ISO 10555-6-2015 PDF

Full title and description

ISO 10555-6:2015 — Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports. This part of ISO 10555 specifies requirements, performance tests, user safety considerations and information for subcutaneous implanted ports and associated catheters supplied sterile and intended for single use.

Abstract

ISO 10555-6:2015 defines essential design, construction, testing and labelling requirements for implantable subcutaneous ports and their connected catheters used for long‑term intravascular therapy. It addresses biocompatibility, septum performance (puncture and resealing), leakage, connection strength, flow and burst pressure, labelling and information for safe use. The part does not specify requirements for non‑coring needles.

General information

• Status: Published (International Standard; reviewed and confirmed in periodic review cycles).
• Publication date: April 2015 (first edition — often shown as 15 April 2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (medical and surgical equipment).
• Edition / version: Edition 1 (2015). Amendment(s) published subsequently (ISO 10555-6:2015/Amd 1:2019).
• Number of pages: 17 pages (English original).

Scope

This part of ISO 10555 specifies requirements and test methods applicable to subcutaneous implanted ports and the catheters connected to them when supplied sterile for single use and intended for intravascular long‑term applications. It covers physical and performance requirements, user safety considerations, labelling and information to be supplied by the manufacturer. It does not cover the design or testing of non‑coring needles used to access ports. Compliance with the general requirements of ISO 10555‑1 is assumed unless differing requirements are given in this part.

Key topics and requirements

• Biocompatibility: devices shall be free from biological hazards and be evaluated in accordance with ISO 10993‑1 principles.
• Septum performance: penetration and withdrawal forces, resealability, and resistance to repeated punctures are specified and tested.
• Leakage and integrity: leakage tests and acceptance criteria (including pressure test criteria) for port chamber and connections.
• Connection strength: minimum tensile strength and mechanical requirements for port–catheter connections.
• Fluid performance: flow‑rate verification versus manufacturer claims and burst pressure requirements; special provisions for devices intended for power injection.
• Surface finish and radio‑detectability: requirements for visual inspection, surface cleanliness and radiopaque/radio‑detectable features consistent with ISO 10555‑1.
• Labelling and instructions for use: mandatory markings, traceability, sterile packaging information and port‑specific user instructions.
• MRI and electromagnetic considerations: evaluation of hazards and compatibility in MR environments using appropriate test methods (referenced test standards identified).

Typical use and users

Primary users include medical device manufacturers designing and validating implantable ports and associated catheters, independent testing laboratories performing mechanical and fluid performance tests, regulatory and notified bodies assessing conformity documentation, and clinical procurement or biomedical engineering teams in hospitals evaluating device suitability for chemotherapy, long‑term infusion and, where applicable, power injection.

Related standards

Standards commonly referenced alongside ISO 10555‑6 include ISO 10555‑1 (general requirements for sterile single‑use intravascular catheters), other parts of ISO 10555 (for central venous and peripheral catheter types), ISO 10993‑1 (biological evaluation of medical devices), ISO 11070 (introducers, dilators and guidewires) and ASTM test methods for MR safety and electromagnetic evaluation where noted.

Keywords

intravascular catheter, subcutaneous implanted port, implanted port, port‑a‑cath, sterile single‑use catheter, septum, leakage, burst pressure, biocompatibility, ISO 10555, medical device standard.

FAQ

Q: What is this standard?

A: ISO 10555‑6:2015 is the part of the ISO 10555 series that specifies requirements for subcutaneous implanted ports and their connected catheters when supplied sterile for single use and intended for long‑term intravascular therapy.

Q: What does it cover?

A: It covers design and performance requirements, test methods (leakage, septum puncture and reseal, tensile connection strength, flow and burst pressure), labelling and information for safe use, and biocompatibility expectations. It does not specify requirements for non‑coring needles.

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, regulatory reviewers and hospital clinical/biomedical staff involved in selection, testing or oversight of implantable port systems.

Q: Is it current or superseded?

A: The 2015 edition is the published first edition. The standard has been subject to an amendment (AMD 1:2019) and, according to ISO lifecycle records, was reviewed and confirmed in a subsequent review (confirmation noted in ISO metadata). Users should consult the issuing body for any later amendments or revisions beyond 2019.

Q: Is it part of a series?

A: Yes — ISO 10555 is a multi‑part series covering sterile, single‑use intravascular catheters; Part 6 addresses subcutaneous implanted ports specifically and references general requirements in ISO 10555‑1 and other parts as applicable.

Q: What are the key keywords?

A: Subcutaneous implanted port, port chamber, septum, catheter, biocompatibility, leakage test, burst pressure, flow rate, labelling, single‑use sterile device.