The South African Bureau of Standards (SABS) is aware that there are numerous claims that personal protective equipment (PPE) is ‘SABS Approved’ and consumers are being duped into using potentially harmful PPE. Consumers are urged to be vigilant and to buy quality products through legitimate delivery channels.
“While South Africans are desperate to purchase products such as masks, thermometers, sanitisers, disinfectants, gloves, and other equipment in order to protect themselves and their families against Covid-19, it is important that legitimate products are purchased. Products, even those that are SABS Approved need to be used for the intended purpose in order to be effective in the fight against the infection. SABS understands that there are increasingly new innovations that are emerging that claim to solve the myriad of health issues that the world is facing and while they could be life-saving, all innovative products must be subjected to testing to ensure that it is safe to use,” says Jodi Scholtz, Lead Administrator at SABS.
Scholtz advises the following:
Spray tunnels/booths and the ingestion of sanitisers
SABS has not conducted any tests or developed any national standard (SANS) for spray booths/tunnels nor any of the mechanisms used to spray disinfectants. There are currently no chemicals that are considered safe for use for disinfection via spray booths or tunnels. SABS supports the World Health Organization (WHO) and the National Department of Health (NDoH) in advising against the use of spray tunnels/booths and confirms that there are no SABS Approved chemicals that can be used via these mechanisms.
Sanitisers and disinfectant products are certified against South African National Standards (SANS) 490 and SANS 1853 in order to carry the SABS Approved Mark.
Uncertified products and products that are not used for their intended purpose could be dangerous for a number of reasons that include: adverse reactions to humans and the environment, the harmful effects of unidentified ingredients, bacterial and microbial impurities as well as simply just not being suitable for use on humans.
SABS currently does not conduct any temperature tests on thermometers that are intended for use on humans. Thermometers are medical devices and fall within the regulations by the South African Health Products Regulatory Authority (SAHPRA). Calibration of thermometers can be done in laboratories that have been calibrated by the South African National Accreditation System (SANAS) and SABS currently does not offer this service.
Masks and Shields
There are various categories of masks and shields that can be used in the fight against COVID-19. Currently all manufacturers of surgical masks are registered with SAHPRA. There are six national standards that provide masks for various uses:
- SABS 1866:2018 – Medical devices Part 1: Medical face masks. This standard covers the minimum performance requirements for materials used in the construction of medical face masks, intended to limit the transmission of infective agents in the healthcare environment.
- SANS 50136:1998 – Respiratory protective devices – full face masks – requirements, testing, marking. This standard sets the requirements for full faces masks for respiratory protective devices and excludes diving apparatus.
- SANS 50148:2003 – Respiratory protective devices – threads (three parts). This standard has three parts and applies to standard threads for respiratory devices and breathing apparatus.
- SANS 50149: 2003 – Respiratory protective devices – this standard specifies the requirements for filtering half masks as respiratory protective devices to protect against particles except for escape purposes.
- ITA1/WDED1 – general purpose face masks – fabric type – this industry technical agreement (ITA) is currently being developed by various industry experts. An ITA will expedite the process as consensus by the industry is required, whereas a National standard requires consensus by all parties.
SABS is able to conduct tests against some of these SANS and where there is limited capacity, utilises laboratories that fall within its partnership agreements.
Sanitisers, detergents and disinfectants
The technical committee (TC), SABS/TC 1022 is responsible for a wide range of standards within the field of antiseptics, disinfectants and detergent disinfectants. Of the 37 standards published by the TC, the two that are relevant to hand sanitisers which are alcohol-based, are contained in SANS 490 and SANS 1853.
Consumers are advised that there are various uses for sanitisers, detergents and disinfectants and these are mainly for non-human consumption. SABS is able to provide testing and certification services for products that fall within this category.
How can SABS help navigate the PPE requirements and contribute towards quality?
There are a number of role players that provide differing services in the various aspects of PPE such as the National Department of Health (NDoH), National Regulator for Compulsory Specifications (NRCS), South African National Accreditation System (SANAS), South African Health Products Regulatory Authority (SAHPR), National Metrology Institute of South Africa (NMISA) and SABS.
“Testing and certification of products, especially PPE is going to become increasingly important as South Africa deals with Covid-19. SABS has the capability to develop South African National Standards for products as well as offer testing and certification of products against those standards. In addition and based on the critical needs, tests can be conducted against specific requirements and via a consultative process to develop the requirements,” explains Scholtz.
Companies that are procuring PPE are advised to consult SABS on the standard and requirements that PPE should meet so that it can be included on tender documents and subjected to inspection. This will ensure that the products received are functional and meet the requirements for protecting South Africans. SABS also offers consignment inspection services to guard against defective productive being delivered and to ensure that there is an independent voice verifying the PPE being procured.