Face Mask Testing and Certification
Face Mask Testing and Certification
Maintaining Safety and Reliability of Personal Protective Equipment.
About Face Mask Testing and Certification
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
Why SIRIM QAS International?
- Provide assurance of safety and reliability of your products with SIRIM QAS’s credible test report and SIRIM certification mark
- Ensure that your products are manufactured under an effective system of testing, supervision and control, reducing defects during production and mitigate unnecessary costs
- Gain consumer confidence and differentiate your products in the market by demonstrating product compliance with relevant standards
- Boost your brand reputation and enhance marketability on your certified products as a marketing tool
Application Process
Certification
- Enquiries
- Issuance of Quotation
- Application
- Document Evaluation
- Initial Audit
- Sample Selection and Testing
- Recommendation and Approval
- Purchase of SIRIM Label
- Surveillance Audit
- Renewal
Testing
- Submission of Test item
- Issuance of Quotation
- Product Testing
- Issuance of Test Report
Application Forms
Local Manufacturer
Trading Company for Foreign Manufacturer
Foreign Manufacturer
Please click here for other general information on product certification scheme.
For more information you may email to farihan@sirim.my , jailani@sirim.my or ramzi@sirim.my