ISO 10555-6:2015 PDF

Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports

Название (английский):

ISO 10555-6:2015

Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 15 апреля 2015 г.
Издание:: ISO IS 10555 edition 1 version 1
ICS:: 11.040.25

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Описание (английский):

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 10555-6:2015

Abstract

Overview

ISO 10555-6:2015 - Intravascular catheters - Part 6: Subcutaneous implanted ports - specifies requirements, performance criteria, and user-safety considerations for sterile, single‑use subcutaneous implanted ports and their catheters intended for long‑term intravascular access. The standard applies to devices supplied sterile and intended for single use; it explicitly excludes specifying requirements related to non‑coring needles. ISO 10555-6 is part of the ISO 10555 series covering sterile single‑use intravascular catheters.

Key topics and technical requirements

Scope and definitions: Clarifies terms such as reservoir, septum, priming and flushing volumes, outlet tube, and effective surface area.
Biocompatibility: Devices shall be free from biological hazards; ISO 10993‑1 is referenced for test selection.
Physical requirements:
- Radio‑detectability: Port, catheter and connections must comply with ISO 10555‑1 radio‑detectability rules.
- Surface finish: Visual inspection (≥×2.5 magnification) for absence of extraneous matter.
- Freedom from leakage: Leakage tests in Annex A and D; leakage considered unacceptable if pressure drop > 2.65 kPa in 2 min or if 200 kPa cannot be attained.
- Septum characteristics: Guidance on needle penetration and withdrawal forces (Annex C) and resistance to multiple punctures (Annex D).
- Connection strength: Minimum peak tensile force for port–catheter connection is 5 N (Annex E).
Fluid performance:
- Flow rate: Minimum measured flow per lumen must be ≥80% of manufacturer claim for catheters

Overview

Key topics and technical requirements

Scope and definitions: Clarifies terms such as reservoir, septum, priming and flushing volumes, outlet tube, and effective surface area.
Biocompatibility: Devices shall be free from biological hazards; ISO 10993‑1 is referenced for test selection.
Physical requirements:
- Radio‑detectability: Port, catheter and connections must comply with ISO 10555‑1 radio‑detectability rules.
- Surface finish: Visual inspection (≥×2.5 magnification) for absence of extraneous matter.
- Freedom from leakage: Leakage tests in Annex A and D; leakage considered unacceptable if pressure drop > 2.65 kPa in 2 min or if 200 kPa cannot be attained.
- Septum characteristics: Guidance on needle penetration and withdrawal forces (Annex C) and resistance to multiple punctures (Annex D).
- Connection strength: Minimum peak tensile force for port–catheter connection is 5 N (Annex E).
Fluid performance:
- Flow rate: Minimum measured flow per lumen must be ≥80% of manufacturer claim for catheters

ISO 10555-6:2015 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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