Reusable Face Coverings / Barrier Masks Standards/ Specifications

Reusable Face Coverings / Barrier Masks Standards

(SWIFT 19 Specification/ CEN Workshop Agreement)

In Ireland, there is a specification for Barrier Masks known as the SWIFT 19 Specification which has been developed by National Standards Authority of Ireland at the request of the CCPC. CEN, the European Committee for Standardization also developed a new CEN Workshop Agreement on face coverings.

The SWIFT 19 Specification and/or the CEN Workshop Agreement can be used by a producer of Barrier Masks to enable them to demonstrate conformity (pursuant to Regulation 5 (3) (b) of S.I. 199 of 2004) with the general safety requirements of S.I. 199 of 2004.

The SWIFT 19 Specification specifies the minimum requirements for the design, manufacture, performance, packaging, marking and information for use, for Barrier Masks intended for single use or reusable use for consumers to reduce the risk of general transmission of a viral infection. The SWIFT 19 Specification includes testing methods for performance requirements specified for the Barrier Masks.   At this time, there are no harmonized European standard for Barrier Masks for general consumer use, unlike masks for personal protective equipment or medical devices.

Barrier Masks must not be sold as either personal protective equipment or medical devices. Products which do not comply with the requirements for personal protective equipment or medical devices must not give consumers a false impression that they are personal protective equipment or medical device. Therefore, product information for Barrier Masks must not contain references to personal protection equipment standards or classifications such as FFP2, EN 149, KN95, or N95. Barrier Masks must not contain claims that they protect, or are intended to protect, the wearer from viruses such as COVID-19. Such claims would be considered criminal offences under consumer protection and product safety law.

In line with the SWIFT 19 Specification:

  1. Markings: Barrier Masks should be clearly and durably marked with the information below on the smallest marketable package available:
    1. The Barrier Mask should include the wording “Barrier Mask”.
    2. The name and address of the producer.
    3. Indication of whether product is for single use or reusable.
    4. Any warnings;
    5. Any other requirements in the SWIFT 19 Specification.
  2. Instructions for Use: Barrier Masks should be supplied with an instruction/user guide which shall be in English and include necessary information on:
    1. any warnings or information;
    2. cleaning of Barrier Mask;
    3. safe use of the Barrier Mask;
    4. how to fit, use, put on and remove the Barrier Mask.
  3. Warnings and Information: The Barrier Masks should contain the following warnings on both the package and the product information:
    1. Warning: This Barrier Mask is not intended to protect the consumer against viral infection. Used in conjunction with relevant public health advice, a Barrier Mask may help prevent the spread of viral infection to others.
    2. Warning or Warning Symbol: Indicating that this Barrier Mask is not suitable for children under the age of three.
    3. Warning: Children should be supervised at all times.
    4. This is not personal protective equipment or a medical device under EU law.
  4. CE Marking: Barrier Masks, as GPSD products, must not bear the CE Marking.
  5. Testing: The producer is required to conduct verification and validation tests within its facility or in collaboration with a test laboratory that has the appropriate means of testing before placing any Barrier Mask on the market.

This is not an exhaustive list of the specifications in the SWIFT 19 Specification and all producers should consult the full text of the SWIFT 19 Specification.

 

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