FREQUENTLY ASKED QUESTIONS ABOUT REUSABLE HYGIENIC MASKS•
Posted on Thursday, May 21, 2020 at 10:5
Every day there are new communications from the Ministry of Industry, Commerce and Tourism about reusable and non-reusable hygienic masks in the context of COVID-19, due to the offer that can be found online or in non-specialized stores and with the aim of of informing the consumer about what they should buy and how.
We have doubts and you ask me questions about reusable masks, which we are going to summarize as published by the Ministry, but the first warning that I would like to highlight is the following paragraph;
What is the minimum that this type of mask must meet?
- In case of being a textile product, Regulation (EU) No. 1007/2011 of the European Parliament and of the Council, of September 27, 2011, regarding the names of textile fibers and the labeling and marking of composition in fibers of textile products, as well as Royal Decree 1801/2003, of December 26, on product safety.
What UNE specifications are accepted to manufacture these masks?
- Reusable masks: UNE0065, Reusable hygienic masks for adults and children. Requirements for materials, design, manufacturing, marking and use.
Is it mandatory to comply with the aforementioned UNE 0065:2020 specifications to manufacture these masks? Can other different specifications be used?
- Other specifications may be chosen as long as compliance with the acceptance criteria is guaranteed.
What instructions and labeling should these masks have?
- If the mask complies with all the indicated UNE specifications, it must additionally carry all the information requested in said specifications. These UNE specifications include very detailed model instructions, with the information that the consumer must know about the use of the mask. The manufacturer must provide this information to the consumer
- The market surveillance authorities, if they detect doubtful or non-compliant products on the market, may request all the information and documentation they deem necessary, and take appropriate measures.
What are the acceptance criteria?
Which laboratories can test these materials?
The laboratory that performs the tests must be a laboratory that is qualified to test products with respect to said standard (UNE-EN 1463:2019+AC:2019) Harmonized standard with respect to Directive 93/42/CEE on medical devices.
How are reusable masks different from non-reusable ones?
Non-reusable masks are for single use. Reusable ones are designed to be washed (or sanitized), so they can be used multiple times. This implies that reusable masks must be made of materials that are washable (or that can be sanitized)
What is the maximum number of washes?
According to the UNE 0065:2020 regulation, it is indicated that the mask must be able to withstand 5 washing and drying cycles while maintaining its performance (that is, the maximum number of washings must be at least 5, although the manufacturer can opt for ensure more washes). After the maximum number of washes indicated by the manufacturer, the manufacturer must be able to guarantee that the reusable hygienic mask meets the specified criteria.
What washing methods can be used?
They will depend on the material used. The manufacturer must indicate which method to use among the admitted methods so that the material does not lose performance.
The maximum number of washes and the method must be justified by the manufacturer.These data must correspond to the way in which the product has been tested, testing before and after the maximum number of washing cycles
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