Sub-Directorate: Non-ionising Radiation and Electromedical Devices (NIRMED)

The Sub-Directorate: NIRMED is responsible for controlling the sale and use of a range of listed electronic products which can be divided up into two broad categories i.e. those producing non-ionising radiation and those classified as high and medium risk electromedical devices.

  1. Electronic products producing non-ionising radiation in turn are divided into three categories:
  1. The radiofrequency and microwave region stretches from 0 Hz (static magnetic fields) to 300 GHz. This region includes power frequency (50 Hz) electromagnetic fields, low frequency heat sealers, high frequency surgical and physiotherapy equipment and microwave applications such as cellular phones, microwave ovens and radar equipment.
  2. The optical radiation region stretches from infrared-C with a wavelength of 1 mm to ultraviolet-C with a wavelength of 180 nm. The optical region from 400 to 700 nm is also included.
  3. The acoustical region includes only devices producing ultrasound.
  1. Electromedical devices are divided into two broad categories:
  1. High risk electromedical devices consist of 20 generic device types such as intra-aortic balloon pumps, ventilators, cardiac pacemakers and defibrillators, syringe pumps and hemodialysis units.
  2. Medium risk electromedical devices consist of a further 18 generic device types such as electrocardiographs, electroencephalographs and physiological monitors .

The control of listed electronic products takes place on two levels i.e.

  1. At the Point of Import or Manufacture:

Any person who wishes to import or manufacture any of the above mentioned devices has to obtain a licence in terms of section 4(i) (b) of the Hazardous Substances Act, 1973 (Act 15 of 1973). This licence is issued if the product complies with the internationally recognized requirements for safety and performance. An application form has to be completed and a colour brochure, including technical specifications, must also be submitted.

  1. At the Point of Use:

In the case of a limited number of generic categories where non-ionising electromagnetic radiation is purposely produced, installation has a direct impact on the safety of the device. In these instances the user must obtain a licence to install and use the device. A licence is required to operate any device falling into one of the following categories: magnetic resonance imaging systems, Class 3 and 4 laser systems, radiofrequency heating devices, radar equipment and high-power radio communications equipment.

Limits for exposure to non-ionising radiation have been established by the International Commission for Non-Ionising Radiation Protection (ICNIRP) and these exposure limits are endorsed by the Department of Health.

Safe use guidelines for Class 3 and 4 lasers, radiofrequency and microwave devices and magnetic resonance imaging units have also been drawn up and are continually being updated as new information becomes available.

A sourcebook of all licensed electronic products is produced on an annual basis. Information on associated dealers, manufacturers and the distribution of products amongst the different generic categories is also provided.

Information is also collated, evaluated and distributed on topics where regulatory control has not been deemed necessary at the moment

CHIEF DIRECTORATE

Hospital Services

DIRECTORATE

Radiation Control

SUB-DIRECTORATE

Non-Ionising Radiation and Medical Devices (NIRMED)

AIM

To provide an appropriate standard of protection to all South African citizens against the hazardous effects of non-ionising radiation (NIR) without unduly limiting the beneficial applications of technologies employing the use of NIR;

To safeguard public health by working with the manufacturers, dealers and users of listed electromedical devices to ensure that these devices meet appropriate standards of safety and performance

VISION

To establish a regulatory environment where, on the one hand, users of electromedical devices and devices generating NIR can have sufficient assurance with regard to the safety and performance of these devices, and where, on the other hand, the entrepreneurial spirit of manufacturers and dealers is allowed to flourish as a result of the existence of reasonable and effective regulatory requirements that are consistent with internationally accepted regulatory principles and practice

FUNCTIONS
  1. Compile national safety standards and guidelines and formulate regulations
  2. Control the sale and use of listed electronic products
  3. Develop inspection procedures and carry out inspections
  4. Supply information and advice to manufacturers, distributors, maintenance personnel, users, inspectors, the media and the general public
  5. Conduct surveys on the application of specialised technologies
  6. Carry out inspections of specialised electronic products
  7. Evaluate and calibrate measuring equipment used for inspections and evaluations
  8. Maintain hazard notification system
  9. Evaluate tender specifications 
  10. Liaise and collaborate with international institutions, organisations and regulatory authorities

STAKEHOLDERS
(To whom does the this
Sub-Directorate deliver a service)

Manufacturers, distributors, maintenance personnel, users, inspectors, the media and general public

 

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