Surgical Mask Testing for Manufacturers

Perform all the necessary tests for medical face mask validation with Lifeanalytics

Would you like to test the medical device biocompatibility requirements of your surgical masks?

Thanks to the new Abich – Lifeanalytics' Competence Center, the medical device testing service to meet biocompatibility requirements is at your disposal.

Health and personal protection are two fundamental aspects in both private and work life, and may depend on the filtration efficiency of face masks.

The Personal Protective Equipment (PPE) has never been as important as it is now: indeed, it must be worn in many settings.  For face masks to be effective, they need to comply with strict standards proving not only that they effectively block bacteria and viruses but also that their materials are clean and that they have an adequate degree of breathability.

Get quality and safety in full compliance of current regulations. The experts of Lifeanalytics, which is part of an Italian and international network of accredited laboratories, are at your service to guarantee that your products comply with current regulations and are effective when they are marketed.

What tests need to be carried out on surgical masks?

Tests for construction, design, performance requirements and test methods for medical face masks as envisaged in the technical standard UNI EN 14683:2019 ‘Requirements and test methods’

  • Determination of Bacterial Filtration Efficiency (BFE) UNI EN 14683:2019 Annex B
  • Determination of breathability (Differential pressure) UNI EN 14683:2019 Annex C
  • Determination of splash resistance or Splash Test ISO 22609:2004 ‘Clothing for protection against infectious agents – Medical face masks – Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)’
  • Microbial cleanliness (Bioburden) UNI EN 14683:2019 par. 2.5 + Annex D

Medical device biocompatibility requirement testing as envisaged in the technical standard UNI EN ISO 10993-1:2021 – ‘Biological evaluation of medical devices

  • Biological evaluation (bibliographic research) ISO 10993-1
  • Chemical characterisation ISO 10993-18:2020
  • Cytotoxicity ISO 10993-5
  • Skin irritation ISO 10993-10 and OECD 439
  • Skin sensitization ISO 10993-10

Air Permeability Test according to ISO 9237:1995 Determination of the permeability of fabrics to air.

  • Determination of the permeability of materials and/or surgical masks to air ISO 9237:1995
  • Determination of the breaking load and extension of materials and/or surgical masks ISO 9237:1995

Lifeanalytics, your safest choice

Make sure you have the best partner for your tests: Lifeanalytics is a group of highly-specialised laboratories. An Italian excellence with several certifications that bases its work on an extremely high quality of analytical data and testing speed.

Request a tailor-made consultation by filling in the contact form.

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