In the detection of the quality of the mask on the standard of ce, only through the ce of the mask quality is relatively good, but also more pop
In the detection of the quality of the mask on the standard of ce, only through the ce of the mask quality is relatively good, but also more popular, the following we take a look at the mask through the ce of the mask is what masks?
In the EU market "CE" mark is a mandatory sign, whether it is a product produced by enterprises within the EU, or products produced in other countries, in order to circulate freely in the EU market, must be affixed with the "CE" mark to indicate that the product is in compliance with the EU's "New Technology Harmonization and Standardization". The CE marking is required to show that the product complies with the basic requirements of the EU Directive on Technical Harmonization and New Approaches to Standardization.
With the CE abbreviation for the symbols that affix the CE marking of the product meets the main requirements of the relevant European directives (Essential Requirements), and to confirm that the product has passed the appropriate conformity assessment procedures and manufacturers of qualified statements, the real products are allowed to enter the European **** body market sales passport.
CE mark is not a quality mark, it is a representative of the product has been in line with the European safety/health/environmental protection/hygiene and other series of standards and directives of the mark. The CE marking is mandatory for all products sold in the European Union.
How to see if the mask has ce
Many people look at the quality of the mask are good to see if the mask has gone through the ce, but life many people do not know how to see if the mask has ce, the following small make-up will be for you to say a little bit more about this problem.
1, mask ce in the upper right corner of the mask will have a letter print, or mask bags also have CE icon.
2, mask CE is a recent popular product, is mandatory for export to EU countries. Masks in Europe belongs to the Personal Protection Directive product category 3 products (safety level is very high), based on the European standard is EN149.
3, there are two modes: (1) send samples each year to the European masks laboratory test, submit a complete quality system of technical documents, as well as drawings, factory test reports and other documents, if the documents are complete, the European Union agency personnel can not be on your factory If the documents are complete, the personnel of EU organization may not audit your factory on the spot. (2) annual samples sent to the European laboratory test, plus two times a year, the factory audit, many organizations only accept the second kind of application, because the second kind of organization is more assured.
4, there is a possibility that if your company's mask is used in hospital settings, it does not belong to the scope of personal protection, belongs to the scope of medical devices, to do MDD directive.
Ce standards for disposable medical masks
Disposable medical masks are widely used whether in the medical field or in life, for the quality of the masks we are very concerned about, then today we will take a look at the ce standards for disposable medical masks.
Medical masks EN14683 standard divides masks into three categories: type I, type II, type IIR.
Testing standard requirements include: bacterial filtration efficiency, pressure difference, resistance to synthetic blood permeability, biological cleanliness. Details of different types of medical masks are as follows:
Type I: bacterial filtration efficiency ≥95, pressure difference (Pa/cm) 40, resistance to synthetic blood permeability (pressure kPa) no requirement, biological cleanliness (cfu/g) ≤30;
Type II: bacterial filtration efficiency ≥98, pressure difference (Pa/cm) 40, resistance to synthetic blood permeability ( Pressure kPa) no requirement, biological cleanliness (cfu/g) ≤ 30;
Type IIR: bacterial filtration efficiency ≥ 98, pressure difference (Pa/cm) 60, permeability against synthetic blood (pressure kPa) ≥ 16, biological cleanliness (cfu/g) ≤ 30.