ISO 10555-1:2023 PDF
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 43
- Дата публикации:
- 14 ноября 2023 г.
- Издание:
- ISO IS 10555 edition 3 version 1
- ICS:
- 11.040.25
This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.
Abstract
Overview
ISO 10555-1:2023 - "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements" - specifies the general requirements and test methods for intravascular catheters supplied sterile and intended for single use. This third edition updates and replaces and incorporates changes covering risk management, usability engineering, sterilization, shelf life, packaging, and new or revised test methods. The standard applies to catheters for any intravascular application but does apply to catheter accessories (for example, those covered by ).
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