What is a surgical mask?

Surgical masks are a single-use medical device, usually worn by health workers during healthcare procedures. These face masks were designed to protect the patient from contamination by the health professional. Recent evidence suggests that the protection works also the other way around, protecting the health worker from contamination by the patient.


Surgical masks are made of three layers of nonwoven fabric. The middle layer is made of meltblown, a filtering material. The two outer layers are made of spunbond, which can be splash resistant or not. If surgical masks have a colored side (for example blue or green), that is supposed to be the outer side, while the white side is in touch with the face.


During the Covid-19 pandemic, severe shortages on world markets of nonwoven fabrics (both meltblown and spunbond) have led to a dramatic increase in prices [insert article link], and manufacturers looking for alternative fabrics. Filtration levels of these alternative nonwoven fabric combinations can vary.


To make sure the limited availability of especially meltblown is used in fabrics that go to those people that need them (health workers), for the vast majority of healthy people that are not in touch with Covid-19 it has been recommended to use other types of masks. These are not surgical, are not medical devices, and are called a range of names, like hygienic masks, medical masks, or community face coverings. These masks look identical to surgical masks, are also made of other nonwoven fabrics that are less scarce than the ones needed for surgical masks. They are less strictly regulated, and filtration is lower. Read more here [insert article link].


Surgical masks in the EU are regulated by the norm EN 14683:2019+AC:2019, and are defined as Class I (lowest risk class) medical devices. Although to the general public they just seem both “face masks”, surgical masks (medical devices) are very different from FFP (personal protective equipment) from a regulatory standpoint. Both require CE certification.


In the EU norm, there are three types of surgical masks that differentiate themselves by bacterial filtration efficiency (BFE) and splash resistance.


Test Requirements and Performance Requirements

Test

Type I*

Type II

Type IIR

BFE - Bacterial filtration efficiency (%)

≥ 95

≥98

≥98

Differential pressure (Pa/cm²)

<40

<40

<60

Splash resistance pressure (kPa)

Not required

Not required

≥16,0

Microbial cleaningness (cfu/g)

≤30

≤30

≤30

*Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.


In the US, surgical masks are subject to the ASTM F2100 norm, and also divided in 3 categories based on filtration levels.

In China surgical masks are subject to the YY 0469 norm, while the “medical masks” or hygienic masks are subject to YY 0468 norm.

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