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TEST FOR MASK

TEST FOR MASK
Medical environments are places where the risk of contamination of microorganisms is highest. Various measures are taken against the risk of such contamination in surgical interventions performed in hospitals and especially operating rooms. Wearing medical gloves and gowns are among these measures. In addition, medical face masks are also worn to protect from infectious diseases and various infective agents.
Masks are divided into different categories depending on their properties. It is expected to have different characteristics according to the place and purpose of use. Various tests are performed to determine and verify these properties. The current standard regarding the tests to be performed for medical face masks is the "TS EN 14683: 2019 + AC - Medical face masks - Requirements and test methods" standard.

Scope of TS EN 14683 Standard
We can list the items of this standard, which includes the test conditions for the mask, as follows:
1. Scope
2. Binding references
3.Terms and definitions
4. Classification
5. Requirements
5.1 General
5.1.1 Materials and construction
5.1.2 Design
5.2 Performance requirements
5.2.1 General
5.2.2 Bacteria filtration efficiency (BFV)
5.2.3 Breathability
5.2.4 Splash resistance
5.2.5 Microbial cleanliness level (Bioload)
5.2.6 Biocompatibility
5.2.7 Summary of performance requirements
6. Marking, labeling and packaging
Annex A (informative) Information for users
Annex B (binder) Method for in vitro determination of bacteria filtration efficiency (BFV)
Annex C (binding) Method for determining breathability (pressure difference)
Annex D (informative) Microbial cleanliness level
Annex ZA (for information) Relationship between essential requirements laid down in Directive 93/42 / EEC [1993 OJ L 169] intended to be covered by this European Standard

Relationship between Test Standard for Mask and Directive 93/42 / EEC "
The last part of the test standard for the mask is referred to the 93/42 / EEC directive. The information on which articles of the standard correspond to which requirements in the relevant directive is included. In this context;
• With the first sentence in section 8.1 of Directive 93/42 / EEC;
• We can say that the sections 5.1.1, 5.1.2, 5.2.2, 5.2.4, 5.2.5, 5.2.6 of the test standard for the mask are interrelated.
Within the scope of the test for the mask in the relevant articles of the standard;
• durability during use
• ensuring a perfect fit
Bacterial filtration efficiency
Splash resistance where appropriate
• microbial cleanliness level (biochar)
We can say that their subjects match with the 93/42 / EEC directive.

Other Regulations Regarding Test Standards for Mask
Although the EN 14683 standard is a standard accepted as valid within the scope of the test for the mask, different standards have also been referred to. These standards are:
• EN ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1: 2009)
• EN ISO 11737-1: 2018, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1: 2018)
ISO 22609: 2004, Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

Tests for Masks within the Scope of EN 14683
We can list the tests required for a mask in the standard as follows:
Bacteria filtration efficiency (BFV)
• Breathability
Splash resistance
Microbial cleanliness level (Bioload)
Biocompatibility
Experiment Type I Type II Type IIR
Bacteria filtration efficiency (BFV), (%) ≥ 95 ≥ 98 ≥ 98
Pressure difference
(Pa / cm2) <40 <40 <60
Splash resistance
pressure (kPa) Not required Not required ≥ 16.0
Microbial cleanliness level (kob / g) ≤ 30 ≤ 30 ≤ 30

During the COVID-19 pandemic process we are in, it is obligatory to wear masks especially in closed and public areas. Type I face masks are also the type of mask that patients and other people should wear in such epidemics. These masks are not suitable for professional healthcare professionals and are not suitable for use in operating rooms and other surgical settings.
The mask type determined as a result of the tests for the mask must also be specified when the product is offered for sale. As a requirement of the 93/42 / EEC Medical Devices Directive, the test standard number for the mask (EN 14683) and the type information of the mask must be included on the product.

Test Applications for Mask
Mask manufacturers should work with test laboratories that have obtained the necessary accreditation to document their products and perform the tests specified in the standard. Companies that want to obtain CE Certificate for the mask must also have these tests, which are a requirement of the 2016/425 / EU Personal Protective Equipment and / or 93/42 / EEC Medical Devices Directives.
 

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