In the context of the COVID-19 pandemic, CEN, the European Committee for Standardization, agreed, in collaboration with all their Members and after the urgent request from the European Commission, to make temporarily available for free a new set of European standards (ENs). The seven standards cover respiratory equipment and patient critical care ventilators.

The CEN and CENELEC community has consistently supported the European joint efforts against the COVID-19 pandemic since its outset. Notably, it made available free-of-charge 14 European Standards related to medical and protective equipment since March 2020, as well as a CEN Workshop Agreement on ‘Community face coverings - Guide to minimum requirements, methods of testing and use’ (CWA 17553:2020) developed in June 2020.

Providing free access to the national adoptions of this set of European standards facilitates the work of the many companies within the European Economic Area which in the past months have reconverted their production lines to deliver tangible results quickly and ensure that healthcare professionals and patients have access to the equipment they urgently need.

The seven standards made available, developed by CEN jointly with ISO, the International Standardization Organization, cover a variety of key respiratory equipment to counter the effects and spread of COVID-19. Together with the ones previously made available, they are the fruit of a collective European and international effort, and were developed by different Technical Bodies, taking into account the contributions of hundreds of experts and stakeholders in the medical field.

Elena Santiago Cid, CEN and CENELEC’s Director General, commented: “This exceptional decision is an example of the continuous efforts and substantial contribution the CEN and CENELEC members are making to support industry, SMEs, consumers and governments in combatting the current pandemic by taking further measures at national level. Our flexibility in adapting our business models and make available free-of-charge a series of European standards for personal protective equipment, medical and respiratory devices used in the context of the COVID-19 pandemic is the evidence of our commitment to provide sustainable standardization solutions for the current European recovery.”

The standards are available for free download from the websites of CEN national members.

The full list of standards follows:

• EN ISO 5356-1:2015 ‘Anaesthetic and respiratory equipment - Conical connectors – Part 1: Cones and sockets (ISO 5356-1:2015)’
• EN ISO 10651-4:2009 ‘Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)’
• EN ISO 17510:2020 ‘Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)’
• EN ISO 18082:2014 ‘Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014)’
  and Amendment EN ISO 18082:2014/A1:2017 (ISO 18082:2014/Amd 1:2017)
• EN ISO 80601-2-12:2020 ‘Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)’
• EN ISO 80601-2-79:2019 ‘Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)’
• EN ISO 80601-2-80:2019 ‘Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)’

CEN

CEN (European Committee for Standardization) is recognised by the European Union (EU) and the European Free Trade Association (EFTA) as one of the European Standardization Organizations responsible for developing standards at European level. These standards set out specifications and procedures in relation to a wide range of materials, processes, products and services.

The members of CEN are the National Standardization Bodies of 34 European countries. European Standards (ENs) and other standardization deliverables adopted by CEN are accepted and recognised in all of these countries.

European Standards (ENs) contribute to enhancing safety, improving quality, facilitating cross-border trade and strengthening the European Single Market. They are developed through a process of collaboration among experts nominated by business and industry, research institutes, consumer and environmental organizations, trade unions and other stakeholders. CEN works to promote the international alignment of standards in the framework of technical cooperation agreements with ISO (International Organization for Standardization).

CEN website: www.cen.eu

CEN-CENELEC website: www.cencenelec.eu

Media contact:

Giovanni Collot

Project Manager Governance & Partnerships

CEN-CENELEC Management Centre

T: +32 474 98 21 17                                                                                           

Email: gcollot@cencenelec.eu
Twitter: @Standards4EU