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Outbreak 101: Timing & Urgent Need For Certification For New Face Mask

Face Mask, COVID19, Outbreak, ASTM Level 3, SIRIM, Empro

This is the face mask brand that we prescribe nowadays even though it is quite expensive compared to the cheap blue coloured ones sold in supermarkets. We get ours from the local pharmacy and it is a well-made face mask and it is locally made as well.

Face mask – the key essential item that was resulted from the COVID19 pandemic and if one recalls, it was so badly needed at the start of the pandemic that we had a shortage of face masks in the market. At that time, some face mask was being sold for a ridiculous price and in limited numbers. It was not enough for the whole family and the quality was really bad. Some of the online sales for masks turned out to be a major scam.

Read these first:-

SIRIM Certification Requirement

There’s a new ruling imposed on non-medical face masks that had gotten social media buzzing with questions.

Effective July 4, manufacturers and importers of non-medical face masks must apply for MS Sirim certification and labelling from Sirim QAS International Sdn Bhd.

According to the Domestic Trade and Consumer Affairs Ministry, the move was to ensure that non-medical face masks produced locally or imported, comply with the set safety standards set.

“The MS Sirim label must be placed on the boxes or packages and are easily visible to consumers.

“The MS Sirim label indicates that the non-medical face mask products have met the standards, are of quality and safe to use,” said the ministry in a statement yesterday, reported Bernama.

In addition, the ministry hopes that with the compliance of standards by manufacturers and importers, the issue of dumping poor quality non-medical face masks into the Malaysian market would be resolved.

Companies failing to comply with the regulations can be fined up to RM200,000 while individuals will face a fine of up to RM100,000 or imprisonment of up to three years or both, if convicted.

(Source: The Star)

Seriously, the question is why now especially after about 2 years of us using the face mask in the worse point of time we are now imposing a certification? Doesn’t it be too late to do this now considering we have very good choices and affordable non-medical face masks in our local pharmacy?

Tourists wearing masks during COVID 19 pandemic in Singapore Face Mask

Nowadays, no one can go out without putting on a face mask which was unthinkable before the pandemic. You can be fined and told off if you walk around without wearing any face mask. Image source: Victor He on Unsplash

Definition of Non-Medical Face Mask

The general definition is as follows:-

Non-medical masks are for the general public or use in non-healthcare related environments. They should be worn when there is low risk of exposure, outside of healthcare facilities, and/or when social distancing may be difficult.

In contrast, medical masks are designed as PPE for use in medical environments.

(Source: Primed)

And a more detailed one would be this:-

Non-medical masks are any kind of face coverings that aren’t N95 masks or surgical masks, which should be preserved for frontline workers and healthcare professionals.

Non-medical masks made from fabric can be bought from an increasing variety of vendors, from Etsy to Tanya Taylor to Frank and Oak. You can also make your own masks at home.

(Source: Chatelaine)

ASTM Face Mask Standard Quality

There are several types of standard in the world but usually, it follows ASTM or FFP standards which are used in the US, UK and European countries. In addition, each country may have their own standards to be met. Image source: Taiwan Masks

Standards For Non-Medical Face Mask

Since SIRIM is highlighted, one check at SIRIM’s website states this:-

Reusable masks are seen as a more economical and environmentally friendly alternative to disposable masks. They are generally used for non-medical purposes but should meet minimum requirements to protect the user from transmission of infectious agents.

Standards applicable for non-medical face masks are either SIRIM 40, CWA 17553 or AFNOR SPEC S76-001.

Relevant performance testing offered by SIRIM QAS includes Breathability, Microbial Test, Particle Filtration, Flame Spread, Cleaning and Ear Band.

(Source: SIRIM)

But then again, if you see some of the face masks sold in the local pharmacies, it also states ASTM level 3 which is another type of standard for non-medical face masks.

ASTM International is an organization that defines and sets standards for a variety of products, materials, systems, and services used by people performing their jobs every day. These standards are created to enhance performance of these work tools and improve lives by promoting quality and safety.

ASTM International is a global organization that is open to anyone who wants to help subject matter experts create or update standards; this collaborative nature helps keep standards as up-to-date as the industries who use them.

They have over 12,800 standards operating throughout the world, including those that cover personal protective equipment such as medical facemasks (e.g., ASTM F2100). The U.S. Food and Drug Administration (FDA) maintains a list of recognized standards, in which ASTM standards are included.

ASTM Level 1: Ideal for procedures in which there is low risk of fluid exposure (no splashes or sprays expected).

ASTM Level 2: Ideal for procedures in which there is moderate risk of fluid exposure (splashes or sprays can be produced).

ASTM Level 3: Ideal for procedures in which there is high risk of fluid exposure (splashes or sprays will be produced).

Wearing a facemask that has been ASTM-rated will ensure that your nose and mouth (breathing area) are protected against fluids, microorganisms, and particulates at the level to which the mask is rated (i.e., 1, 2, or 3 specifications). However, these masks do not provide protection again airborne diseases.

(Source: KDHEKS)

And this one is from UK and Europe in general (note: FFP stands for Filtrating FacePiece):-

Protective masks are designed to protect against particulates such as dust particles and various viruses in the air. These masks, unlike surgical masks, protect the wearer from inhaling infectious agents or pollutants in the form of aerosols, droplets, or small solid particles.

The wearer must be free of facial hair for this type of mask to be effective and should be ‘fit tested’ to ensure that the wearer has the appropriate, specific mask. These masks can be used in domestic, industrial and healthcare

The EN 149 standard defines three classes of filter efficiency for these masks:-

FFP1 – 80% filtering efficiency
FFP2 – 94% filtering efficiency
FFP3 – 99% filtering efficiency In the current COVID-19 situation, the World Health Organization (WHO) is recommending the minimum of an FFP2 mask for offering protection.

The NHS is stipulaating FFP3 in high-risk areas and FFP2 in lower-risk areas. In addition, masks are classified as single shift use only (marked NR on the product) or as re-usable i.e. more than one shift (marked R on the mask).

(Source: BSI Group)

It is good that the Domestic Trade and Consumer Affair

Final Say

s Ministry has quickly responded to the rumours on social media that consumers who don’t wear SIRIM certified non-medical masks will be fined RM100,000. It clarified:-

The “individuals” mentioned in the ministry’s official statement refer to personnel in the business of manufacturing and importing non-medical face masks and not members of the public.

(Source: NST)

Frankly speaking, at this point of the pandemic, we do not really need SIRIM certification as we already have international standards that most face mask manufacturers and importers have adhered to. The qualities of face masks have grown considerably and instead of the boring blue, we have now multiple coloured.

Further certification means additional cost to the manufacturing cost and this will translate to an increased cost of manufacturing. And this means increased selling price to the end consumers. If the government pursue certification, it should be done earlier to ensure quality 2 years ago and not now. Further considering most face masks already meet international standards, adding SIRIM certification will not make any difference.

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