标准编号：ISO 28620:2020
中文名称：医疗设备 非电动便携式输液设备
英文名称：Medical devices — Non-electrically driven portable infusion devices
发布日期：2020-01
标准范围
This document specifies essential requirements and related test methods for non-electrically drive portable infusion devices, thereafter called “device”.
It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxia and intravascular or hypodermic applications.
NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricle of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administere regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchia plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wound with local anaesthetic agents.
These devices can be used in health care and non-health care settings. They can be applied o administered by health care professionals or by the intended patient.
These devices can be pre-filled by the manufacturer or filled before use by a health care professional the intended patient.
This document does not apply to
— electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24,
— devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series,
— implantable devices,
— enteral devices,
— transdermal delivery devices, and
— devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).
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