BSI makes European standards for medical devices and PPE available

25 March 2020

In response to the European Commission’s request and in association with CEN, the European Committee for Standardization, and CENELEC, the European Committee for Electrotechnical Standardization, BSI has made a series of European Standards (ENs) for medical devices and personal protective equipment (PPE) used in the context of COVID-19 available on its website. This is to help support the efforts to fight the pandemic. 

The standards, which cover face masks, medical gloves and protective clothing are listed below and can be accessed here: 

  • 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)

The following can also be accessed as read-only:

  • 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