Certifications

 

CE Marking

CE marking is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).[1] (It is not a quality indicator or a certification mark.[2]) The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense like the FCC Declaration of Conformity used for selling certain electronic devices in the United States.

The CE marking is the manufacturer's declaration that the product meets EU standards for health, safety, and environmental protection.[3]

The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.

"CE" is sometimes indicated as an abbreviation of "Conformité Européenne" (French for "European Conformity"),[4] but is not defined as such in the relevant legislation. The CE mark indicates that the product may be sold freely in any part of the European Economic Area, irrespective of its country of origin.

 

Food and Drug Administration

In general, masks are used by the general public and health care personnel to prevent the spread of infection or illness.

This page is for people and organizations who are new to working with the FDA. To help expand the availability of face masks and surgical masks, the FDA is providing regulatory flexibility, as described in our policy for face masks and surgical masks that is in effect during the COVID-19 pandemic.

If you are interested in manufacturing these products, we urge you to review:

You may send any specific questions to CDRH-COVID19-SurgicalMasks@fda.hhs.gov.

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

EN 14683:2005

This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff.

This standard is intended to help facilitate the choice of surgical face masks in the European Market by standardizing the information and performance data required for the masks.
There are three test methods used to classify surgical masks:

1. Bacterial Filtration Efficiency in vitro (BFE) (ASTM F2101-07)
This test is used to determine the amount of infective agent that is retained by the surgical facemask, which is directly related to the amount of bacteria released through the mask into the air of the surgical theatre.
Classification:
BFE => 95% TYPE I
BFE => 98% TYPE II

2. Breathing Resistance (Delta P)

This test is used to determine the resistance airflow of the facemask. Classification:
TYPE I & II (non splash resistant) = < 29.4 Pa/cm2
TYPE IR & IIR (splash resistant) = < 49.0 Pa/cm2

3. Splash Resistance (ASTM F1862-07)
This test is used to determine the resistance penetration of potentially contaminated fluid splashes.
Classification:
TYPE I & TYPE II not applicable
TYPE IR & TYPE IIR >120 mmHg
120 mmHg is a minimum value. It corresponds to the average systolic arterial blood pressure, and intends to protect against ruptures in small arteries causing small sprays of blood. Some products off protection even in excess of the 120 mmHg.

Minimum Performance Requirements According to the New Facemask Standard EN14683

EU Standard Class

Type I Type IR Type II Type IIR

Bacterial Filtration Efficiency

95% 95% 98% 98%

Breathing Resistance (Pa/cm2)

< 29.4 < 49.0 < 29.4 < 49.0

Splash Resistance (mmHg)

NA > 120 NA > 120

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