SIRIM FACE MASK TESTING (MEDICAL AND NON MEDICAL)

 

SIRIM QAS is ready to assist manufacturers and suppliers meet increasing demand for quality and safe products in the market. Our testing and certification cover a wide range of face masks and respirators, helping companies to ensure product compliance with national and international standards.

Face masks and respirators are expected to provide essential protection to the user from any infectious agents or hazardous airborne particles. Apart from application in the healthcare and industrial sectors, the use of masks for the public becomes imperative during haze, pandemics and epidemics.

Substandard quality of masks therefore could cause a serious risk to the public health and safety.  Therefore, testing and certification can help ensure standards of quality are maintained by manufacturers and suppliers of these products.

SIRIM QAS is a one-stop centre for testing and product certification for face masks. We have the expertise and capabilities to perform testing on a wide range of face masks and respirators based on relevant international standards. 

Product certification with SIRIM QAS is proof that the products you put out in the market are of superior quality, and grants you a competitive edge in the PPE industry. This also enables acceptance of your products to international markets through compliance with national requirements.

Scope of Services

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 here) 

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 QAS International Sdn. Bhd.

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.

Respiratory Protective Devices

Respirators are tight-fitted masks designed to protect the users against particles which include gasses, 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 QAS can test and certify on various types of respirators based on relevant standards e.g 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) requires a medical device to be registered under the Act before it can be imported, exported or placed in the market (www.mda.gov.my).  In addition, applicant may apply SIRIM Product Certification to put SIRIM label on the product as 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

1/2/3 ply masks are Type I medical face masks that have a lower bacterial filtration efficiency compared to Type II masks. Type IIR medical masks have similar applications as Type II but carry additional properties of splash resistance.

SIRIM QAS is capable to carry out testing for all the above types of medical masks based on the 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 e.g. ASTM F2100

Application Process

Certification

1. Enquiries
2. Issuance of Quotation
3. Application
4. Document Evaluation
5. Initial Audit
6. Sample Selection and Testing
7. Recommendation and Approval
8. Purchase of SIRIM Label
9. Surveillance Audit
10. Renewal

Testing

1. Submission of Test item
2. Issuance of Quotation
3. Product Testing
4. Issuance of Test Report

Application Forms

Local Manufacturer

• Product Certification Application Form
• Declaration of Approval from Relevant Authority
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation Letter of Trade Mark (if applicable)

Trading Company for Foreign Manufacturer

• Product Certification Application Form
• Declaration by Manufacturer
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation Letter of Trade Mark (if applicable)

Foreign Manufacturer

• Product Certification Application Form
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation letter of Trade Mark (if applicable)