Guideline for Users of Ultra-portable X-ray Equipment

This guideline sets out requirements and recommendations for radiation safety associated with the use of ultra-portable diagnostic X-ray equipment. It represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the safety, efficacy, and quality of X-ray equipment. The Hazardous Substances Act, 1973 (Act 15 of 1973) and Regulations (No R1332 of 3 August 1973) govern the safe use of X-ray equipment in South Africa. The Medicines and Related Substances Act 101 of 1965 governs the regulation of all medical devices in South Africa.