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Mask Differential Pressure (Breathability) Test

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Mask Differential Pressure (Breathability) Test

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Service Scope

From public transport to intensive care units, personal protective equipment (PPE) has never been more important. Protecting people from virus is the number one priority for individuals, businesses, organizations and governments. Face masks are now compulsory in many settings. 

Our testing and certification services verify your product’s effectiveness and compliance with those regulations relevant to the US & Europe markets.  

The test will be conducted in compliance with the following standards according to the selected market 

  • ASTM F2101 
  • ASTM F2100 
  • EN 14683 

SGS can offer testing and certification services to verify your product’s Mask Differential Pressure (Breathability) and compliance with those regulations relevant to the US & Europe markets. 

Test Plan

Sample Size 
It will be advised in order confirmation email upon purchase

Turnaround Time (working days)
10 Days

Test Description

Table below is the overall requirements for US ASTM F2100 & Europe EN 14683 and this package will perform Differential Pressure (Breathability) according to the selected market 

ASTM F2100 Classification 

Table 1 Medical Face Mask Material Requirements by Performance Level

Characteristics
Level 1 
Barrier
Level 2
Barrier 
Level 3
Barrier

Bacterial filtration efficiency [%]

≥ 95

≥98

≥98

Differential pressure [mm H2o/cm]

<5.0

<6.0

<6.0

Sub-micron particulate filtration efficiency at 0.1 micron [%]

≥ 95

≥ 98

≥ 98

Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result#

80

120

160

Flame spread

Class 1

Class 1

Class 1

*-An acceptable quality limit of 4.0% is met for a single sampling plan when 29 or more of the 32 tested specimens show “pass” result.

EN 14683 Classification 

Table 1 Performance requirements for medical face masks

Characteristics
Type IType IIType IIR

Bacterial filtration efficiency [%]

≥ 95

≥98

≥98

Differential pressure [Pa/cm2]

<40

<40

<60

Splash resistance [kPa]#

Not Required

Not Required

Not Required

Microbial cleanliness (cfu/g)

≤30

≤30

≤30

*Type I medical face masks should only be used for patients and other persons to reduce the risk of spreading 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.

#-An acceptable quality limit of 4.0% is met for a single sampling plan when 29 or more of the 32 tested specimens show “pass” results.

Remarks

Only applicable test items will be conducted on selected product nature and destination market. A detailed test item list will be included in order confirmation email upon order purchase.

Strengths & benefits


Regulatory Experts
Ensure your product compliance to specific countries’ requirements


Global Network
Provide worldwide coverage and access to all key locations & markets

Order flow

1. Check Out

Confirm selections and fill in contact info

2. Arrange Payment

Pay by credit card or bank transfer offline​

3. Confirm Test Plan

Confirm test and product details

4. Send Sample

Send the sample with printed form

5. Receive Report

Receive our test report by email

Payment

Online Payment
  • We accept VISA, MASTERCARD and AMERICAN EXPRESS
  • Order acknowledgment email will be sent to you by system after successful payment
  • Order confirmation email with service details will be sent to you within 1 working day by our specialist
Offline Payment
  • We accept T/T bank transfer payment
  • Order acknowledgment email with bank details for payment will be sent to you by system after order submission
  • Please arrange payment and send payment receipt to our specialist by email
  • Order confirmation email with service details will be sent to you after payment verification by our specialist

FAQs

You can add them to shopping cart and proceed to checkout for placing your order online. You will receive an order acknowledgment with order details after online order.

It is not necessary to create an account for online purchase, you can select Guest Checkout to place an order without an account.

However, creating an account offers additional benefits:

  • Your contact information will be saved securely for a faster checkout
  • Track your order status and history

If you place an order as a guest, please check our notifications at your email box. Please remember to check promotional and junk mail box if you can’t find it.

If you place an order as a member, please log in and check the status of your order under “Quote Request” or “Orders”.

SGS TIC Mall only accepts US$ for checkout.

You will receive a test application form, sample requirement and delivery details in confirmation email upon successful payment, please complete the form and send the required sample(s) to our competence center in Hong Kong.

Please contact your dedicated specialist to submit your request. It will be reviewed case by case depending on the order process.

No, you can’t cancel and refund the paid order unless there is a quality or service delivery issue.

Surgical masks meeting ASTM Level 2 or Level 3 will be able to filter ≥98% bacteria and 0.1μm particulates, while ASTM Level 1 can only filter ≥95% bacteria。 

EN14683 Type I and Type II can filter ≥95% and ≥98% bacteria, Type I has a higher breathability than Type II, both are non-resistant to fluid. Type IR has the same bacteria filtration efficiency as Type I, just as Type IIR and Type II, but Type IR are resistant to fluid. 

“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing to get an approval. FDA approval is usually mandatory when you market or sell the products in the US that might have a significant risk of injury or illness, but can also benefit your health — such as prescription medications, over-the-counter medications, vaccines and Class III medical devices. 

Class II and Class I medical devices are usually “cleared” by the FDA – meaning the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has an FDA clearance or approval. Companies must submit a “premarket notification submission” or 510(k) to the FDA so that they can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is “cleared,” and can be marketed and sold in the US. 

Since the surgical mask is classified as class I medical device, the company has to submit premarket notification 510(k) before they can be sold in the US market.  

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