ISO 10993-5 & ISO 10993-10 Testings
There are two ISO 10993-5 & ISO 10993-10 testings which are critical when applying CE Registration.
In the market, most of consumers focus the percentage of BFE & VFE, Class / type of Face Mask, the product of origin….
EN14683 is International Standard for testing Face Mask Performance. The EU Country accept EN14683 Testing for Disposable Face Mask (Medical Device).
However, ATSMF2100 is one of American Standard for testing Face Mask Performance. The US accept this standard for Disposable Face Mask (Medical Device).
When manufacturer outside EU Country export the Disposable Face Mask, the manufacturer shall apply CE Registration and assign EU Representative before export.
When CE Registration, the Manufacturer is required to submit
- product information,
- material information,
- production information,
- Technical File,
- Clinical Report,
- Testing Report such as EN14683, ISO 10993-5 & ISO 10993-10 Testings.
As the ISO 10993-10 Testing involve animal testing, it take a longer time when comparing with the EN14683 Testing.
Now Face Mask market is highly competitive, so many manufacturer produce Face Mask with different colours and creative patterns.
For CE Registration , it is reminded that the manufacturer need to pay more for ISO 10993-5 & ISO 10993-10 Testing for each colour or patterns when exporting each colour or patterns Face Mask to EU Market.
ISO 10993-5 Testing for in vitro cytotoxicity
ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
ISO 10993-10 Testing for irritation and skin sensitization
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
- pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
- details of in vivo (irritation and sensitization) test procedures;
- key factors for the interpretation of the results
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EN 14683 Testing
EN14683 Testing include
- Bacterial Filtration Efficiency
- Breathability (Differential Pressure)
- Splash Resistance (for Type IIR)
- Microbial Cleanliness (Bioburden)
ASTM F2100 Testing
ASTMF2100 Testing include
- Barrier Testing
- Bacterial Filtration Efficiency
- Particulate Filtration Efficiency
- Splash Resistance
- Physical Testing
- Differential Pressure
- Safety Testing
- Flammability
