What is ISO 28620 about?
ISO 28620 discusses non electrically driven portable infusion devices. ISO 28620 outlines essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called “device”.
ISO 28620 is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications.
These devices can be used in health care and non-healthcare 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.
Note 1: 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 brachial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
Note 2: ISO 28620 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 a 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).
Who is ISO 28620 for?
ISO 28620 on non-electrically driven portable infusion devices is useful for:
- Manufacturers of non-electrically driven portable infusion devices
- Test centres for non-electrically driven portable infusion devices
- Regulatory authorities
Why should you use ISO 28620?
Portable infusion device equipment intended for the controlled infusion of liquids into the patient and intended to be carried or worn by the patient.
ISO 28620 guideline helps you with components, design, characteristics, material, Operating requirements, Test Methods, and Information to be listed on the packaging and/or product for non electrically driven portable infusion devices. This helps in improving the quality of non-electrically driven portable infusion devices and ensures the health and safety of end-user.
What’s changed since the last update?
BS ISO 28620:2020 supersedes ISO 28620:2020, which has been withdrawn. BS ISO 28620:2020 has some technical changes with respect to ISO 28620:2020. These include:
- The Scope has been amended to explicitly cover neuraxial and intravascular or hypodermic applications
- The requirements on components and their fittings have been aligned with the appropriate parts of the ISO 80369 series, i.e., ISO 80369-1, ISO 80369-6, and ISO 80369-7
- The requirements on filter and tubing have been updated
- A test method for the efficiency of the fluid filter has been added
- Table 1, which gives information to be provided by the manufacturer, has been updated
