European Union bureaucrats have stepped up to the plate and to provide a small but significant contribution to combat Covid-19. The combat against the spread of the Corona-virus is challenging due the great shortage of face masks and other personal protective equipment for medical staff. In an effort to help increase the availability of masks, gowns and gloves the European regulators and standardizers try to remove any obstacle to increase production by making the European harmonised standards available to producers free of charge.
Upon the urgent request of the Commission, the European standards bodies CEN and CENELEC, in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety.
The agreement has immediate effect. The 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing.
How the free access to these standards helps increasing production
Providing free access to the national adoptions of these European standards helps both EU and third-country companies which are reconverting their production lines to manufacture quickly these critical items for preventing the coronavirus pandemic. The use of the standards will enable companies that use them to access the market for such fundamental medical and protection equipment quicker and to provide those in need with such medical equipment.
Normally, standards must be purchased and used in line with the intellectual property right rules. The copyright of the standards lies with the organisations, which have developed the standards. The derogation from this business model is a strong European response to address the shortage problem of protective equipment deriving from the Covid-19 epidemics.
The standards are available for free download from the websites of CEN national members.
List of available standards:
- 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, possibly:
- 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