Oxygen generators have become increasingly popular in recent years due to their ability to produce medical-grade oxygen on-site. This means that hospitals, clinics, and other healthcare facilities do not need to rely on external suppliers for oxygen supplies. Instead, they can generate their own oxygen using machines called oxygen generators that extract oxygen from ambient air.

Standards and regulations related to medical oxygen produced by oxygen generators are essential to ensure patient safety and the quality of the oxygen produced. These standards and regulations are set by regulatory bodies such as the European Pharmacopoeia and the International Organization for Standardization (ISO). In this blog, we will focus on the ISO standards related to oxygen generators.

ISO standards ensure that oxygen generators meet specific requirements related to the design, manufacture, installation, and maintenance of these machines. ISO 10083:2019 is the standard that specifies the requirements for the design, manufacture, installation, and maintenance of oxygen generators used in healthcare facilities.

ISO 10083:2019 provides guidance on the selection of oxygen generator systems based on the volume and concentration of oxygen required, the available utilities, and the available space. The standard also provides guidance on the installation, commissioning, and maintenance of the oxygen generator systems to ensure that they operate safely and effectively.

ISO 10083:2019 also requires that oxygen generators be designed to produce medical-grade oxygen that meets the requirements of the European Pharmacopoeia. The European Pharmacopoeia sets the specifications for the quality and purity of medical oxygen, including the maximum allowable limits for impurities and other contaminants.

In addition to ISO 10083:2019, there are other ISO standards related to oxygen generators, including ISO 7396-1:2016 and ISO 13485:2016. ISO 7396-1:2016 specifies the requirements for the design, installation, and maintenance of medical gas pipeline systems, including oxygen supply systems.

ISO 13485:2016 specifies the requirements for quality management systems for medical devices manufacturers. This standard ensures that manufacturers of oxygen generators adhere to specific quality management processes to ensure that their products are safe, effective, and meet regulatory requirements.

In summary, oxygen generators are essential medical devices that produce medical-grade oxygen to supply healthcare facilities, including hospitals, clinics, and other medical facilities. The ISO standards ensure that oxygen generators operate safely and effectively, produce medical-grade oxygen, and meet specific regulatory requirements. If you are considering purchasing an oxygen generator, make sure to choose an ISO-certified oxygen generator to ensure patient safety and the highest quality of oxygen.