Medical surgical masks are grouped into two main groups, Type I and Type II, based on bacterial filtration efficiency. According to its resistance to splash, it is divided into Type II or Type IIR. There are separate requirements for each type.
Medical surgical face masks are designed to be used in operating rooms, in environments where health services are provided with requirements similar to medical environments, or to protect the entire working environment. The EN 14683 standard defines two types of medical surgical face masks with associated levels of protection. As a minimum, Type I medical face masks are used for patients to reduce the risk of spread of infections in the community, especially in epidemic or pandemic situations. Type II masks are primarily intended for use by healthcare professionals in an operating theater or other medical environment with similar needs.
All performance tests must be carried out on the final product or the part taken from the final product. In this case, the tests made on the raw material do not guarantee that the mask purchased ultimately meets the requirements of the standard.
EN 14683 Performance tests; In vitro assessment of bacterial filtration efficiency (BDE), air permeability (differential pressure), microbial cleaning, splash resistance according to ISO 22609: 2004 standard (for Type IIR masks) and biocompatibility tests. All performance tests should be as in table 1.
Regarding microbial cleaning, the biological load of the mask should be evaluated according to Annex D of ISO 14683 standard or EN ISO 11737-1 standard.
In addition, the relevant tests and / or evaluation specified in table A.1 in EN ISO 10993-1 standard must be performed on the masks. Considering the place and duration of the contact with the body, the necessity of physical and chemical evaluation, cytotoxicity, irritation and sensitization tests emerge.
The level of efficiency a mask offers depends on a number of factors such as filtration efficiency, material quality, and fitting the mask on the wearer’s face. Different designs are suitable for different applications and therefore careful mask selection is important to achieve the desired result.
All medical surgical masks should be manufactured in a suitable controlled environment and their biological load should be kept under control.
Medical masks should not be torn, split or torn during normal use. Care should be taken to clean the filters that will be used for masks. The compatibility of the medical mask with the body is important. For this reason, it should be paid attention that it is designed to include mouth, nose and chin.
Masks can also be evaluated as Personal Protective equipment according to their intended use. You can reach our article about how this evaluation will be by clicking here.
Medical surgical masks that are not sterile are classified as class I according to 93/42 / EC directive. Accordingly, after producing the masks in suitable and controlled environments, the manufacturer should prepare the technical file of the product after creating the necessary production and quality control infrastructure, and this file should contain documents that demonstrate compliance with the basic safety requirements of this regulation. This documentation should also include a risk assessment based on the EN ISO 14971 standard. Final products should be tested according to EN 14683 standard. After these steps have been passed, the manufacturer must prepare his own declaration of conformity and keep his technical file.
Medical surgical face masks in sterile condition are classified as Class I devices (class Is) according to 93/42 / EC directive. In this case, in addition to the above steps, a notified body certified in Directive 93/42 / EC will require certification.
In addition to medical surgical face masks that are not sterile, masks produced in a controlled environment should be subjected to a sterilization agent and sterilization validation should be performed. This validation ensures the suitability of the sterilization method applied.
Based on ISO 13485 requirements, a quality management system, including the requirements of 93/42 / EC regulation, should be established and operated.
After applying with the technical file prepared for the Notified Body, this organization carries out a series of field inspections and technical documentation examinations and, if the final result is appropriate, gives the document called “EC Certificate” and the Accredited ISO 13485 certificate. The manufacturer signs the declaration of conformity with the 93/42 / EC certificate and can put his products on the market.
Szutest is a notified member of Team-NB under 93/42 / AT regulation. In the ISO 13485 standard, the Turkish Accreditation Agency has TÃœRKAK accreditation.