Standards for COVID-19
ARSO Joins the International Community in providing Solutions to the COVID-19 Pandemic
With the Covid-19 pandemic intensifying globally, including in Africa and in the face of such an alarming situation that is exacting a heavy toll on countries’ health-care services and threatening the World Economy, than ever before, in recent times, the ARSO Fraternity joins African leaders, under the Africa Centres for Disease Control and Prevention (Africa CDC) and the International Community, under the WHO in recognising all the efforts being put in place to control the pandemic and is rendering itself to offering the standardisation initiatives for the management of the Pandemic. ARSO recognises the declaration of the COVID-19 outbreak a Pandemic and a Public Health Emergency of International Concern by the WHO, and the safety guidelines thereafter, as well as the institution of the WHO Research and Development (R&D) Blueprint activated to accelerate the development of diagnostics, vaccines and therapeutics for the COVID-19. Further ARSO recognises the efforts of the WHO in reinforcing political advocacy on COVID-19 around the globe, and the naming of 6 global envoys with Africa represented by Dr. John Nkengasong, the Director of the Africa CDC; Dr Samba Sow, Director General of the Centre for Vaccine Development in Mali; and Prof Maha El Rabbat, former Health Minister of Egypt. ARSO highlights the initiatives of the WHO’s Regional Office for Africa in hosting a virtual ‘hackathon’ bringing together 100 leading innovators to pioneer creative local solutions to the COVID-19 pandemic and to address critical gaps in the regional response, with proposals ranging from mobile-driven self-diagnosis, screening and mapping tools to alternative low-cost methods for producing personal protective equipment (PPE).
ARSO attest to the fact that under the current prevailing circumstances of complete lockdown of countries borders, the demand for safe and quality preventive measures (face masks, sanitizers, safe water and soaps, medical gloves, clinical electrical thermometers, medical waste management and disposal), Personal Preventive Equipment (PPE), medicines, vaccines, diagnostics and reagents, is urgent, and has offered yet a more concrete evidence of the enduring role of standards and the related quality infrastructure components (technical regulations, conformity assessment regimes (testing, certification, inspections), metrology, accreditation, market surveillance and quality assurance), in enhancing Government policy objectives, not only in trade of products and services, but also in Public Policy, human health, Safety and environmental management with regards to Risk/Waste managements.
ARSO is cognizant of the fact that, in the world-over, including Africa, many standardization institutions are playing a key role in quality assurance of the medical products needed for the management of the COVID-19 pandemics. ARSO commends the African Standardization Community, including the National Bureau of Standards and Certification Bodies that have taken leadership role to offer, free of charge, the necessary standards and guidelines for the manufacture, testing and certification of the much needed Covid-19 preventive measures and products. ARSO takes note of the initiatives by ISO to make its 20 standards (https://www.iso.org/covid19) (already been circulated to ARSO Members and Stakeholders) freely available in response to the efforts to manage the COVID-19. ARSO further commends AFNOR for taking the initiative of drawing on the collective wisdom of leading experts to produce, in a record time of 7 days, a reference document, AFNOR Spec – Barrier masks, and available free of charge, proposing the requirements that should be satisfied when making new protective masks. ARSO also highlights the respective European Standards by CEN CENELEC, IEC (https://www.eu-esf.org/covid-19/4517-covid-19-en-standards-available-free-of-charge), The ASTM (https://www.ifai.com/2020/04/01/astm-providing-free-access-to-covid-19-related-standards/), the SAC- China, among other stakeholders for availing standards for the mitigation of the disruptive COVID-19. Further in noting therefore, that need for standards comparison and harmonisation is also correspondingly growing, and in taking into consideration the already existing and shared ARSO FDARS 1470: 2019 Hand Sanitizers (alcohol based) – Specification, ARSO is intensifying its focus in promoting the COVID-19 standards and conformity Assessment in Africa.
Going forward, in Post COVID-19, ARSO appreciates the need for new collaborative initiatives and rapid implementation of the necessary interventions in a timely manner and at the appropriate scale to stop or slow down such pandemics while minimizing economic, public and social impacts, with the participation of the Private Sector/Industry.
Contribution of African Traditional Medicine in Combating Coronavirus Disease (Covid-19)
The standardization of herbal medicines compared to orthodox medicines in Africa by regulating agencies and health institutions is comparatively lagging. Both the users and the care givers need to be involved in the standardization of the products. Since 2014, the African Organisation for Standardisation has engaged in the harmonization of standards for African Traditional Medicine (ATM) which address, the challenges highlighted in order to make the ATM a viable contributor to the healthcare systems of African countries. The following is a highlight of the standards which have been harmonized and those in the process of development. For the purpose of this brief, a few standards have been highlighted in relation to their contribution to combating the Covid-2019. Read More Below…
The ARSO FDARS 1470: 2019 Hand Sanitizers (alcohol based) – Specification at a glance
This African standard prescribes the requirements and methods of test for alcohol based instant hand sanitizers. The standard does not cover non-alcohol-based hand sanitizers. The alcohol contained within hand sanitizers, when rubbed on the surface of skin is effective in killing 99.9% of dangerous germs on the skin. The type of alcohol used in most hand sanitizers is ethyl alcohol. Ethyl alcohol is the active ingredient in most hand sanitizers. A concentration of 60% to 95% alcohol in hand sanitizing product is recommended. However, there are also non-alcohol-based hand sanitizers which can be effective in killing germs. For instance, Benzalkonium Chloride (BAC) has been proven effective in killing 99.9% of germs.
The Standard was prepared by the ARSO Technical Harmonization Committee Number 5 on Chemistry and Chemical Engineering (ARSO/THC 05).
The Standards is referenced to
- AOAC Official Method 942.06 Alcohol by Volume in Distilled Liquors Pycnometer Method
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products
- ISO 862, Surface active agents — Vocabulary
AFRICAN STANDARDS IN RESPONSE TO THE COVID-19 PANDEMIC
- ARS 1651: 2018 – Good Financial Grant Practice (GFGP), – used by AAS, to support Organisations to access their compliance against the requirements of the Standard, to receive award funds quickly and respond to the COVID-19 pandemic sooner and efficietly (https://www.aasciences.africa/covid-19-updates; https://globalgrantcommunity.com/; https://www.youtube.com/watch?v=GOkOIdWxC-0&=&feature=youtu.be)
- ARSO FDARS 1470: 2019 Hand Sanitizers (alcohol based) – Specification
- ARS 489:2018, Toilet soap — Specification
- ARS 490:2018, Laundry soap — Specification
- ARS 1472:2018, Cleaning chemicals for use in food industry
- EN 13795-1:2019, Surgical clothing and drapes — Requirements and test methods — Part 1: Surgical drapes and gowns
- ARS 950:2016, African Traditional Medicine — Terms and terminology
- ARS 951:2016, African Traditional Medicine — Good manufacturing practices (GMP) for herbal medicines
- ARS 952:2016, African Traditional Medicine — Guidelines on good agricultural and collection practices (GACP) for medicinal plants
- ARS 953:2016, African Traditional Medicine — Certification schemes for medicinal plant produce
- ARS 954:2016, Minimumrequirements for registration of traditional medicines
- ARS 955:2016,African Traditional Medicine — Technical guidelines for safety, efficacy and quality of raw materials and herbal medicines
- ARS 956-1:2016, African Traditional Medicine — Medicinal plant standards —Aloe vera L. Burm.f.
- FDARS 1455:2019, Bathing bars — Specification
- FDARS 1465:2019, Hand dishwashing and light duty detergent (liquid) — Specification
- FDARS 1470:2019, Hand sanitizers (alcohol based) — Specification
- FDARS 1474:2019, Antibacterial bathing bars — Specification
- CD-ARS 1457:2019, General purpose pure soap — Specification
- CD-ARS 1459:2019, Carbolic soap — Specification
- CD-ARS 1461:2019, Washing bars (performance-based) — Specification
- WD-ARS 1453:2019, Liquid toilet soap — Specification
- WD-ARS 1454:2019, Gel soap — Specification
- WD-ARS 1460:2019, Baby toilet soaps — Specification
- WD-ARS 1468:2019, Anti-bacterial liquid toilet soap — Specification
- WD-ARS 1469:2019, Anti-bacterial solid toilet soap — Specification
- WD-ARS 1475:2019, General purpose liquid soap — Specification
- WD-ARS 956-7:2019, ATM — MPS — Prunus Africana
- WD-ARS 956-8:2019, ATM — MPS — Vernonia amygdalina (bitter leaf)
- WD-ARS 956-9:2019, ATM — MPS — Dioscorea bulbifera
- WD-ARS 956-10:2019, ATM — MPS — Adansonia digitate
- WD-ARS 956-11:2019, ATM — MPS — Garcinia kola
- WD-ARS 956-12:2019, ATM — MPS — Hibiscus sabdariffa
- WD-ARS 956-13:2019, ATM — MPS — Irvingia gabonensis
- WD-ARS 956-14:2019, ATM — MPS — Ocimum gratissimum (scent leaf)
ARSO MEMBERS STATES RESPONSE TO THE COVID-19 PANDEMIC
“In a bid to complement the Government efforts related to protective measures set in place to fight against the spread of COVID-19 virus; RSB is pleased to share with Manufacturers, Importers, Exporters, Traders, Regulators, Government Ministries, Consumers and the general public in general; National, Regional and International Standards which contribute to combat COVID-19 crisis. These standards are freely available and can be downloaded from RSB website at www.rsb.gov.rw or at ISO www.iso.org/covid19.”
- RS EAS 789:2013;Instant hand sanitizers — Specification
- RS 383: 2018, Antiseptics based on chlorhexidine gluconate — Specification
- RS EAS 878: 2017, Antibacterial bathing bar — Specification
- RS EAS 812-1:2015 Liquid hand wash — Specification — Part 1: Synthetic and combined (soap and synthetic) hand wash
- RS EAS 186: 2013, Toilet soap — Specification
- RS ISO 13688:2013 Protective clothing – General requirements
KEBS/Kenya –https://www.kebs.org/; https://www.kebs.org/index.php?option=com_content&view=article&id=671&Itemid=558
KS EAS 794:2013 –Determination of the microbiological inhibition of cosmetic soap bars and liquid hand and body washes
- KS EAS 812-1 for Hand Wash
- KS OIML R114:1995 – Clinical electrical thermometers for continuous measurement
- Ks OIML R115:1995 – Clinical electrical thermometers with maximum device
- KS EAS 789:2013, Instant hand sanitizers – Specification
- KS 2636:2016, Surgical masks – Specification
- KS_ISO_10282_2014 Single-use sterile rubber surgical gloves – Specification
- KS_ISO_10651_5_2006 Lung ventilators for medical use — Particular requirements for basic safety and essential performance
- KS_ISO_11193_1_2008 Single-use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution
- KS_ISO_11193_1_2008_Amd_1_2012
- KS ISO 11193-2: 2006 – Single-use medical examination gloves – Part 2 : Specification for gloves made from poly(vinylchloride)
- KS_ISO_80601_2_74_2017 Medical electrical equipment
- KPAS 2917_2020 Reusable cloth mask — Specification
- KPAS 2918_2020 Critical care ventilators — Specification
- KS_ISO_13688_2013 Protective clothing — General requirements
Cameroon convened a meeting of Technical Committee 29 – Pharmaceutical and medical engineering on April 13, 2020. The objective of the meeting, attended by the ANOR Director General and ARSO President , as well as the Ministers of Mines, Industry and Technological Development, was to develop Cameroonian Standards emergency procedure on hydro-alcoholic gels, barrier masks, gloves, protective devices and protective clothing. 14 standards (LISTED BELOW) were adopted, approved and made mandatory by order of the Minister of Mines, Industry and Technological Development N ° 000096 / MINMIDT of April 13, 2020 where any product imported or manufactured locally had to be accompanied by a Certificate of Conformity, to these standards, issued by the ANOR, due during the customs clearance procedure or during the controls carried out by the ANOR in liaison with the administrations concerned.
- NC 2969, Gants de protection – Exigences générales et méthodes d’essai
- NC 2970 – Masques barrières : Guides d’exigences minimales de méthodes
- NC 2971 – Masques à usage ; fabrication en série et confection artisanale
- NC 2972 – Appareil de protection respiratoire – Demi-masques filtrants contre les particules-Exigences, essais, marquage et sa feuille d’instruction
- NC 2973 – Protection individuelle de l’œil: spécifications
- NC 2974 – Vêtements de protection : Exigences de performances et de méthodes d’essai pour les vêtements de protection contre les agents infectieux
- NC 2975 – Vêtements et champs chirurgicaux – Exigences et méthodes d’essai- partie 1 : champs et casaques chirurgicaux
- NC 2976 – Vêtements et champs chirurgicaux – Exigences et méthodes d’essai partie 2 : Tenues de bloc
- NC 2977 – Gants médicaux non réutilisables-partie 1 : détection des trous-Prescriptions et essais
- NC 2978 – Gants médicaux non réutilisables-partie 2 : Exigence et essais pour propretés physiques
- NC 2979 – Gants médicaux non réutilisables-partie 3 : Exigence et essais pour évaluation biologique
- NC 2980 – Gants médicaux non réutilisables-partie 4 : Exigence et essais relatifs à la détermination de la durée de conservation
- NC 2981 – vêtements de protection à utiliser contre les particules solides – Partie 1 : Exigence de performance des vêtements de protection contre les produits chimiques offrant une protection au corps entier contre particules solides transportées par l’air (vêtements de type 5)
NC 2982 – Hand Sanitizers (alcohol based) – Specification
“Standards and Certification for the Fight against COVID – 19”
In order to contribute to the fight against the pandemic Covid-19, the IMANOR mobilized its staff and stakeholders to develop reference standards covering protective equipment. Thus the following technical specifications were developed and published:
- NM & T / 21.5.200: Masks nonwoven fabric
- NM & T / 21.5.201: Protective masks reusable cloth
- NM & T / 21.5.204: Protective Visors
Another technical specification for protective suits nonwoven fabric is being validated and will be published shortly.
The IMANOR also established three certification schemes respectively covering masks nonwoven fabric, protective masks reusable cloth and protective visors. The balance sheet certified companies achieved so far is as follows:
- Protective masks cloth nonwoven 48 certified companies for a production capacity of over 7 million masks / day
- Protective masks reusable cloth; 85 companies certified for a production capacity of about 2 million masks / day
- Protective visors: 5 certified companies for a production capacity of about 150,000 visors / day
Also, more than 150 companies engaged in the protection of their equipment certification process.
The allocation of the IMANOR certification for this protective equipment is based on the results of tests performed by three laboratories, respectively in the plastics and textiles, as well as the results of the on-site assessment of hygiene conditions relationship with the Covid 19 and storage conditions and packaging of protective equipment. The actions of the IMANOR in this context have been reinforced by the publication of a decree of the Minister of Industry and Trade requiring compliance with the above reference standards for sale to protective equipment in question. Similarly, the authorities encourage companies wishing to engage in the production of protective equipment against Coronavirus to have previously a compliance certification of their products with the applicable technical specifications. In this context, the importance of standards and certification and their role in consumer protection and manufacture of quality products fit for use, have been widely publicized recently in Morocco and brought to public knowledge by various means.
Technical specifications, lists maintained update of the certified companies that produce protective equipment and other relevant information are available on a web page dedicated to the standardization and certification of equipment to protect against the virus. Access to this information is via two links:
– For protective masks https://www.imanor.gov.ma/certification-des-masques-de-protection/
– For visors Protection: https://www.imanor.gov.ma/certification-des-visieres/