Mask CE Certification

The European Union classifies masks into two categories based on their usage: personal protective masks and medical masks.

Personal Protective Masks:

Personal protective masks are not considered medical devices but must comply with the EU Personal Protective Equipment Regulation EU2016/425 (PPE). CE certification is required and issued by a Notified Body, with the corresponding standard being EN149.

Medical Masks:

- Medical masks: These comply with the standard 93/42/EEC (MDD) or the EU Medical Device Regulation EU-2017/745 (MDR) and bear the CE mark. The corresponding standard is EN14683.

- Sterile medical masks: Must undergo CE certification by an authorized body.

- Non-sterile medical masks: Enterprises need to issue a CE self-declaration of conformity.

Mask Testing Items (EU Regulations):

EN149:2001+A1:2009 Respiratory Protective Equipment

Self-priming filter-type respirators for particle protection are tested for the following:

- Appearance inspection

- NaCl filtration efficiency

- Oil filtration efficiency

- Dead space

- Field of vision

- Head straps

- Connections and connecting components

- Flammability

EN14683:2005, EN14683:2019 Medical Surgical Masks

Key testing items include:

- Material and structure

- Bacterial filtration efficiency

- Differential pressure

- Synthetic blood penetration resistance

- Microbial cleanliness

- Biocompatibility

JJR Laboratory in China provides testing for CE certification of masks as well as FDA-specified requirements, helping enterprises save up to 30% on testing costs. Feel free to inquire for more information.