ISO 28620:2020 pdf download

ISO 28620:2020 pdf download

ISO 28620:2020 pdf download.Medical devices — Non-electrically driven portable infusion devices
1 Scope
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 filled 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,
— 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).
2 Normative references
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 — Part 1: Evaluation and testing within a risk management process
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 80369-1, Small-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 — Part 6: Connectors for neuraxial applications
6.9.2 Procedure
Assemble the fluid filter and position it so that it is equivalent to that of one actually used in a suitable test apparatus in accordance with Figure 2. Cut the tubing of the device to approximately 100 mm below the fluid filter. Flush the fluid filter with 5 ml of the test fluid from the storage bottle and discard the filtrate. Pass 100 ml of the test fluid through the fluid filter and collect the effluent under a vacuum after passing it through a black gridded membrane filter with a pore size of 5 µm to 8 µm and 47 mm diameter. Mount the membrane with any retained latex particles on a suitable microscope slide or holder and count the latex particles in a minimum of 50 % of the grid squares under a magnification of × 50 to × 100. Disregard any particles that are obviously non-latex. All procedures involved in this test should be conducted in a clean environment and, if possible, under a laminar flow.