Following European Accreditation Communication (updated 05 May 2020), the EU guidelines state that masks and respiratory protective devices, such as respiratory half-masks, shall be tested in order to ensure that the requirements are met. The requirements are set out in the following European Standards:
▪ EN 14683:2019 Medical face masks - Requirements and test methods This standard specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. This European Standard is not applicable to masks intended exclusively for the personal protection of staff.
▪ EN 149:2001 + A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking This European Standard specifies minimum requirements for filtering half masks as respiratory protective devices to protect against particles except for escape purposes. Laboratory and practical performance tests are included for the assessment of compliance with the requirements.
However, as also covered by our blog post on general PPE (personal protective equipment) regulations............................................
Some types of products that appear to be similar to PPE may actually be regulated as medical equipment if their main purpose is to protect others from the user (like a surgical face mask). A medical gown is a medical device if it is to protect the patient from the doctor. If it is to protect the doctor from the patient, it is PPE.
The essential health and safety requirements (listed in Annex II of EU Regulation 2016/425) apply to all PPE within the scope of that Regulation. Under article 19, all PPE within scope must undergo a conformity assessment procedure in accordance with its risk categorisation (specified in Annex I) to demonstrate compliance with the essential requirements.
Under the easements in Recommendation 2020/403, PPE specifically necessary for protection in the context of the COVID-19 outbreak must continue to meet the essential safety requirements. However, for a limited time, provided it meets the essential safety requirements, and provided conformity assessment procedures have been started via a Notified Body, PPE can be placed on the market, even if the conformity assessment, including affixing of CE marking procedures, has not been completed.