ISO 10555-7:2023 PDF

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

Название (английский):

ISO 10555-7:2023

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 5
Дата публикации:: 18 декабря 2023 г.
Издание:: ISO IS 10555 edition 1 version 1
ICS:: 11.040.25

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Описание (английский):

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.

Технические детали

Технический комитет: 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

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

Технические детали

Abstract

Overview

Key topics and technical requirements

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Abstract

Overview

Key topics and technical requirements

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