The solution

Access to the 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO made available cover common filtering masks, medical gloves and protective clothing.

How can it help to manage the COVID-19 pandemic?

In response to the coronavirus outbreak, CEN, and CENELEC agreed, in collaboration with all their Members and after the urgent request from the European Commission, to make freely available a series of European standards (ENs) for medical devices and personal protective equipment used in the context of the COVID-19 pandemic.

The list of the standards follows:
• EN 149:2001 + A1:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’)
• EN 14683:2019 Medical face masks – Requirements and test methods
• EN 166:2001 Personal eye-protection – Specifications
• EN 14126:2003 + AC 2004 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
• EN 14605:2009 + A1:2009 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 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (MDD)

In addition, possibly:
• EN ISO 374-5:2016 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 + AC 2010 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

Target groups

  • EU relevant industries
  • The authorities