Medical oxygen is a medicinal product and, as such, subject to strict regulations to ensure its safety, quality, and effectiveness.
For individuals who require supplemental oxygen, renting an oxygen cylinder is a common and practical solution but it is essential to understand the medical standards that govern these cylinders, as they are not just ordinary containers of gas — they are life-sustaining medical devices.
Awareness of the following standards helps users make informed decisions, avoid safety risks, and ensure proper care during oxygen therapy.
Compliance with Medical Gas Regulations
In South Africa, medical oxygen is classified as a Schedule 4 medicine and is regulated by the South African Health Products Regulatory Authority (SAHPRA). Oxygen cylinders must meet strict manufacturing and safety standards to ensure the gas is safe for therapeutic use. The oxygen supplied must be of medical-grade purity (typically 99.5% or higher) and free from harmful contaminants, such as moisture, dust, or hydrocarbons.
Suppliers must be registered with SAHPRA and licensed to handle and distribute medicinal gases. Before renting an oxygen cylinder, it is essential to confirm that the provider complies with SAHPRA regulations and follows the relevant Good Manufacturing Practice (GMP) guidelines. Using industrial-grade oxygen or renting from unlicensed sources is highly dangerous and can pose significant health risks. Only medical-grade oxygen, filled and handled under approved conditions, should ever be used for patient care.
Cylinder Construction and Labelling Standards
In South Africa, medical oxygen cylinders must be manufactured and maintained in accordance with the standards set by the South African Bureau of Standards (SABS), particularly SANS 10019, which governs the design, inspection, and use of gas cylinders.
Each medical cylinder must be clearly and permanently marked with key information, including:
- The product name: “Medical Oxygen”
- The volume and working pressure
- The cylinder serial number and test date
- The batch number and gas expiry date
- The name of the manufacturer or gas supplier
Cylinders containing oxygen must also have a white shoulder or top, which is the standard colour code in South Africa for medical oxygen.
Hygiene and Sterility Protocols
Before a medical oxygen cylinder is reissued for rental, it must be thoroughly inspected, cleaned, and disinfected. This includes sterilising the valve outlet and ensuring the cylinder is free from oil, grease, or other contaminants that could pose a fire or infection hazard. Nasal cannulae, masks, and tubing are single-use items and must be replaced with each rental.
Safety and Handling Standards
Medical oxygen is a highly reactive gas, and its use is governed by strict safety standards to prevent accidents such as fire, leaks, or cylinder damage. Cylinders must:
- Be stored in an upright position and secured to prevent falling
- Never be exposed to flames, smoking, or high heat
- Include functioning pressure regulators and safety valves
- Be transported with valve protection caps in place
Medical oxygen cylinders must undergo periodic pressure testing, typically every five years, to ensure they are structurally sound and safe to use. This testing must be carried out by authorised facilities, and the test date is stamped on the cylinder body.
