Homemade masks do not protect you from the coronavirus – respiratory protective equipment must be safe and provide sufficient protection
Joint press release: The Finnish Safety and Chemicals Agency (Tukes), the Finnish Institute of Occupational Health (TTL) and the Finnish Medicines Agency Fimea. The authorities wish to remind consumers that homemade masks do not protect the user from the coronavirus. However, if the user of the mask is infected with the virus, the mask may protect others. At worst, homemade protective equipment may even spread the virus, if proper hygiene is not used. If a homemade mask is used incorrectly, it increases the amount of impurities in front of the airways. A mask is not a respiratory protective device. The sale and import of official respiratory protective equipment and surgical masks is carefully controlled.
The use of different kinds of homemade masks and other kinds of improvised equipment has become more common. Nevertheless, the best way to protect yourself from the coronavirus is to stay at home, keep a distance of at least 1–2 metres from other people, and wash your hands with soap and water or clean them with an alcohol-based hand sanitiser.
The Finnish Institute of Occupational Health (TTL), the Finnish Safety and Chemicals Agency (Tukes), the Finnish Medicines Agency Fimea and the Ministry of Social Affairs and Health provide instructions concerning respiratory protective equipment and the related legislation.
According to THL, surgical masks are recommended for protection against droplets for workers who care for patients with a respiratory infection. The use of respiratory protective equipment (FFP2 or FFP3) is recommended when carrying out procedures that produce aerosols during treatment in intensive care, for example. Patients with a respiratory infection can be instructed to use a surgical mask in waiting rooms or during transport, for instance.
If you are making masks for yourself or friends and family
- Remember that a homemade mask is not personal protective equipment. A mask does not protect the user from coronavirus.
- A dirty mask can spread the virus.
- A mask may protect other people from the droplets spreading from the airways of the person wearing the mask. It may be good if asymptomatic carriers of the disease wear a mask in public transport or at shops etc., but there is no scientific proof.
- Comply with the restrictions on movement even if you wear a mask. Stay at home and only do the shopping when necessary. If you are quarantined, do not leave your home. Keep a distance of 1–2 metres from other people and wash your hands with soap.
- Put a clean mask on with clean hands.
- Keep the mask clean: do not touch the mask while wearing it
- When you take the mask off, only touch the straps and put the used mask directly into a plastic bag or the washing machine. Wash your hands and wash the mask after each use. The mask must be washed in 90 degrees Celsius.
- Remember that touching the mask increases the amount of impurities in front of your airways, for instance. Using a mask incorrectly does more harm than good.
- When wearing a mask, you cannot take it off or lower it to your neck, and you cannot eat or drink.
- When making the mask, use several layers of thin fabric. Bedsheets are a suitable material, for example. Make sure that you can breathe easily while wearing the mask.
- Note that if the mask gets wet, it allows microbes to penetrate more easily than a dry mask.
- Do not pressure anyone to wear a mask. Symptoms of cardiovascular diseases, asthma or chronic obstructive pulmonary disease (COPD) may prevent people from using a face mask. A dirty mask may be a health hazard.
If you sew as a hobby and make masks for sale
- Emphasise that your products are not personal protective equipment or surgical masks: the masks you make do not protect the user from the coronavirus, among other things.
- Make sure that your masks do not cause a health hazard to the users.
- Instruct the buyer not to touch the mask during use. Touching the mask increases the amount of impurities in front of the airways, which may harm the user.
- Use a material that can be washed in the washing machine at 90 °C.
- Note that if the mask is not breathable enough, wearing it may cause a health hazard, especially if the user suffers from cardiovascular diseases, asthma symptoms or chronic obstructive pulmonary disease (COPD).
- The name of your product must not refer to respiratory protective equipment or surgical masks in any way. A name that refers to respiratory protective equipment can only be used if the products fulfil the requirements for respiratory protective equipment. Surgical masks must fulfil the requirements for medical devices.
- Your marketing material must not provide conflicting information on the product’s purpose of use. If the mask does not fulfil the requirements on personal protective equipment, its marketing may not use words, expressions or images that would give consumers the impression that the product protects it user or acts as protective equipment.
- Your marketing material must not provide conflicting information claiming a handmade mask to be a surgical mask.
If you want to manufacture surgical masks for professional use
- The products must fulfil the requirements on medical devices (product class I).
- The products must have a CE marking as well as the name and address of the manufacturer.
- The products can be placed on the market without an assessment by a notified body, i.e. the manufacturer that placed the products on the market is solely responsible for them.
- The documentation required to demonstrate the conformity of the products must be available to the supervisory authority, that is, Fimea.
- Register as a domestic manufacturer with Fimea and provide a copy of the declaration of conformity.
- More detailed requirements and test methods can be found in the standard EN 14863.
If you want to manufacture respiratory protective equipment (e.g. FFP2/FFP3 respirators)
- The PPE (personal protective equipment) must fulfil the requirements of the Personal Protective Equipment Regulation (EU) 2016/425.
- Have the EU type examination of the PPE conducted (by a notified body).
- Draw up an EU Declaration of Conformity for the product in Finnish and in Swedish.
- Respiratory protective equipment must have the identifier of the manufacturer and the PPE as well as a CE marking, followed by the identifying number of the notified body that monitors the quality of the PPE. A CE marking can be attached to PPE when the product has been type approved and the EU Declaration of Conformity has been drawn up.
- Include operating instructions in Finnish and in Swedish with the respiratory protective device. Operating instructions are important so that users can put the PPE on correctly and know from what it protects them.
- Also familiarise yourself with the standards of Finnish Standards Association SFS related to respiratory protective equipment, such as EN 149, before starting production.
- See illustrative images of respiratory protective equipment on the website of the Finnish Institute of Occupational Health (TTL).
Respiratory protective equipment for consumers (e.g. FFP2/FFP3)
- The PPE must fulfil all of the abovementioned requirements of the Personal Protective Equipment Regulation in all respects.
- The manufacturer must state that the respiratory protective device is intended to protect consumers.
Respiratory protective equipment for professional use (e.g. FFP2/FFP3)
- The PPE must fulfil the requirements of the Personal Protective Equipment Regulation that apply to it in all respects.
- The manufacturer must state that the respiratory protective device is intended for use at work. If the purpose of use is not described, the PPE is considered to be intended for professional use.
Respiratory protective equipment intended for professional use that protects the user from the coronavirus
Protection level corresponds to the FFP2 level; during the COVID-19 pandemic, FFP protective equipment cannot be tested
Intended only for protection against coronavirus in professional use
The test report must demonstrate that the performance reaches the level specified in the essential health and safety requirements listed in Annex II of the Personal Protective Equipment Regulation.
The EU type examination certificate and the EU Declaration of Conformity have not been drawn up
The PPE does not have a CE marking
The operating instructions in Finnish, Swedish or English provided with the PPE do no need to be as extensive as usual
Reporting less information than usual in the labelling of the PPE is allowed.
Instructions on the issue can be found in the guidelines of the Ministry of Social Affairs and Health (in Finnish).
If you intend to place respiratory protective equipment or surgical masks on the market, the authorities can provide you with more information on the legislation related to the products and the preconditions for placing them on the market.
|Authority||Product||Further information on the requirements on the product||Further information/other things to note|
|Finnish Safety and Chemicals Agency (Tukes)||respiratory protective equipment intended for consumer use||Personal Protective Equipment Regulation (EU) 2016/425||Press release: Huomioi nämä, kun myyt hengityksensuojaimia (in Finnish)|
|Finnish Safety and Chemicals Agency (Tukes)||civil masks masks for consumer use||Consumer Safety Act 920/2011 and the Government Decree on information to be supplied in respect of consumer products and services 613/2004||
General consumer products cannot have a CE marking.
If a product does not fulfil the requirements for PPE, consumers must not be given the false impression that the product in question would constitute PPE. If civil masks or corresponding products are marketed to consumers as respiratory protective equipment, they must fulfil the requirements on PPE.
|Department for Work and Gender Equality (TTO) of the Ministry of Social Affairs and Health||respiratory protective equipment intended for professional use||Personal Protective Equipment Regulation (EU) 2016/425||EU type examination is required for these products. The requirements were lowered on 31 March 2020. See the guidelines of the Ministry of Social Affairs and Health.|
|Finnish Medicines Agency Fimea||surgical masks for health care personnel||Regulation (EU) 2017/745 on medical devices or Directive 93/42/EEC||The products must have a CE marking. The product information must include the name and address of the responsible manufacturer. If the manufacturer is outside Europe, the name and address of the authorised representative in Europe must also be included.|
|Finnish Institute of Occupational Health (TTL)||expert support concerning respiratory protective equipment and surgical masks intended for both professional and consumer use||The Finnish Institute of Occupational Health (TTL) is an expert and researcher of respiratory protective equipment, not an authority. Earlier, the Finnish Institute of Occupational Health (TTL) also carried out testing and certification of PPEs, but in the autumn of 2019, the testing and certification activities were sold to SGS Fimko.|
respiratory protective equipment sold to consumers:
Senior Officer Asta Koivisto, Tukes. tel. +358 29 5052 187.
e-mail address format: firstname.lastname(at)tukes.fi
respiratory protective equipment intended for professional use:
Ministerial Adviser Pirje Lankinen, Ministry of Social Affairs and Health, tel. +358 295 163 488
Senior Officer Tapani Vänni, Ministry of Social Affairs and Health, tel. +358 295 163 219
e-mail address format: firstname.lastname(at)stm.fi
surgical masks for health care personnel:
Inspector Tuomo Aarnikka, Fimea. tel. +358 29 5223278, Fimea
e-mail address format: firstname.lastname(at)fimea.fi.
Information on surgical masks and respiratory protective equipment:
Senior Specialist Erja Mäkelä, Finnish Institute of Occupational Health (TTL), tel. +358 30 474 2595, erja.makela(at)ttl.fi, Finnish Institute of Occupational Health (TTL)
Tietoa itse tehdyistä suojaimista, suu-nenäsuojuksista ja hengityksensuojaimista (Finnish Institute of Occupational Health (TTL))
Press release by Fimea: Kevyet nenä-suusuojaimet eivät ole riittäviä estämään virustartuntoja (18 March 2020)
Tukes bulletin: Huomioi nämä kun myyt hengityksensuojaimia (13 March 2020)
Tukes bulletin: Uusi vientilupavaatimus henkilönsuojaimille koronavairuksen takia (20 March 2020)