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Since June 1, non-medical mouth masks have been mandatory on public transportation and are recommended to be worn in many places. In several European countries, it is mandatory to wear the mouth masks everywhere you go outside.
Such a non-medical textile mask does not fall under the laws & regulations for personal protective equipment EN 149:2001 +A1:2009 nor under the legislation for medical devices EN 14683:2019+C1:2019 , because those mouth masks are intended for healthcare.
But under what laws & regulations does it fall? And as a consumer or business owner, how do you know if what you are buying is good and satisfactory to protect health?
CAUTION! Textile non-medical mouth masks do not protect you from inhaling small particles of viruses. The mouth masks are meant to protect your environment from the particles you exhale.
Non-medical mouth masks are outside the scope of any specific CE marking legislation.
In principle, all products must meet the requirements set forth in the General Product Safety Directive 2001/95/EC, also known as General Product Safety Directive (GPSD).
This directive applies when specific European regulations for the safety of certain products are lacking. These products do not require CE marking but must meet the general safety requirements for consumer products before they can be sold on the European market.
There are recommendations for non-medical mouth masks from different countries, such as the AFNOR- Spec S76-001 in France, the UNE specification in Spain, the NBN reference document in Belgium and the NEN-SPEC in the Netherlands.
As the use of community masks - also called hygienic masks - becomes part of our daily lives, the European Committee for Standardization (CEN), at the request of the European Union, has published the Workshop Agreement (CWA) guidelines CWA 17553. This freely available document provides a guide of minimum requirements, test methods and usage for reusable or disposable face coverings intended for the general public, excluding those for children under the age of 3.
Non-medical mouth masks are generally made of textile or non-woven textile materials, which means they must meet certain chemical requirements to ensure that the materials do not harm the wearer's health.
The recommendation documents issued by various countries give a good idea of materials, designs, maintenance , required testing, concerns and use of the non-medical mouth masks needed to make this a safe product.
It is recommended that the masks be supplied with clear instructions for use, duration of wearing and maintenance.
Do you need advice on Non-medical mouth masks or Personal Protective Equipment? Précon Quality Services is happy to advise and support you in identifying and meeting your obligations. Feel free to contact us at +31 (0)30 - 65 66 010 or info@precongroup.com.
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