Is your audiometer SANS approved for South Africa?
Audiometers utilized within South Africa for audiometric purposes have to comply with all relevant international and national standards for hearing assessment purposes. This article will outline the requirements that an audiometer has to tick in order to comply with the South African National Standard (SANS). If there is no CE mark on your audiometer or no DoH (Radiation Control) license certificate then the audiometer may not be used in South Africa.
CE Mark and Radiation control license
It is a simple process to confirm if your audiometer can legally be used in South Africa. Search for your audiometer on this list published by the Department of Health Radiation Control or look for the CE mark affixed to your device – it is that simple. The CE mark should be followed by four digits. These numbers signify the accreditation body that issued the certificate for CE. This certificate gives a manufacturer permission to affix the CE mark to a medical device. The KUDUwave label indicates four digits namely 0086. This confirms that the British Standards Institute UK issued the KUDUwave certificate.
This CE mark is very important in South Africa, as it is one of the key requirements needed to qualify an audiometer to receive a license for distribution into South Africa. This is a requirement by the Department of Health Radiation Control, as per the Hazardous and Substance Act. Without this license, you may not distribute audiometers in South Africa. If the supplier of your audiometer cannot provide you with a Radiation control license, then the audiometer is a possible hazard, as per South African law, and may be recalled. This schedule of listed electronic products specifies that Audiometers need to be licensed under the Hazardous Substance Act, No 15, 1973.
The KUDUwave™️ Radiation Control License can be downloaded here.
IEC 60645-1 compliance
Every audiometer must comply to IEC 60645-1* as per SANS 10083**. If your audiometer carries the CE mark it serves as evidence that the audiometer is IEC 60645-1*** compliant.
SANS 10083 states that an audiometer must comply with the requirements for at least a type 4 audiometer specified in IEC 60645-1, for baseline, periodic screening and exit audiometry.
The Occupational Health and Safety Act references this standard, therefore SANS 10083 is regulatory and as such, a legal requirement. If your audiometer carries the medical CE mark, then it complies to this standard. However, if your audiometer is FDA approved, and does not carry the CE mark, then your audiometer cannot be used for SANS testing. FDA certification is not accepted in South Africa.
Your trusted equipment supplier might be making a fortune out of selling you cheaper non-CE approved audiometers. These non-CE approved audiometers may give inaccurate test results and in that case, you may just as well use a cellphone to test your patients. There are many substandard non-clinical cellphone apps that you can download from the Google Play Store for free. Maybe a friend could quickly write you an audiometer app to use. However, be warned – that would be illegal because the only way your audiometer can comply to IEC 60645-1 is if the audiometer (and the app) carries the medical CE mark and the audiometer is calibrated by an ISO 17025**** company to the IEC 60645-1 standard.
IEC 60645-1 ‘’specifies general requirements for audiometers designed for use in determining hearing threshold levels, relative to standard reference threshold levels established by means of psychoacoustic test methods, and those designed to perform psychoacoustic tests using speech material.’’.
Therefore, compliance with IEC 60645-1 is of clinical importance! Failure to comply may result in inaccurate hearing acuity measurements and resultantly, inaccurate management of hearing loss.
The KUDUwave declaration of conformity which specifies that the KUDUwave complies to IEC 60645-1 can be downloaded here.
How to verify that your audiometer is licenced
To ensure that your current audiometer can be used in South Africa, you can reference the following list published by the Department of Health Radiation Control.
If your audiometer does not appear on this list, it is most likely not licensed, and therefore cannot legally be used in South Africa.
It is crucial that the audiometer that one uses to render hearing health care is registered for use in South Africa (or their respective country). Firstly, this is important to ensure that accurate assessment and management of patients is guaranteed. Secondly, it goes without saying that the protection of humans (i.e. patients) is not up for debate when providing healthcare services. Thus, an audiometer without Radiation control license is a possible hazard that could harm the patient – and yourself as the practitioner.
The legalities of audiometers in South Africa do not end here. As a practitioner, you have the responsibility to ensure that your audiometer’s calibrations are valid and up to date. It may be worth your while reading this article which will guide you through steps to assess whether your South African audiometer calibrations are valid.
Please feel free to:
- contact eMoyo for more information,
- or contact the Department of Health Radiation Control directly to verify your audiometer is listed for use in South Africa,
- or contact the Department of Labour directly to verify what we said about IEC 60645-1 and your audiometer as well as ISO 17025 and your calibration company.
You stand the risk of failing your audits if your audiometer does not carry the CE mark, does not have a DoH Radiation Control license and is not calibrated by a company that conforms to ISO 17025.
* Electroacoustics – Audiometric equipment Part 1: Equipment for pure-tone and speech audiometry
** The measurement and assessment of occupational noise for hearing conservation purposes
*** For a medical device to receive the CE mark, compliance with the old Medical Device Directive (Council Directive 93/42/EEC) and the new Medical Device Regulation (Regulation (EU) 2017/745) is required to comply to all the relevant harmonised standards, and for an audiometer, EN 606045-1 is one of them.
**** Stipulated in SANS 10154-1