The latest version of the EN 14683 standard, which is EN 14683:2019+AC:2019, was issued by the European Committee for Standardization (CEN). The CEN is a standardization organization that develops voluntary standards for products, services, and processes across various industries in Europe.
The EN14683:2019+AC:2019 supersedes the previous version of the standard, which was EN 14683:2014. The new version includes updates to the requirements and test methods for medical face masks, as well as changes to the labeling and packaging requirements. These updates were made to improve the quality and effectiveness of medical face masks and to ensure their conformity with regulatory requirements.
The EN14683 standard sets requirements for various aspects of the masks, including their design, materials, and performance. It also specifies test methods for evaluating the masks’ performance, such as bacterial filtration efficiency, breathability, and splash resistance.
Compliance with the EN14683 standard is important for ensuring the quality and effectiveness of medical face masks in protecting against the spread of infectious diseases.It specifies requirements and test methods for various aspects of the masks, including:
- Design and performance: The standard defines several types of masks, including Type I, Type II, and Type IIR, based on their effectiveness at filtering bacteria and other particles. The masks must also meet certain requirements for breathability, splash resistance, and microbial cleanliness.
- Materials: The standard specifies requirements for the materials used in the masks, such as the filter material, the straps, and the nose clip. The materials must be safe and non-toxic, and they must not cause irritation or allergic reactions.
- Marking and labeling: The masks must be marked and labeled with certain information, such as the type of mask, the manufacturer’s name and address, and the date of manufacture.
- Testing: The standard specifies several test methods for evaluating the masks’ performance, such as bacterial filtration efficiency, breathability, and splash resistance. The masks must meet certain performance criteria to be considered compliant with the standard.
Compliance with the EN14683 standard is important for ensuring the quality and effectiveness of medical face masks in protecting against the spread of infectious diseases.