ISO 10555-5-2013 PDF

Full title and description

ISO 10555-5:2013 — Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters. This international standard specifies design, material, performance and information requirements for over-needle peripheral intravascular catheters supplied sterile and intended for single use, including requirements that apply to the catheter unit and its introducer needle/hub.

Abstract

Defines requirements for over-needle peripheral intravascular catheters used to access the peripheral vascular system. Covers physical design, material and needle requirements, performance tests, labelling and information the manufacturer must supply for safe use. The standard focuses on single‑use sterile devices and on the catheter/needle interface and introducer components.

General information

• Status: Published; edition confirmed current following periodic review (confirmed 2023).
• Publication date: June 2013 (Edition 2, 2013).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 2 (2013).
• Number of pages: 10 pages (typical PDF length for the ISO edition).

Scope

Specifies requirements applicable to over‑needle peripheral intravascular catheters (catheter units supplied with an introducer needle) intended to access the peripheral vascular system. Requirements address materials, needle tubing and tip geometry, catheter/needle fit, colour coding of hubs or fittings, necessary performance tests (mechanical and leakage tests), and the information and warnings that manufacturers must supply with the product. The standard applies to sterile, single‑use devices only.

Key topics and requirements

• Terminology and definitions for catheter unit components (catheter, needle tube, hub, flashback, vent fitting).
• Material and needle requirements — needle tubing materials and dimensional/finish expectations (e.g., reference to stainless‑steel needle tubing standards where applicable).
• Needle‑point geometry and inspection criteria (sharp, burr‑free, and designed to be non‑coring under magnification).
• Catheter distal‑end geometry and catheter/needle fit tolerances (requirements for how the catheter fits on the needle when fully assembled).
• Colour coding of hubs/fittings to indicate nominal outside diameter (with specified coding table).
• Performance tests, for example tensile/union strength of needle hub/tube, vent fitting leakage tests and other mechanical tests described in annexes.
• Required manufacturer information on packaging/leaflet: nominal dimensions, warnings (e.g., do not reinsert withdrawn needle), flow rates, colour code and sterilization information.

Typical use and users

Used by manufacturers and product designers of intravascular peripheral catheters to establish design and test criteria; by quality and regulatory teams to demonstrate conformity for market approval; and by hospital procurement, clinical engineers and clinicians (nurses, physicians) as a reference for product selection and safety expectations. Regulatory reviewers and notified bodies also use the standard as part of conformity assessment for peripheral catheter devices.

Related standards

Part of the ISO 10555 series (requirements for sterile, single‑use intravascular catheters). Related documents and references commonly cited with this part include other parts of ISO 10555 (other catheter types), ISO 9626 for stainless steel needle tubing properties where applicable, and connector/compatibility standards such as ISO 80369 series for small‑bore connectors. National and regional adoptions (EN ISO versions) also exist.

Keywords

intravascular catheter, over‑needle, peripheral catheter, introducer needle, single‑use, sterile, catheter unit, colour coding, ISO 10555, medical device standard.

FAQ

Q: What is this standard?

A: ISO 10555-5:2013 is an international standard that sets design, material, performance and information requirements for over‑needle peripheral intravascular catheters that are supplied sterile and intended for single use.

Q: What does it cover?

A: It covers terminology, material and needle requirements, catheter and needle design/interface, mechanical and leakage performance tests, colour coding of fittings, and the information manufacturers must supply with the device (labelling, warnings, dimensions, flow data).

Q: Who typically uses it?

A: Medical device manufacturers (design and quality teams), regulatory reviewers and notified bodies, clinical procurement and hospital/device users (clinicians, nurses), and test laboratories. It is used to support product specifications, conformity assessment and informed product selection.

Q: Is it current or superseded?

A: The 2013 edition (Edition 2) is the published version; ISO has recorded a periodic review (confirmed 2023) keeping this edition current while a revision process (Draft/Dis) has been documented for a future replacement. Users should check the national/ISO catalog for any published replacement after 2013 before relying on the standard for certification.

Q: Is it part of a series?

A: Yes — ISO 10555 is a multi‑part series covering sterile, single‑use intravascular catheters (different parts address different catheter types and use cases); Part 5 specifically addresses over‑needle peripheral catheters.

Q: What are the key keywords?

A: Over‑needle peripheral catheter, introducer needle, catheter unit, single‑use, sterile, colour coding, catheter/needle fit, performance testing.