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Coronavirus: European standards for medical supplies made freely available to facilitate increase of production

In response to the coronavirus crisis, the Commission has worked with industry and EU countries to maximise the availability of masks, gloves, gowns and other medical supplies. The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have made available a number of European standards for certain medical devices and personal protective equipment.

The 11 standards developed by CEN and potentially three additional ones developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing. Providing free access to the national adoptions of this set of European standards facilitates the work of many companies from both EU and non-EU countries to reconverting their production lines to deliver quickly and ensure that healthcare professionals and patients have access to the equipment they urgently need.

Normally, standards must be purchased and used in line with the intellectual property right rules, as the copyright of the standards lies with the organisations, which have developed the standards. This exceptional decision is a strong European response, based on a sense of social responsibility and solidarity, to address the shortage problem of protective equipment deriving from the Covid-19 epidemics.

Here is the list of CEN standards available for free download:
• EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’
• EN 14683:2019 EN Medical face masks – Requirements and test method
• EN 166:2001 Personal eye-protection – Specifications
• EN 14126:2003 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
• EN 14605:2009 Protective clothing against liquid chemicals – performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
• EN 13795-1:2019 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
• EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment – Part 2: Test methods
• EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (MDD)
• EN 455-2:2015 Medical gloves for single use – Part 2: Requirements and testing for physical properties (MMD)
• EN 455-3:2015 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (MDD)
• EN 455-4:2009 EN Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (MDD)

In addition, upon CEN’s request the following EN ISO standards are made available as read-only:
• EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks
• EN ISO 13688:2013 Protective clothing – General requirements
• EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Source:
For more information and details regarding “European standards”, please visit the website at: https://www.cencenelec.eu/
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