ISO 10555-5:2013 PDF

Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters

Название (английский):

ISO 10555-5:2013

Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 6 июня 2013 г.
Издание:: ISO IS 10555 edition 2 version 1
ICS:: 11.040.25

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Описание (английский):

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 10555-5:2013

Abstract

Overview

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters - sterile, single-use devices used to access the peripheral vascular system. This part of the ISO 10555 series focuses on the design, physical characteristics, testing and manufacturer information for over-needle peripheral catheters and their introducer needles.

Key topics and technical requirements

Scope & definitions: Identifies terms such as catheter unit, needle tube, needle hub, vent fitting and flashback.
Material and needle requirements: If steel needle tubing is used it shall comply with ISO 9626. Needle points must appear sharp and free from burrs under ×2.5 magnification and be designed to be non‑coring (Annex C describes typical geometries).
Physical design:
- The catheter distal end must be tapered and fit closely to the needle (needle fully inserted must not let catheter extend beyond heel of bevel or be more than 1 mm away).
- Colour coding: Hubs or fittings must be colour coded per Table 1 to indicate nominal outside diameter (corresponding gauge numbers optionally listed).
- Multilumen catheters must clearly identify each lumen.
Performance tests:
- Needle hub/tube union strength (Annex A): tensile/compressive testing - needles

Overview

Key topics and technical requirements

Scope & definitions: Identifies terms such as catheter unit, needle tube, needle hub, vent fitting and flashback.
Material and needle requirements: If steel needle tubing is used it shall comply with ISO 9626. Needle points must appear sharp and free from burrs under ×2.5 magnification and be designed to be non‑coring (Annex C describes typical geometries).
Physical design:
- The catheter distal end must be tapered and fit closely to the needle (needle fully inserted must not let catheter extend beyond heel of bevel or be more than 1 mm away).
- Colour coding: Hubs or fittings must be colour coded per Table 1 to indicate nominal outside diameter (corresponding gauge numbers optionally listed).
- Multilumen catheters must clearly identify each lumen.
Performance tests:
- Needle hub/tube union strength (Annex A): tensile/compressive testing - needles

ISO 10555-5:2013 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

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