Simplified procedure for Corona SARS-Cov-2 virus pandemic respiratory masks (CPA)
also to purchase respirators without CE marking, provided that it is ensured that the products are only available to healthcare professionals and only for the duration of the current health threat and that they are not placed in the normal distribution channels and made available to other users,
authorize the making available of respirators on the Union market for a limited period of time, even though the relevant conformity assessment procedures for these products are not fully in line with the harmonized standards. The prerequisite for this is that the respirators ensure an adequate level of health and safety.
DEKRA Testing and Certification GmbH (DEKRA) and the Institute for Occupational Safety and Health (IFA) of the German Social Accident Insurance have therefore drawn up test principles in which they define the minimum requirements for coronavirus pandemic respirators (CPA) in order to be able to check in a short time whether the respective products can be used in accordance with the exceptions set out by the Commission. The shortened procedure is only to be carried out for respirators whose adequate level of health and safety cannot be demonstrated by other means (Declaration of Conformity/CE marking, compliance with US, Canadian, Australian, Japanese or Chinese regulations).
DEKRA and IFA adhere to this testing principle during the inspection and prepare a test report and an assessment letter. The CPAs are not certified in this procedure. The confirmation of successful completion of the abbreviated inspection procedure can be used as a basis for determining whether an exception has been presented by the Commission.
The assessment letter is then sent to the Central Office of the Federal States for Safety Engineering (ZLS). The ZLS then informs the market surveillance authorities that, as an exception, the tested masks do not have to be withdrawn from the market until the end of the pandemic, even if they have not undergone an EU conformity assessment procedure.
In addition, the European standardization organizations CEN and CENELEC, with the agreement of all their members - including DIN (German Institute for Standardization) - and in consultation with the European Commission, have decided to make a number of European standards for medical devices and personal protective equipment available free of charge to support the fight against the Covid-19 pandemic. By making the standards for protective masks and gloves as well as other personal protective equipment (PPE) products available free of charge, the aim is to help companies that want to convert their product lines in order to produce the equipment that is currently so urgently needed at short notice.