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The Type IIR Medical Face Mask is intended to be used in operating rooms and health care settings with similar requirements are designed to protect the entire working environment. This standard describes two types of medical face masks with associated protection levels. As a minimum:
A.Type I medical face masks are used for patients to reduce the risk of the spread of infections, particularly in epidemic or pandemic situations.
B.Type II masks are principally intended for use by healthcare professionals in an operating room or other medical settings with similar requirements.
Medical face masks specified in this European Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. The 'R' signifies splash resistance.
When tested in accordance with Annex B, the BFE of the medical face mask shall conform to the minimum value given for the relevant type in Table 1.
When tested in accordance with Annex C, the differential pressure of the medical face mask shall conform to the value given for the relevant type in Table 1.
When tested in accordance with ISO 22609:2004 the resistance of the medical face mask to penetration of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1.
When tested according to EN ISO 11737-1:2018 the bioburden of the medical mask shall be ≤ 30 CFU/g tested (see Table 1).
According to the definition and classification in EN ISO 10993-1:2009, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993-1:2009 and determine the applicable toxicology testing regime. The results of testing should be documented according to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request.
|Test||Type I a||Type II||Type IIR|
|Bacterial filtration efficiency (BFE), (%)||≥ 95||≥ 98||≥ 98|
|Different pressure (Pa/cm2)||< 40||< 40||< 60|
|Splash resistance pressure (kPa)||Not required||Not required||≥ 16,0|
|Microbial cleanliness (cfu/g)||≥ 30||≥ 30||≥ 30|
|a Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in an epidemic or pandemic situation. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements|
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