What is ISO 11197- Medical supply unit about?
ISO 11197 is an international standard that focuses on medical supply units. ISO 11197 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
ISO 11197 also applies to medical supply units manufactured within a factory or assembled on-site, including cabinetry and other enclosures, which incorporate patient care services.
ISO 11197 helps you improve the basic safety and performance of medical supply equipment.
Note-
A party that assembles on-site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Who is ISO 11197- Medical supply unit for?
ISO 11197 on the medical supply unit is useful for:
- Manufacturers of medical supply units
- Assembly point
- Hospitals
- Health care services
- Design, construction, inspection, testing, maintenance, and operation providers of healthcare facilities
Why should you use ISO 11197- Medical supply unit?
Many healthcare facilities use surface-mounted or recessed containment systems and enclosures for accommodating and displaying essential patient care services. These are known as medical supply units.
ISO 11197 specifies medical supply units manufactured in factories or assembled from on-site components. ISO 11197 is intended for use by those persons involved in the design, construction, inspection, testing, maintenance, and operation of healthcare facilities as well as those manufacturing, assembling, and installing medical supply units.
Persons involved in the design, manufacture, installation, maintenance, and testing of equipment intended to be connected to gas for medicinal use, medical device gas, vacuum, anesthetic gas scavenging, and/or plume extraction systems should be aware of the contents of ISO 11197.
ISO 11197 guides you in the construction and maintenance of medical supply equipment.
What’s changed since the last update?
BS EN ISO 11197:2019 supersedes BS EN ISO 11197:2016. BS EN ISO 11197:2019 includes some technical changes concerning BS EN ISO 11197:2016. These include:
- Editorial revision
- Change in the requirements defining the inclusion of USB outlets within medical supply units
- Addition of methods of internal cabling connections and specific tests including but not limited to impact resistance
