BS ISO 28620:2020 pdf free.Medical devices一Non-electrically driven portable infusion devices.
BS ISO 28620 This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called “device”.It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications.
NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.These devices can be pre-filled by the manufacturer or flld before use by a health care professional or 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, 一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).The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices一Part 1: Evaluation and testing within a risk management process ISO 15223-1, Medical devices一Symbols to be used with medical device labels, labelling and information to be supplied一Part 1: General requirements ISO 80369-1, Smal-bore connectors for liquids and gases in healthcare applications – – Part 1: General requirements ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications一Part 6: Connectors for neuraxial applications.BS ISO 28620 pdf download.