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Hygienic Face Mask Certification

Hygienic Face Mask Certification

AENOR has strengthened diverse lines of action to boost our country's capacity to respond to the crisis caused by COVID-19.

The AENOR Hygiene Face Mask Certification offers a guarantee of trust against the spread of the virus during the pandemic. Trust for all those using, distributing and manufacturing face masks, thanks to meeting a series of compliance check processes in line with UNE specifications.

  • Sanitary face masks are NOT medical products (like surgical face masks are), which means they do not need to be licenced by the AEMPS (the Spanish Agency of Medicines and Medical Devices).
  • Hygiene face masks are not PPE (personal protective equipment that protects workers from different risks), which means they do not need the CE marking for sale on the common European market.
  • Hygiene face masks are designed for asymptomatic children/adults/workers not required to wear surgical face masks or particle-filtering face masks, and always subject to appropriate risk assessment.
  • Hygiene face masks are effective in low-risk contagion settings, which are most environments except healthcare and the socio-sanitary field.

Certification

Inspection

Conduction of product audits at source and auditing of pre-shipment inspection healthcare material and protection processes when manufactured in countries outside Spain (mainly China) and the European Union.

  • Inspections of shipments of healthcare and protective equipment 

Laboratory testing

Comprehensive approach to the management of cleaning and disinfection activities to reinforce the implementation of protocols against COVID-19 and methodologies previously defined in your organizations.

  • Bacterial filtration efficiency (BFE). This allows us to determine the filtration efficiency of medical face mask materials. The maximum filtration efficiency that can be determined by this method is 99.9%.

​This certification can be integrated with certification based on ISO 9001, since the production centre visit can be conducted in an integrated manner.


At AENOR, we have been building trust in our society for over 30 years by bringing comprehensive solutions to our customers. AENOR has played a very active role in representing the interests of the Spanish Notified Bodies for various Directives and Regulations in the European field, and is also a Notified Body for 10 EU Directives and Regulations, having issued a vast number of conformity certificates.

AENOR has a large network of auditors specialized in all sectors of activity, who have been trained following rigorous internal rating processes.

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