What is EN 14683:2019 – Medical face masks – Requirements and test methods?
EN 14683:2019-Medical face masks, is a European standard, It provides specifications and testing procedures for medical face masks, ensuring their safety and performance in healthcare settings.
The standard establishes requirements for several aspects of medical face masks, including design, materials, construction, performance, and labeling. It aims to ensure that medical face masks effectively protect healthcare professionals and patients from potential hazards, such as airborne particles and bodily fluids
Here are some key aspects of the standard
Bacterial filtration efficiency (BFE): This measures the mask’s ability to filter bacteria and is assessed through laboratory testing.
Particle filtration efficiency (PFE): This evaluates the mask’s filtration capacity for airborne particles, such as dust or droplets.
Breathability: The standard sets limits on the resistance of the mask to airflow, ensuring that users can breathe comfortably while wearing it.
Splash resistance: This tests the mask’s resistance to penetration by liquid splashes, simulating potential exposure to bodily fluids during medical procedures
Microbial cleanliness: It specifies requirements for the microbial cleanliness of the masks, addressing potential contamination issues.
Biocompatibility: The standard outlines criteria for the evaluation of potential skin irritations and other adverse reactions caused by the materials used in the mask.
Marking and labeling: EN 14683:2019+AC:2019 provides guidelines for the proper marking and labeling of medical face masks, including information on their performance characteristics and compliance with the standard.
Manufacturers who adhere to the standard demonstrate their commitment to producing high-quality medical face masks that meet certain safety and performance requirements.
Requirements of EN 14683:2019+AC:2019 – Medical face masks
Design and construction:
- The mask should have a three-layer structure, consisting of an outer layer, a filtration layer, and an inner layer.
- The materials used should be free from substances that could cause harm to the wearer or patients.
- The mask should have ear loops or ties for secure attachment to the wearer’s face
Bacterial filtration efficiency (BFE):
- The mask should demonstrate a minimum BFE of 95% or higher, indicating its ability to filter bacteria.
- BFE is determined through laboratory testing using aerosolized bacteria
Particle filtration efficiency (PFE):
- The mask should have a minimum PFE of 95% or higher, indicating its ability to filter airborne particles.
- PFE is determined through laboratory testing using aerosolized particles
Breathability:
- The mask should have a differential pressure of <40 Pa/cm², indicating its breathability.
- Differential pressure is determined by measuring the air pressure difference across the mask
Splash resistance:
- The mask should demonstrate resistance to penetration by synthetic blood or other liquid splashes.
- Splash resistance is evaluated through laboratory testing using synthetic blood or liquid aerosols
Microbial cleanliness:
- The mask should meet specified microbial cleanliness requirements to ensure it is free from microbial contamination.
- Microbial cleanliness is determined by assessing the number of viable microorganisms present on the mask
Biocompatibility:
- The materials used in the mask should be biocompatible, meaning they do not cause adverse reactions on the skin or other tissues
Marking and labeling:
- The mask should be properly marked and labeled, including information such as the manufacturer’s name, mask type, performance levels (BFE, PFE), and compliance with the standard
Benefits of EN 14683:2019+AC:2019 – Medical face masks
Enhanced safety: The standard sets specific requirements and test methods to ensure that medical face masks provide a certain level of protection for healthcare professionals and patients. By complying with the standard, manufacturers can produce masks that reduce the risk of exposure to airborne particles, bacteria, and liquid splashes.
Consistent quality: It establishes uniform requirements for the design, construction, and performance of medical face masks. This promotes consistency in the quality of masks produced by different manufacturers. Users can have confidence that masks meeting this standard will provide a certain level of filtration efficiency and breathability.
Filtration efficiency assurance: The standard specifies minimum requirements for bacterial filtration efficiency (BFE) and particle filtration efficiency (PFE). This ensures that medical face masks effectively filter out bacteria and airborne particles, reducing the potential transmission of infections in healthcare settings.
Comfort and breathability: EN 14683:2019 includes requirements for the breathability of masks, setting limits on the resistance to airflow. This ensures that masks allow for comfortable breathing, minimizing discomfort and respiratory burden for the wearer.
Protection against liquid splashes: The standard includes tests for splash resistance, assessing the mask’s ability to withstand penetration by liquid splashes, such as blood or other bodily fluids. This feature is especially important in medical environments where there is a risk of exposure to such liquids during procedures.
Biocompatibility assurance: This standard addresses the biocompatibility of the materials used in medical face masks. This helps to ensure that the masks are safe to use and do not cause adverse reactions or skin irritations when in contact with the wearer’s skin.
Standardization and regulatory compliance: Compliance with EN 14683:2019+AC:2019 allows manufacturers to demonstrate their adherence to recognized standards and regulations. This helps in gaining market acceptance and regulatory approval for the masks, both within the European Union (EU) and in other regions that recognize or adopt similar standards.
Overall, EN 14683:2019-Medical face masks supports the production of high-quality medical face masks that offer reliable protection, comfort, and performance, contributing to the overall safety of healthcare professionals and patients.
Document checklist for EN 14683:2019-Medical face masks
Technical File: This is a comprehensive document that includes all relevant technical information about the medical face masks. It typically consists of the following:
- Design and construction details
- Material specifications and compliance
- Manufacturing processes and quality control procedures
- Test reports and results demonstrating compliance with the standard’s requirements
- Labeling and instructions for use
- Biocompatibility assessment reports
- Evidence of conformity to essential health and safety requirements
Test Reports: These reports provide the results of various tests conducted on the medical face masks. The tests may include:
- Bacterial filtration efficiency (BFE) testing
- Particle filtration efficiency (PFE) testing
- Differential pressure testing for breathability
- Splash resistance testing
- Microbial cleanliness testing
- Biocompatibility testing
Declaration of Conformity: This is a document issued by the manufacturer or authorized representative declaring that the medical face masks comply with the requirements of EN 14683:2019+AC:2019. It typically includes:
- Manufacturer’s details (name, address, etc.)
- Product identification and description
- Reference to the standard (EN 14683:2019-Medical face masks)
- Statement of conformity
- Signatures and dates
Labeling and Instructions for Use: The medical face masks should be properly labeled with the necessary information. This may include:
- Manufacturer’s name and address
- Mask type and model identification
- Performance levels (BFE, PFE)
- Batch or lot number
- Instructions for proper use and disposal
- Cautionary statements or warnings
Manufacturing and Quality Control Documentation: This includes documentation related to the manufacturing processes and quality control procedures in place. It involves:
- Standard operating procedures (SOPs) for manufacturing
- Material specifications and supplier information
- Quality control records and test data
- Calibration and maintenance records for equipment
- Records of internal audits and corrective actions
Who needs EN 14683:2019+AC:2019 – Medical face masks – Requirements and test methods?
Manufacturers: Manufacturers of medical face masks need to adhere to EN 14683:2019+AC:2019 to ensure the quality, safety, and performance of their products. Compliance with the standard helps manufacturers demonstrate that their masks meet the necessary requirements and provide an appropriate level of protection in healthcare settings.
Regulatory Authorities: Regulatory authorities, such as health authorities or medical device regulatory bodies, may require compliance with the standard as part of the approval or registration process for medical face masks. This ensures that the masks meet recognized standards and regulations before they can be marketed or used in healthcare settings.
Certification Bodies: Certification bodies may offer certification services for medical face masks based on this standard. Manufacturers can seek certification from these bodies to obtain official recognition that their masks meet the requirements of the standard. Certification provides additional assurance to customers and regulatory authorities about the quality and performance of the masks.
Healthcare Facilities: Healthcare facilities, including hospitals, clinics, and long-term care facilities, may require medical face masks that comply with the standard. These facilities prioritize the use of masks that meet recognized standards to ensure the safety and protection of healthcare professionals, patients, and visitors.
Distributors and Suppliers: Distributors and suppliers of medical face masks may prefer to source products that comply with this standard. Compliance with the standard ensures that the masks meet specific quality and performance requirements, which can enhance the reputation and trustworthiness of the products among customers.
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