ISO 10555-6-2015 amd1-2019 PDF

Full title and description

ISO 10555-6:2015/Amd 1:2019 — Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports — Amendment 1. This entry refers to the 2015 Part 6 standard for sterile, single‑use subcutaneous implanted ports together with Amendment 1 published in 2019, which updates or clarifies specific requirements of the 2015 edition.

Abstract

ISO 10555-6:2015 specifies requirements, performance criteria and user‑safety considerations for subcutaneous implanted ports and associated catheters intended for long‑term intravascular use, supplied sterile and intended for single use. Amendment 1 (2019) provides changes to the original 2015 text (see amendment text for details). The standard does not specify requirements for non‑coring needles.

General information

• Status: Published.
• Publication date: Main standard published April 2015 (valid from 15 April 2015); Amendment 1 published September 2019.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (2015) with Amendment 1 (2019).
• Number of pages: Main document 17 pages; Amendment 1 = 1 page (often sold/packaged together as standard + amendment).

Scope

This part of ISO 10555 applies to sterile, single‑use subcutaneous implanted ports and associated catheters intended for long‑term intravascular access. It specifies performance requirements, testing and safety considerations for design, manufacture and labelling of these devices. The document explicitly excludes requirements for non‑coring needles. Amendment 1 modifies or clarifies selected provisions of the 2015 edition — refer to the amendment text for exact changes.

Key topics and requirements

• Design and construction requirements for subcutaneous implanted ports and attached catheters (materials, dimensions, connectors and mechanical integrity).
• Performance testing (leakage, flow characteristics, pressure/durability tests and device integrity under simulated use).
• User safety and biocompatibility considerations, including infection prevention and handling of sterile, single‑use devices.
• Labelling, packaging and sterility requirements appropriate for single‑use implanted ports.
• Any specific amendments or clarifications introduced by Amendment 1 (2019) — see amendment text for the exact editorial or technical changes.

Typical use and users

Used to specify requirements during design, manufacture, testing and regulatory submission of subcutaneous implanted ports for long‑term intravascular access. Typical users include medical device manufacturers, quality and regulatory affairs professionals, test laboratories, healthcare procurement teams, and regulatory agencies or notified bodies assessing compliance. Clinicians and hospital technical staff may consult the standard to understand device performance and safety expectations.

Related standards

ISO 10555 is a multi‑part series covering sterile, single‑use intravascular catheters. 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). (Part 2 was withdrawn and its content incorporated into ISO 10555‑1). See the ISO 10555 series for full relations and cross‑references.

Keywords

intravascular catheter; subcutaneous implanted port; implanted port; single‑use; sterile; ISO 10555; amendment 2019; medical device standard; long‑term intravascular access.

FAQ

Q: What is this standard?

A: ISO 10555‑6:2015 is the International Standard that specifies requirements and performance criteria for sterile, single‑use subcutaneous implanted ports and their catheters for long‑term intravascular use. Amendment 1 (2019) updates or clarifies parts of the 2015 edition.

Q: What does it cover?

A: It covers design, performance testing, labelling and user safety considerations for subcutaneous implanted ports supplied sterile and intended for single use; it does not define requirements for non‑coring needles. For the exact test methods and limits, consult the full standard and the text of Amendment 1.

Q: Who typically uses it?

A: Medical device manufacturers, product development teams, quality and regulatory professionals, testing laboratories, health‑care procurement and clinical engineering staff, and regulatory reviewers use this standard as a technical and compliance reference.

Q: Is it current or superseded?

A: The original ISO 10555‑6 edition was published in April 2015 and Amendment 1 was published in September 2019. ISO’s record shows the 2015 edition (with its amendment) was reviewed and confirmed in 2025, indicating the document remains current according to ISO’s 5‑year review cycle; users should check ISO or their national standards body for any newer revisions after 2025.

Q: Is it part of a series?

A: Yes — ISO 10555 is a multi‑part series addressing sterile, single‑use intravascular catheters; Part 6 addresses subcutaneous implanted ports while other parts cover general requirements and other catheter types.

Q: What are the key keywords?

A: intravascular catheter; subcutaneous implanted port; implanted port; sterile single‑use; device performance; labelling; biocompatibility; ISO 10555‑6; amendment 2019.