ISO 14972:1998 PDF

Sterile obturators for single use with over-needle peripheral intravascular catheters

Название (английский):

ISO 14972:1998

Sterile obturators for single use with over-needle peripheral intravascular catheters

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 20 декабря 1998 г.
Издание:: ISO IS 14972 edition 1 version 1
ICS:: 11.040.25

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Описание (английский):

This International Standard specifies requirements for obturators, supplied in the sterile condition and intended for single use for plugging over-needle peripheral catheters. NOTE Attention is drawn to ISO 10555-5, which specifies requirements for over-needle peripheral catheters.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 14972:1998

Abstract

Overview

ISO 14972:1998 defines requirements for sterile obturators for single use intended to plug the lumen of over-needle peripheral intravascular catheters. The standard covers design, sterilization, dimensional compatibility, labeling and essential manufacturer information to ensure safe, single-use obturators supplied in the sterile condition. It cross-references catheter requirements in ISO 10555-5.

Key topics and technical requirements

Scope and definition: Specifies obturators designed to be inserted into over-needle peripheral catheters to plug the lumen.
Sterility and sterilization: Obturators must be supplied sterile by a validated method (see ISO 11134, ISO 11135, ISO 11137 for sterilization methods).
Biocompatibility: Devices shall be free from biological hazard; see ISO 10993-1 for appropriate test methods.
Surface quality: External surface of the effective shaft length shall appear clean at 2.5× magnification and be free from defects to minimize vessel trauma.
Mechanical strength (force at break): Minimum tensile force at break is specified by obturator shaft outside diameter:
- 0.35–

Overview

Key topics and technical requirements

Scope and definition: Specifies obturators designed to be inserted into over-needle peripheral catheters to plug the lumen.
Sterility and sterilization: Obturators must be supplied sterile by a validated method (see ISO 11134, ISO 11135, ISO 11137 for sterilization methods).
Biocompatibility: Devices shall be free from biological hazard; see ISO 10993-1 for appropriate test methods.
Surface quality: External surface of the effective shaft length shall appear clean at 2.5× magnification and be free from defects to minimize vessel trauma.
Mechanical strength (force at break): Minimum tensile force at break is specified by obturator shaft outside diameter:
- 0.35–

ISO 14972:1998 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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