/deflation behaviour, burst/leak tests and balloon material guidance) and requirements for packaging and instructions for use. It explicitly excludes requirements for vascular stents (refer ISO 25539‑2).
Key topics and requirements
- Designation and intended use, including size coding and labelling requirements.
- Dimensional and material requirements for shafts, hubs and balloons; guidance on balloon material selection (Annex G).
- Sterility, packaging and shelf‑life considerations for single‑use devices.
- Mechanical and performance tests: leak tests, burst pressure, inflation/deflation characteristics and physical testing.
- Labelling, instructions for use and safety information to support correct clinical application.
- Exclusions and cross‑references to related device standards (e.g., vascular stents standards).
Typical use and users
Primary users include medical device manufacturers (design, production and quality teams), product testing laboratories, regulatory and compliance professionals, hospital procurement and clinical engineering departments, and clinicians involved in interventional cardiology/vascular procedures. The standard is used to demonstrate conformance to recognized performance and safety criteria for balloon dilatation catheters.
Related standards
Notable related standards and references include ISO 25539‑2 (vascular stents — referenced as excluded subject matter), ISO 10993 series (biocompatibility evaluation), ISO 13485 (medical devices — quality management) and regional/adopted standards such as EN ISO 10555‑4 (national/EN adoption of the same content).
Keywords
balloon dilatation catheter, intravascular catheter, angioplasty balloon, sterile, single‑use, ISO 10555‑4, catheter testing, burst pressure, leak test, labelling, Annex G (balloon materials).
FAQ
Q: What is this standard?
A: ISO 10555‑4:2023 is an International Standard that defines requirements and test methods for sterile, single‑use balloon dilatation (angioplasty) catheters used intravascularly.
Q: What does it cover?
A: It covers design, materials, dimensional and performance requirements, sterility and packaging, labelling and instructions for use, and specified mechanical and functional tests (e.g., leak/burst and inflation/deflation behaviour). It does not set requirements for vascular stents (see ISO 25539‑2).
Q: Who typically uses it?
A: Device manufacturers, test laboratories, regulatory affairs professionals, hospital procurement, and clinicians involved in interventional procedures use this standard to develop, test and assess balloon dilatation catheters.
Q: Is it current or superseded?
A: Current. ISO 10555‑4:2023 (Edition 3) is the published replacement for ISO 10555‑4:2013.
Q: Is it part of a series?
A: Yes. ISO 10555 is a multi‑part series covering sterile and single‑use intravascular catheters (other parts cover different catheter types and requirements). Part 4 specifically addresses balloon dilatation catheters.
Q: What are the key keywords?
A: Balloon dilatation catheter, intravascular catheter, sterile, single‑use, angioplasty, burst pressure, leak test, labelling, ISO 10555‑4.