ISO 10555-7:2023 PDF

Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters

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Title (English):

ISO 10555-7:2023

Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 5
Publication date:: December 18, 2023
Edition:: ISO IS 10555 edition 1 version 1
ICS:: 11.040.25

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Description (English):

This document specifies general requirements and test method for peripherally inserted central catheters (PICC), supplied in the sterile condition and intended for single use, for any application. It is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.

Technical details

Technical committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 10555-7:2023

Abstract

Overview

ISO 10555-7:2023 specifies general requirements and test methods for peripherally inserted central catheters (PICC) supplied in the sterile condition and intended for single use. The standard applies to PICCs for any application but excludes intravascular catheter accessories (e.g., those covered by ISO 11070). It supplements the general ISO 10555 series by addressing PICC-specific markings, tensile testing and manufacturer information.

Key topics and technical requirements

Scope and applicability
- Applies to sterile, single‑use peripherally inserted central catheters (PICC).
- Not applicable to catheter accessories covered by ISO 11070.
Conformance
- Catheters shall conform to ISO 10555-1 (general requirements) except where ISO 10555-7 provides alternate tensile requirements.
Distance markings
- If provided, distance marking system must indicate catheter length; distance between marks shall not exceed 5 cm from the first mark.
Lumen markings
- For multi‑lumen PICCs, each lumen must be clearly identifiable; for staggered tips the relative position of distal openings must be apparent.
Peak tensile force (shaft and tip)
- Test method follows ISO 10555‑1; tensile requirement values are specified in ISO 10555‑7.
- For silicone catheters (excluding tip), minimum peak tensile force depends on effective outside diameter:
  - ≥ 0.75 mm and

Related standards

Standards mentioned in the description

Overview

Key topics and technical requirements

Scope and applicability
- Applies to sterile, single‑use peripherally inserted central catheters (PICC).
- Not applicable to catheter accessories covered by ISO 11070.
Conformance
- Catheters shall conform to ISO 10555-1 (general requirements) except where ISO 10555-7 provides alternate tensile requirements.
Distance markings
- If provided, distance marking system must indicate catheter length; distance between marks shall not exceed 5 cm from the first mark.
Lumen markings
- For multi‑lumen PICCs, each lumen must be clearly identifiable; for staggered tips the relative position of distal openings must be apparent.
Peak tensile force (shaft and tip)
- Test method follows ISO 10555‑1; tensile requirement values are specified in ISO 10555‑7.
- For silicone catheters (excluding tip), minimum peak tensile force depends on effective outside diameter:
  - ≥ 0.75 mm and

ISO 10555-7:2023 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Related standards

Abstract

Overview

Key topics and technical requirements

Related standards

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:201…

Sterile, single-use intravascular catheters - Angiographic catheters

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

Intravascular catheters. Sterile and single-use catheters. Peripherally inserted central catheters.