ISO 10555-8-2024 PDF

Full title and description

ISO 10555-8:2024 — Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment. This part of ISO 10555 provides requirements specific to intravascular catheters intended for extracorporeal blood treatments (EBT).

Abstract

This document specifies general requirements for intravascular catheters, supplied in sterile condition and intended for extracorporeal blood treatments (EBT).

General information

• Status: Published.
• Publication date: 17 August 2024 (ISO publication: 2024-08).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (2024).
• Number of pages: 12 pages (ISO bibliography lists 12 pages).

Scope

ISO 10555-8:2024 sets out the general requirements that apply to sterile, single‑use intravascular catheters intended for extracorporeal blood treatments (EBT). The scope focuses on product requirements and test methods needed to ensure safety, sterility on delivery, and suitability for blood‑contacting extracorporeal applications.

Key topics and requirements

• Intended use: catheters designed specifically for extracorporeal blood treatments (EBT).
• Design and dimensional requirements to ensure compatibility with extracorporeal circuits and connectors.
• Materials and biocompatibility considerations for blood‑contacting components.
• Performance and mechanical tests relevant to extracorporeal use (e.g., flow, pressure and connection integrity).
• Sterility, packaging and labelling requirements for sterile, single‑use delivery.
• Normative references and relationship to the general requirements in ISO 10555‑1.

Typical use and users

Primary users include medical device manufacturers (design and compliance teams), regulatory and quality professionals, testing laboratories, procurement managers for hospitals and dialysis/EBT clinics, and clinical engineers involved in extracorporeal therapies. The standard is used during product design, pre‑market conformity assessment, supplier specifications, and procurement.

Related standards

ISO 10555-8 is part of the ISO 10555 series for sterile, single‑use intravascular catheters. Closely related parts include ISO 10555‑1 (General requirements), ISO 10555‑3 (Central venous catheters), ISO 10555‑4 (Balloon dilatation catheters), ISO 10555‑5 (Over‑needle peripheral catheters) and ISO 10555‑7 (Peripherally inserted central catheters). Part 2 (angiographic catheters) has been withdrawn and its content incorporated into the series where applicable.

Keywords

Intravascular catheter; sterile; single‑use; extracorporeal blood treatment; EBT; catheter requirements; biocompatibility; labelling; packaging; ISO 10555.

FAQ

Q: What is this standard?

A: ISO 10555-8:2024 is an international standard that specifies general requirements for sterile, single‑use intravascular catheters intended for extracorporeal blood treatments (EBT).

Q: What does it cover?

A: It covers product‑level requirements relevant to catheters used in EBT, including scope of application, design considerations, performance/testing aspects, sterility and labelling expectations, and references to the series' general requirements.

Q: Who typically uses it?

A: Manufacturers, regulatory and quality assurance teams, testing laboratories, clinical engineering, and hospital procurement and clinical staff involved with extracorporeal therapies and vascular access.

Q: Is it current or superseded?

A: ISO 10555-8:2024 is the current published edition (first edition, published August 2024). It is not superseded as of its publication date.

Q: Is it part of a series?

A: Yes — it is Part 8 of the ISO 10555 series (Intravascular catheters — Sterile and single‑use catheters), which also includes Part 1 (general requirements) and several device‑specific parts.

Q: What are the key keywords?

A: Intravascular catheter, extracorporeal blood treatment (EBT), sterile, single‑use, biocompatibility, labelling, packaging, ISO 10555.