ISO 10555-3-2013 PDF

Full title and description

ISO 10555-3:2013 — Intravascular catheters — Sterile and single‑use catheters — Part 3: Central venous catheters. Specifies requirements for central venous catheters supplied in the sterile condition and intended for single use, including general performance, marking and testing obligations for manufacturers.

Abstract

This part of ISO 10555 establishes requirements and test methods specific to central venous catheters (single‑ and multi‑lumen) intended for use in the central venous system. It complements the general requirements for intravascular catheters given in ISO 10555‑1 and addresses aspects such as materials, biocompatibility, sterility, radiodetectability (where applicable), device marking and specific performance tests relevant to central venous use.

General information

• Status: Published (Edition 2 — confirmed current following 2018 review).
• Publication date: 6 June 2013 (ISO publication: 2013‑06). Note: some national/adopted versions (BSI, AENOR, etc.) show differing publication/adoption dates in 2013.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 — Syringes, needles and catheters.
• Edition / version: Edition 2 (2013).
• Number of pages: Sources vary — ISO metadata shows a short document entry (3 pages) while national/adopted copies and sellers commonly list the full standard as 13–14 pages (typical published PDF length). Users should consult the official ISO or national‑standards copy to confirm the exact page count for the purchased/pdf file.

Scope

ISO 10555‑3:2013 applies to central venous catheters — single‑use, sterile devices intended for infusion, withdrawal of fluids, or pressure/other measurements in the central venous system. The standard specifies design and construction considerations, required information to be supplied by the manufacturer (marking and labelling), and performance and test methods (in conjunction with ISO 10555‑1 where general test methods are given). It does not cover accessories that are covered by other standards.

Key topics and requirements

• Definitions and classification of central venous catheters (single‑ and multi‑lumen) and intended clinical use.
• Material and biocompatibility requirements — application of ISO 10993‑1 for biological evaluation.
• Sterility and single‑use requirements; instructions for use and labelling obligations.
• Mechanical and fluid‑performance tests (tensile/peak force, burst/leakage, flow rate assessments, connection strength and integrity).
• Radiodetectability where determined necessary by risk assessment and marking/colour‑coding or distance markings to assist clinical placement.
• Compatibility and connector requirements — referenced where applicable to small‑bore connector standards and related connector guidance.

Typical use and users

Primary users include medical device manufacturers (design, testing and regulatory submissions), independent testing laboratories, hospital procurement and clinical engineering teams, regulatory authorities, and clinicians (intensive care, anaesthesia, interventional medicine) who rely on device labelling and performance claims. The standard is used both to guide design/manufacture and to define compliance testing for market access and quality systems.

Related standards

ISO 10555‑3 is part of the ISO 10555 series of intravascular catheter standards. Closely related documents include ISO 10555‑1 (General requirements and test methods), ISO 10555‑4 (Balloon dilatation catheters), ISO 10555‑5 (Over‑needle peripheral catheters) and ISO 10555‑6 (Implanted ports and port systems). Other related standards and normative references commonly cited include ISO 10993‑1 (biological evaluation), ISO 80369‑7 (small‑bore connectors for intravascular applications) and ISO 11070 (introducers, guidewires and dilators) as applicable.

Keywords

ISO 10555‑3; central venous catheter; intravascular catheter; sterile; single‑use; catheter testing; biocompatibility; radiodetectable; labelling; catheter performance; ISO 10555 series.

FAQ

Q: What is this standard?

A: ISO 10555‑3:2013 is the ISO international standard that specifies requirements and test methods for central venous catheters supplied sterile and intended for single use.

Q: What does it cover?

A: It covers product definition, material/biocompatibility expectations, sterility and single‑use considerations, required labelling and instructions for use, and specific performance and test requirements for central venous catheters; it works together with ISO 10555‑1 for general test methods.

Q: Who typically uses it?

A: Device manufacturers, testing laboratories, hospital procurement and clinical engineering teams, regulatory bodies, and clinicians involved with central venous access.

Q: Is it current or superseded?

A: As published, ISO 10555‑3:2013 (Edition 2) was reviewed and confirmed in 2018 and is listed as the current edition on the ISO catalogue. A subsequent draft (ISO/DIS 10555‑3) has been registered indicating revision activity; users should check the official ISO or their national standards body to confirm whether a newer edition or adoption exists at the time of purchase or use. (Information checked against ISO metadata and DIS listing.)

Q: Is it part of a series?

A: Yes — ISO 10555 is a multipart series covering intravascular catheters; Part 1 covers general requirements and test methods and other parts cover peripheral, balloon and port systems. ISO 10555‑3 specifically addresses central venous catheters.

Q: What are the key keywords?

A: Central venous catheter, intravascular catheter, sterile, single‑use, catheter testing, biocompatibility, labelling, ISO 10555‑3, radiodetectability.