ISO/TR 19727:2017 PDF
Medical devices — Pump tube spallation test — General procedure
Medical devices — Pump tube spallation test — General procedure
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 17 августа 2017 г.
- Издание:
- ISO TR 19727 edition 1 version 1
- ICS:
- 11.040.20
ISO/TR 19727:2017 provides a method of measuring, analysing and assessing the particle shedding from an infusion pump set during pumping.
Abstract
Overview
ISO/TR 19727:2017 - Medical devices - Pump tube spallation test - General procedure is a technical report developed by the International Organization for Standardization (ISO). This standard provides a systematic method for measuring, analyzing, and assessing particle shedding-referred to as "spallation"-from infusion pump sets during operation. Reducing and monitoring particle contamination is crucial for the safety and effectiveness of medical infusion devices, making this standard highly relevant to manufacturers, laboratories, and regulatory agencies involved in medical device quality control.
Похожие стандарты
Стандарты, упомянутые в описании