- Subversive discovery: Can lymph nodes promote the success of cancer immunotherapy?
- Major Discovery: Cancer cell PD-L1 does not inhibit T cell toxicity
- The new coronavirus may kill cancer cells and achieve a permanent cure!
- Why did the Alzheimer’s drug candidate BACE1 inhibitor fail?
- LRTI Death: Research spanning 80 years confirms for the first time
- The decline of the global antibiotic market is threatening the development of new drugs
What’s EN149 standard for masks?
- More than 1 million Chinese died after China quit “Zero-COVID policy”?
- Why is Vinyl chloride listed as a Class A “known human carcinogen” ?
- First human trial of HIV gene therapy: A one-time cure will be achieved if successful!
- New breakthrough in CAR-T cell therapy: Lupus erythematosus patients achieved treatment-free remission for up to 17 months
- How long can the patient live after heart stent surgery?
- First time: Systemic multi-organ recovery after death
Mask EN149 Standard is the CE standard designer to PPE against solids, water based aerosols and oil based aerosols. The main protection objects of dust masks are various types of 2113 particles.
The body of the mask 5261 is usually made of particle-proof 4102 filter material. It is fixed on the head by means of headbands, ear straps, etc., and is formed in the mouth and nose area of a person.
A space isolated from the polluted air, and the polluted air can only enter the respiratory tract after being forced by human inhalation through the filter material of the mask.
This type of mask usually has no parts that need to be replaced and needs to be discarded as a whole after failure.
It is also called disposable mask or maintenance-free mask, which is a type of half-mask respirator.
CE applicable standards for dust masks: EN 149:2001+A1:2009
- 1. Appearance
- 2. Material
- 3. Resistance test
- 4. Headband
- 5. Exhalation valve
- 6. Pretreatment
- 7. Respiration resistance
- 8. Leakage coefficient
- 9. CO2 concentration
- 10. Actual wear
Procedure to get CE certification of mask EN149 standard:
1. Confirm the standard of the product.
The EU standards for respiratory products are as follows:
BS EN 140: 1999 Half/Quarter Masks
BS EN 14387: 2006 Gas Filters & Combined Filters Air Filters and Combined Filters
BS EN 143: 2000 Particle Filters
BS EN 149: 2001 Filtering Half Masks to protect against particles
BS EN 136: 1998 Full Face Masks-Class 1, 2, or 3 Full Face Masks-Class 1, 2 or 3
2. Identify relevant instructions
After confirming the standards, you should find the EU directives or regulations corresponding to the product. Masks are personal protective equipment and have always belonged to the PPE directive. The European Union has recently upgraded the PPE directive, and a new regulation (EU) 2016/425. 2019 The new regulations (EU) 2016/425 have been enforced since 1999, ending the transition.
Personal protective equipment products are divided into 1-3 categories. Masks are products with high risk factors and are classified as three categories. Applying for CE certification requires factory audit. After obtaining the certificate, it also needs annual supervision and audit or testing to find Bestone.
3. Choose a qualified laboratory
After finding the directives or regulations and standards, it is to look for the EU Notified Body Laboratory, because personal protective equipment must be CE certified by the European Notified Body.
The test plan is formulated by the testing laboratory, and the samples that need to be prepared are also proposed by the laboratory. Generally speaking, FFP1, FFP2, FFP3, the three required masks need to be tested separately, and masks with valves need to be tested separately.
4. Test and review
Find a lab qualified for EN 149 tests on masks
5. Provide technical documentation
CE certification requires customers to provide a complete set of product technical documents, and each technical document of mask EN 149 will be reviewed according to the requirements of the PPE directive.
Chinese EN149 Labs
CCCMHPIE released the list of Chinese EN149 Labs on Aug 28 2020, which are approved by CNAS (China National Accreditation Service for Conformity Assessment) as qualified labs matching EU standard EN149/14683
Note: Scope of accreditation for some laboratories may be limited based on relevant standards. Further information is available at https://las.cnas.org.cn/LAS_FQ/publish/externalQueryL1En.jsp.