ISO 14972:1998 PDF
Sterile obturators for single use with over-needle peripheral intravascular catheters
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
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.
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–
Технические детали
- Технический комитет
- ISO/TC 84 - Devices for administration of medicinal products and catheters
- SKU
- ISO 14972:1998
Похожие стандарты
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