We all have to deal with it: The New Normal.
In most countries it is mandatory to wear a face mask in public spaces and shops, and yet people look like they are clueless. Walk into any shop and you will see people pretending to be Kilroy or wearing their mask like a chin strap. Maybe there should be a user manual for face masks.
Face mask appear in many forms and colors.
Face mask types
There are three types of face masks, namely:
- “Civilian” face masks
- Medical face masks (or surgical masks)
- Respiratory system protection masks
“Civilian masks”, or masks that we wear every day on the train and in the supermarket, are masks that do not need to be certified.
On many websites you can find information about making face masks yourself, including instructions on how to wear such masks correctly. Some people use a “gator” or a “bandana” for a mask. A CE mark and instructions for use are therefore not required. Easy.
The legal requirements for face masks suddenly become a lot more complicated if certain directives or regulations apply to the face mask. Face masks designed for use in a medical, chemical or polluted environment have much stricter rules.
Medical face masks
Medical face masks are not intended to protect the wearer, but rather to protect the people around the wearer. Studies show that an infected person wearing a mask is up to 80% less likely to spread the virus to others. The mask thus reduces the risk of others becoming contaminated by the air the user exhales. It also reduces the small droplets that land on physical items the person is near.
These surgical mouth-nose masks are a medical device within the rules set up by the FDA in the U.S. and Regulation (EU) 2017/745 and must therefore meet the requirements of these rules and regulations.
There are some differences in the United States and the EU as far as medical masks. The FDA has published lengthy articles about different approved types and their usage. You can find much of that information on the FDA website.
Because medical face masks in the EU fall under (risk) class I of the regulation, no requirements are imposed on the content of the instructions for use:
“Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section”
There is also a harmonised standard for medical face masks: the EN 14683. However, this standard does give requirements for packaging, labeling and product marking, but not for the instructions for use.
Mask as personal protective equipment
The third category of face masks are respiratory protection masks. In the United States these are legally referred to as “Respirator Masks” and are covered by OSHA under 29 CFR 1923.106 and not the FDA like a medical mask.
Respiratory protection masks fall under personal protective equipment within the meaning of Regulation 2016/425 in the EU. In both the US and EU, these types of masks or respirators are intended to filter the air before you inhale it.
The masks fit closer to the face, reducing the chance of unfiltered air flowing past the mask.
Rules in the EU
The EU Regulation requires, in addition to the obligation to include the name and address of the manufacturer, in Annex II the following for the user instructions:
- Instructions for storage, use, cleaning, maintenance, servicing and disinfection.
- Performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE;
- You may be able to use certain accessories with the PPE without affecting performance;
- The classes of protection appropriate to different levels of risk and the corresponding limits of use;
- Where applicable, the month and year or period of obsolescence of the PPE or of certain components of the PPE;
- What type of packaging is suitable to use for transport;
- Meanings of any markings on the PPE;
- The risk against which the PPE is designed to protect must be listed;
- The reference to this Regulation and, where applicable, the references to other Union harmonisation legislation;
- The name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE;
- References to the relevant harmonized standard(s) used;
- The internet address where the EU declaration of conformity can be accessed
There is also a standard for this type of mouth mask: EN 149. The standard does not specify any specific requirements for the instructions.
In the US the rules are quite similar, however there are standards for use and instructions are required to be included. Clearly a lot of people don’t understand why they are wearing a mask, nor how to wear it properly.
There are different requirements for the different types of face masks.
Civil face masks do not fall under CE marking, so instructions are not mandatory. Because these masks automatically fall under the General Product Safety Directive, they still do need to “be safe”. A user manual may help to achieve this.
Instructions for use are not mandatory for medical face masks if they can be used safely without instructions.
When selling face masks on the European market as a non-European manufacturer, make sure you have found yourself an authorised representative within the EU.
For respiratory protection masks, a user manual is mandatory and clear requirements are also set for the content.
Founder of INSTRKTIV and keen to help users become experts in the use of a product, and thus to contribute to a positive user experience. Eager to help organisations to reduce their product liability. Just loves cooking, travel, and music–especially electronic. You can also find him on:
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