CEN, the European Committee for Standardization, and CENELEC, the European Committee for Electrotechnical Standardization, in collaboration with all their Members and after the urgent request from the European Commission, have taken the exceptional decision 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 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.
List of the standards:
– 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 EN Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (MDD)
Jointly CEN-ISO standards:
– 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
Additional information: PRESS RELEASE, Brussels – 20 MARCH 2020
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