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2020 4 25 · Since surgical masks are considered class I medical devices, the manufacturer must perform a risk analysis and additional tests if necessary to respond to the European Medical Device Directive 2017/745. There is no requirement for the barrier against inert particles. TÜRCERT mask CE document supports all medical and medical device manufacturers.
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2020 2 11 · All Class 1 Medical Devices can affix CE Mark by self declaration by preparing a Declaration Of Conformity and complying with other requirements. But majority of the manufactures still depend on a third party Certification to get a reputed CE Certificate. [b] Class I Sterile Devices
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