EN ISO 10555-4:2023 PDF

Name: EN ISO 10555-4:2023 — Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
SKU: EN ISO 10555-4:2023
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Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)

Название (английский):

EN ISO 10555-4:2023

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 25
Дата публикации:: 29 ноября 2023 г.
Издание:: CEN EN 10555 edition 2 version 1
ICS:: 11.040.25

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Описание (английский):

This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. This document does not specify requirements for vascular stents (see ISO 25539-2). NOTE Guidance on the selection of balloon materials is given in Annex G.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 10555-4:2023 - “Intravascular catheters - Sterile and single‑use catheters - Part 4: Balloon dilatation catheters” specifies essential requirements and test methods for sterile, single‑use balloon dilatation catheters. Endorsed by CEN in November 2023 and published as ISO 10555-4:2023, this part of the ISO 10555 series replaces the 2013 edition and focuses on performance, safety and labelling specific to balloon catheters used to dilate vascular lesions. Annex G provides guidance on balloon material selection.

Key topics and technical requirements

Scope and definitions

Defines a balloon dilatation catheter, balloon rated burst pressure (RBP), crossing profile and effective balloon length.

Designations and labelling

Required nominal size details: inflated balloon diameter, effective balloon length, maximum compatible guidewire diameter and minimum inner diameter of introducer/guide/sheath.

Detectability

Balloon position must be detectable by X‑ray or other imaging (ultrasound, MRI); test methods such as ASTM F640-20 or DIN 13273-7 are referenced.

Physical performance tests (normative annexes)

RBP (Annex A): Determine balloon rated burst pressure.
Fatigue/leakage (Annex B): Verify freedom from leakage or damage after repeated inflation cycles (default 10 cycles or a clinically justified alternative).
Deflation time (Annex C): Measure time to deflate from RBP.
Balloon compliance (Annex D): Relationship between balloon diameter and inflation pressure.
Crossing profile (Annex E): Measure maximum outer diameter between proximal balloon bond and distal tip.
Balloon removal (Annex F): Demonstrate safe removal after inflation/deflation without damage.

Information to be supplied

Conforms with ISO 10555-1 requirements plus the additional balloon‑specific data above.

Practical applications and who uses the standard

Medical device manufacturers use EN ISO 10555-4:2023 to design, validate and document balloon dilatation catheters for regulatory submissions and CE marking.

Quality, R&D and regulatory teams use the test methods for bench validation and risk assessments.

Clinical engineers, procurement and hospitals rely on standardized labelling and performance claims to select compatible introducers, guidewires and delivery systems.

Notified bodies and regulators use the standard as a reference for conformity assessment of sterile single‑use balloon catheters.

Related standards

ISO 10555-1:2023 - General requirements for sterile single‑use intravascular catheters

ISO 25539-2 - Vascular stent systems (not covered by this document)

Test references: ASTM F640-20, DIN 13273-7

EN ISO 10555-4:2023 is a practical, test‑focused standard that helps ensure the safety, compatibility and documented performance of balloon dilatation catheters across design, manufacturing and clinical use.

EN ISO 10555-4:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses the standard

Related standards

Технические детали

ISO 10555-4:2023

Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

ISO 10555-1:2023

Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

BS EN ISO 10555-1:2023

Intravascular catheters. Sterile and single-use catheters. General requirements.

SIST EN ISO 25539-2:2020

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)