Non-medical Face Masks

The Domestic Trade and Consumer Affairs Ministry gazetted Trade Descriptions (Certification and Marking of Non-Medical Face Mask) Order 2022. (download below)

The order will take effect on 1st January 2023 to ensure that non-medical face masks, whether produced locally or imported, comply with the set safety standards. The manufacturers and importers of non-medical face masks must apply for MS SIRIM certification and marking from SIRIM.

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 includes:

• Breathability
• Microbial Test
• Particle Filtration
• Flame Spread
• Cleaning
• Ear Band

Respiratory Protective Devices

Respirators are tight-fitted masks designed to protect the users against particles which include gases, dust, droplets and aerosols.

This type of masks are normally used in various industrial sectors and can be considered as Non-Medical Face Mask as well. SIRIM can test and certify on various types of respirators based on relevant standards such as MS 2323 or BS EN 149.

Medical Face Masks

Medical face masks are used by healthcare professionals and patients to protect them from exposure to infections, blood and bodily fluids.

Under Medical Device Act 2012 (Act 737), a medical device must be registered under the Act before it can be imported, exported or placed in the market.

Applicants may apply SIRIM Product Certification to put SIRIM label on the product as a form of quality recognition in the eyes of general public.

There are three types of medical face masks:

• Type I are used for patients in order to reduce the risk of the spread of infections, especially during pandemics and epidemics.
• Type II are used by healthcare workers and front liners for similar intended purposes when contact to blood or bodily fluids are not at risk.
• Type IIR are appropriate for use by healthcare professionals where exposure to blood and/or bodily fluids are at risk.

SIRIM is capable to carry out testing for all the above types of medical masks based on international standard BS EN 14683, which covers:

• Bacterial Filtration Efficiency (BFE)
• Differential Pressure
• Splash Resistance Pressure (Synthetic Blood)
• Microbial Cleanliness (Bioburden)
• Biocompatibility

SIRIM may also certify to other equivalent medical face masks standard such as ASTM F2100.

Downloads