CE conformity of non-sterile medical masks
For non-sterile medical mask products, which are Class I medical devices, the issuance of certificates by notified bodies is not applicable. The standard notified bodies will not issue any form of CE certificate for Class I devices (non-sterile, without measurement function, and non-reusable).
The CE marking requirements for non-sterile medical masks include:
1) Prepare the technical documentation;
2) Complete the product testing;
3) Issue the declaration of conformity;
4) Appoint an European Authorized Representative;
5) Complete the registration with the EU competent authorities.
We have analyzed the positions of European competent authorities and buyers through some cases, so we can see that their focus is on stable product quality and legal procedures. Therefore, it is particularly important that:
1) Each product has a testing report, which shows that the testing result meets the standard requirements;
2) The manufacturer signs the declaration of conformity in accordance with 93/42/EEC;
3) The Chinese manufacturer has appointed an European Authorized Representative and completed the registration with the competent authorities of the EU member states;
4) The manufacturer has its own quality management procedures and methods to ensure stable and reliable product quality and avoid recalls.
As a service organization, we insist on:
1) Providing the product testing service in accordance with the EU standards at the cost prices to ensure reliable product quality and performance;
2) Providing the professional support and counseling for the preparation of technical documentation and declaration of conformity to ensure process compliance;
3) Actively communicating with the competent authorities of the EU member states to help customers complete product registration recording as soon as possible;
4) Patiently communicating with the European buyers and the competent authorities of the member states to perform the duties of the European Authorized Representative.
As a professional consulting agency, we can make you legal in terms of procedures through a series of standard operations, and we can also provide evidence that your product quality is up to standard through sample inspection, but the safe export of your products always relies on your product quality and management system. Every outstanding medical device manufacturer in China has gradually grown after experiencing countless audits by customers and third-party agencies and supervisions and inspections by regulatory agencies.
U.S. control requirements for medical surgical masks
Medical surgical masks seem to be very simple, the main components of which include the mask body, nose clip, and ear strap. The mask body is generally composed of three layers, namely the outer nonwoven fabric layer, the inner nonwoven fabric layer and the middle filter layer. The filter layer is usually made of melt-blown fabrics, as shown in Figure 1 and Figure 2.
So what are the technical requirements of the U.S. FDA for medical surgical masks? The requirements usually include two major aspects. One is the various filtration and protection properties of the product itself, including bacteria filtration efficiency, fluid splash penetration resistance, particulate filtration efficiency and other indicators, as shown in Figure 3. The other one is the biocompatibility of all materials. Generally speaking, the materials of the mask shall be safe, have no cytotoxicity and cause no skin irritation and allergy, as shown in Figure 4.
1. Filtration and protection properties
Figure 3 Requirements for filtration and protection properties
As can be seen from the above table, the performance requirements include:
1) Fluid splash penetration resistance: in the synthetic blood penetration test at 120mmHg pressure, at most 3 out of 32 samples are allowed to be penetrated; otherwise, the masks are considered unacceptable;
2) Particulate filtration efficiency PFE: use latex particulates with a size of 0.1μm to test the filtration efficiency, which shall reach 98% or more;
3) Bacterial filtration efficiency BFE: use 1700-2700CFU microorganisms and 3.0 ± 0.3μm particulates to penetrate the masks at an airflow rate of 28L/min and test the filtration efficiency, which shall reach 98% and above;
4) Respiration impedance Delta P test: this indicator reflects the breathability of the mask, and is usually tested together with the BFE; the purpose is mainly to control the risk of insufficient breathability caused by the manufacturer’s pursuit of high BFE;
5) Flammability: the standard puts forward requirements for the burning time of the product, which needs to be at least 3.5 seconds.
It can be seen that the protection provided by the medical surgical masks is mainly against the risk of splashing of the patient’s body fluid during surgical operation, the risk of bacterial infection, and the risk of droplet transmission of viruses. At the same time, it can also be seen that the technical requirements of the U.S. FDA for medical surgical masks are higher than those for medical surgical masks in China (YY0469-2011), and are similar to those for medical protective masks in China (GB19083-2010).
2. Material biocompatibility
Biocompatibility is a key indicator of material safety. Generally, for the products that are in contact with intact human skin, only three indicators need to be tested, namely, cytotoxicity, sensitization and skin irritation. However, for the different structural parts of the mask, due to their different materials, such as nonwoven fabrics, elastic ear straps, and plastic or metal nose clips, the materials need to be tested separately to provide evidence of safety. If the colors of the masks are different, the biocompatibility test also needs to be carried out separately, because different colorants may cause different biocompatibility. Therefore, its requirements are relatively strict.
Figure 4 Material biocompatibility
The above are the main technical requirements of the U.S. FDA for medical surgical masks. Of course, there are also requirements for product appearance, size, sterilization status, labeling, etc.
