ISO 10555-7-2023 PDF

Full title and description

ISO 10555-7:2023 — Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters. This International Standard specifies general requirements and a test method for peripherally inserted central catheters (PICC) supplied in the sterile condition and intended for single use, for any application. It explicitly excludes intravascular catheter accessories (for example those covered by ISO 11070).

Abstract

This document sets out the scope, general requirements and at least one standardized test method for PICCs (peripherally inserted central catheters). It is intended to provide manufacturers, test laboratories and regulators with a concise set of requirements covering design, manufacture and performance verification for sterile, single‑use PICCs.

General information

• Status: Published.
• Publication date: 18 December 2023 (ISO publication: 2023‑12).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (2023‑12).
• Number of pages: 5 (ISO published PDF). Note: national adoptions or publisher reprints (for example some national bodies’ PDF/paper copies) may show additional front matter and different pagination.

Scope

Specifies general requirements and a test method for peripherally inserted central catheters (PICC) that are supplied sterile and intended for single use. The standard covers performance and testing aspects relevant to PICCs and excludes intravascular catheter accessories covered by separate standards (for example ISO 11070).

Key topics and requirements

• Definition and classification of PICC devices and intended use (peripherally inserted central catheters).
• General requirements for design and manufacture of sterile, single‑use PICCs (materials, biocompatibility considerations implied by ISO/medical-device practice).
• Specified test method(s) to verify performance characteristics relevant to PICCs (e.g., flow, strength, catheter integrity under defined test conditions).
• Requirements excluding accessories — accessories are covered by separate standards such as ISO 11070.
• Conformity and documentation expectations consistent with the ISO 10555 series and ISO/TC 84 device guidance.

Typical use and users

Used by medical device manufacturers (design and quality teams), test laboratories performing type or verification testing, regulatory affairs professionals preparing submissions, hospital procurement and clinical engineering teams assessing device specifications, and clinicians seeking standards-based device information for device selection and risk assessment. The standard is intended to support conformity assessment and product specifications for PICC devices.

Related standards

ISO 10555-7 is part of the multi‑part ISO 10555 series on sterile, single‑use intravascular catheters. Relevant related documents include ISO 10555-1 (General requirements), ISO 10555-3 (Central venous catheters) and ISO 11070 (sterile single‑use intravascular introducers, dilators and guidewires) among others in the series. National/adopted versions (e.g., BS ISO, NF ISO) may be published by national bodies.

Keywords

ISO 10555-7, peripherally inserted central catheter, PICC, intravascular catheter, sterile, single‑use, test method, ISO 10555 series, ISO/TC 84.

FAQ

Q: What is this standard?

A: ISO 10555-7:2023 is an International Standard that defines general requirements and a test method specifically for peripherally inserted central catheters (PICC) supplied sterile and intended for single use.

Q: What does it cover?

A: It covers general performance and testing requirements for PICCs, including standardized test method(s) and exclusions (it does not cover accessories that are dealt with in other standards such as ISO 11070).

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, regulatory and quality teams, hospital procurement/clinical engineering, and clinicians involved in device selection and risk management.

Q: Is it current or superseded?

A: Current — ISO 10555-7:2023 was published in December 2023 (ISO publication record). National adoptions published by bodies such as BSI or AFNOR may carry their own publication dates and pagination.

Q: Is it part of a series?

A: Yes — it is one part of the ISO 10555 series on sterile, single‑use intravascular catheters (other parts address general requirements, central venous catheters, peripheral catheters, implanted ports, etc.).

Q: What are the key keywords?

A: PICC, peripherally inserted central catheter, intravascular catheter, sterile, single‑use, ISO 10555, test method, medical device.