The AND & OR group, in its line of solutions for the sanitary industry, offers to market a machine for the Masks manufactory.

Manufacture of reusable and non-reusable hygienic masks

The Spanish Ministry of Industry, Commerce and Tourism publishes on its website a series of guides for the manufacture of masks and other protective equipment.

In one of these guides, the Ministry responds to a series of frequently asked questions about hygienic, reusable and non-reusable masks related to the requirements that they must meet and the necessary procedures for the mask manufacturing process.

We present below the content of this frequently asked questions guide, recommending in any case, consult the current legislation at all times in official sources.

What should be taken into account in the manufacturing process of hygienic masks

First of all, indicate that hygienic masks have nothing to do with EPI masks (FFP2 and FFP3 masks) or with surgical masks.

With regard to the fight against COVID-19, it can be said that the use of hygienic masks aims to minimize the risks of spreading the virus among the people around us, according to the indications of the Ministry of Health.

According to Ministerial Order SND / 354/2020 of April 19, (Document BOE-A-2020-4525) indicates in its second point:

“Area of ​​application…

Point b) … without covering the condition of medicine or health product, hygienic masks are considered essential for the protection of the health of the population, minimizing the risk of contagion of COVID-19. In particular:

  1. Non-reusable hygienic masks (single use) such as reusable hygienic masks, considered as the face piece that covers the mouth, nose and chin and provided with a head harness and that must comply with the technical specifications UNE 0064-1: 2020, UNE 0064-2: 2020, UNE 0065: 2020 as well as any other standard that guarantees compliance with the criteria established in the aforementioned specifications.

The manufacture of masks requires minimum requirements that they must meet:

When manufacturing hygienic masks, whether reusable or not, in addition to complying with the requirements established in said ministerial order, they must comply with other legislation such as:

  • Legislative R.D 1/2007 of November 16 in which the revised text of the law for the Defense of consumers and users and other complementary laws is approved. Consolidated document BOE-A-2007-20555
  • R.D. 1468/1988 of December 2, which approves the regulation on labeling, presentation and advertising of industrial products intended for direct sale to consumers and users. Consolidated document BOE-A-1988-28089
  • In the case of a textile product, other legislation that must be complied with refers to Regulation (EU) 10R.D. 1801/2003 of 12/26 on the general safety of products, on the duty not to injure or endanger the health and physical integrity of people. Consolidated document BOE-A-2004-511
  • 07/2011 of the European Parliament and of the Council of 11/27/2011 on the names of the fibers and on the labeling and marking of the fiber composition. The R.D. 1801/2003 of 12/26 on the general safety of products. 32011R1007 – EN – EUR-Lex

UNE specifications accepted to manufacture hygienic masks

Single use masks (not reusable)

  • Non-reusable hygienic mask

UNE 0064-1
Requirements for materials, design, preparation, marking and use.

Part 1: For use in adults.
This document provides the minimum requirements that hygienic masks for adults must meet, especially with regard to the materials used for their manufacture, manufacture, marking and use, and which is not applicable to surgical masks, which are governed by another rule.
Non-reusable hygienic masks

UNE 0064-2
Requirements for materials, design, preparation, marking and use.

Part 2: For use in children.
In the same way as the previous standard, this one provides the minimum requirements that hygienic masks for children must meet.

Reusable masks

  • Reusable hygienic masks for adults and children.

Specifications UNE 0065
Requirements for materials, design, preparation, marking and use.

Minimum requirements that must be met.

Is it mandatory to comply with the UNE specifications in the manufacture of hygienic masks?

As specified in the Ministerial Order, when manufacturing this type of mask, the manufacturer may choose to comply with the UNE specifications or, failing that, comply with other equivalents, as long as it is guaranteed that the criteria of acceptance.

Procedures necessary to manufacture and market hygienic masks

For these products, there is no type of approval or CE marking, so no type of authorization from the Administration is necessary.

The manufacturer is responsible for ensuring that the product complies with all applicable requirements, testing, labeling, etc. .. and once these checks have been made, it can always be manufactured and marketed under its responsibility without prior authorization.

For their part, the surveillance authorities, upon detecting doubtful products, may request the information and documentation they consider and take the appropriate measures.

Differences between reusable and non-reusable masks

  • Non-reusable masks are for single use only and must be disposed of after use and use for more than 4 hours is not recommended.
  • Reusable masks are designed so that they can be washed and used several times, so they require that the materials for the manufacture of these masks are washable.

What is the maximum number of washes?

According to UNE 0065: 2020 it is indicated that reusable masks must withstand at least 5 washes and dried without losing performance, so we can say that the maximum number of washes must be at least 5, unless the manufacturer guarantees a higher number.

Washing methods

The manufacturer must specify the permitted washing methods so that the material used does not lose its properties.

You can check the washing methods allowed in this link on the website of the Ministry of Health:

Cleaning and disinfection of reusable hygienic masks

All the information provided in this article has been extracted from the Guides published by the Ministry of Industry, Commerce and Tourism, for the manufacture of masks and protective clothing:

Guides for the manufacture of masks and protective clothing

Regarding the materials for the manufacture of masks, at AND & OR we offer our clients the raw material for their production:

Spunbond for the outer layer and Meltblown masks BFE 95 and BFE 99 for the middle layer.