The CE marking guarantees that the product complies with the legislation in force. If the mask is offered as sterile, in addition to other requirements, the number of the notified body which assessed the sterility conditions must be indicated.
The UNE EN 14683 standard guarantees compliance with the quality standard and includes the tests to be carried out for this type of mask which affect the following aspects: Breathability, splash resistance (for Type IIR), microbial cleaning and biocompatibility. This UNE standard specifies the values of each of the factors mentioned.
The same standard states that Type I surgical masks are not intended for use by healthcare professionals in an operating room or medical environment with similar requirements.
The type indicates whether the mask is type I or type II.
Being, moreover, a medical device, it must also provide:
- The name of the product.
- Name and address of manufacturer.
- Name of the representative and registered office.
- Package contents.
- Batch number and expiration date.
- Indicating, where applicable, that it is a single-use product.