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The UNE Specifications has been published to facilitate the manufacture of protective masks

09/09/2021

On 9 September 2021, the new versions of the UNE Specifications for protective masks were published: UNE 0064-1 and UNE 0064-2 (non-reusable) and UNE 0065 (reusable). As with the previous versions, they are available free of charge on this website.

Among the main changes compared with the previous versions published in April 2020 is the alignment of the new UNE Specifications with Order CSM/115/2021 establishing the information and marketing requirements of protective masks with regard to marking and instructions for use.

In addition, the new versions alter the manufacturing chapter of Specifications 0064-1 and 0064-2, to allow manufacturers to create protective masks with other patterns and other methods of manufacture.

Similarly, the quality limit acceptable in trials has been changed and details clarified in terms of the number of samples to be taken and what to do if a sample does not meet the acceptance criteria in the first sampling, with the aim of making the requirements clearer and easier to understand and apply.

As a whole, the modifications made do not constitute radical changes in the documents, or any modification in relation to the minimum requirements for the effectiveness and use of the masks (minimum required filtration, breathability, etc.). The new version maintains the focus of the 2020 specifications and includes clarifications and improvements resulting from the experience gained over the last year, which will help manufacturers to better understand each part of the text, and will facilitate compliance with Order CSM/115/2021.

The origin of these three specifications dates back to last year. The Spanish Association for Standardization, UNE, published the first version of Specification 0065 in April 2020, which establishes the requirements that reusable masks for children and adults must comply with in terms of the materials used for their design, manufacture, marking and use. This document will facilitate the manufacture of reusable masks, both industrial and artisanal, in the required volume, offering citizens a protective barrier against the COVID-19 pandemic. UNE made the document freely available to the general public. Download the the new version of UNE Specification 0065.

This UNE Specification provides manufacturers with clear requirements for the manufacture of reusable masks. All of this, with the guarantee that, if manufactured in accordance with the provisions of the Specification, a mask will be obtained with an acceptable level of bacterial filtration efficiency and breathing resistance. The possibility to reuse the masks considerably increases their useful life and therefore the availability of the product in the necessary volume.

This Specification is flexible and accommodates other materials and designs, different from those indicated, although these modifications must be tested with respect to the tests detailed in the Specification in order to mark the final product with respect to the document. This allows the range of materials and designs that can be used to be expanded considerably, which is of great interest to national industry. 

The Specification provides the end user with instructions for wearing, use, removal, storage and washing, which are fundamental to guaranteeing the protection for which they have been designed, both for first usage and for subsequent uses.

This Specification is in addition to UNE 0064-1 and UNE 0064-2, which have now been updated, that establish the requirements for single use protective masks for adults and children, respectively.

Both UNE, the Ministry of Industry, Trade and Tourism and the Ministry of Consumer Affairs have drawn up guides with frequently asked questions (FAQ) that address numerous issues regarding hygiene masks in accordance with UNE specifications and other types of protective masks. These are aimed at both manufacturers and consumers: from marking/labelling, to where they can be purchased, including processing for manufacturing and sale, what type of mask we need, or how to use them correctly. On this website we provide you with a series of documents with frequently-asked questions about the types of masks that exist on the market and the characteristics of each one.

This set of products, each with specific uses and features, aims to provide citizens with a barrier that allows them to keep protected and to continue with their daily lives. This is a fundamental measure, together with the rest of the social distancing measures, to face the current scenario.

The drafting of the three UNE Specifications was participated in by the Ministry of Health; The Ministry of Industry, Trade and Tourism; The Ministry of Consumer Affairs; Ministry of Labour and Social Economy; AEMPS; INSST; AIMPLAS; CIE; FENIN; AITEX; ASEPAL; IBV; COIIM; EURECAT; LEITAT; TEXFOR; FEDECON; INDITEX; ITENE and AENOR INTERNACIONAL, SAU.