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Mask Microbial Cleanliness (Bioburden) Test

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Mask Microbial Cleanliness (Bioburden) 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, business, organizations and governments. Face masks are now compulsory in many settings. 

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

  • EN 14683 

SGS can offer testing and certification services to verify your product’s Mask Microbial Cleanliness (Bioburden) and compliance with those regulations relevant to the Europe market. 

Test Plan

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

Turnaround Time (working days)
12 Days

Test Description

Table below is the overall requirement for Europe EN 14683 and this package will perform Microbial cleanliness according to the selected market :

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 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.

#-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. Detailed test item list will be included in order confirmation email upon order purchase. If the battery is included, additional battery requirements shall be arranged.

Strengths & benefits


Regulatory Experts
Ensure your product compliance to specific countries requirement


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.

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Top search:
REACH Annex
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Disinfection
GB 18401
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EN 71-1
Mask

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