Technical standards for medical equipment available free of charge

Corona crisis: Technical standards for medical equipment now available free of charge

European standardisation organisations CEN and CENELEC support new product lines

In order to ensure that medical equipment (such as in particular respiratory protective devices or filter masks, medical gloves and protective clothing) can be produced and made available as quickly as possible within the EU, eleven relevant EN standards for the manufacture of PPE on the one hand and medical devices on the other are now available free of charge throughout the EU. The initiative originates from the two European standards organisations CEN and CENELEC, which in turn have responded to a request from the European Commission: The common goal of all those involved, including the national standards organizations (namely DIN), is to combat the corona crisis as effectively and quickly as possible.

In detail, the following EN standards are concerned:

  • EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’
  • EN 166:2001 Personal eye-protection – Specifications
  • EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes
  • EN 455-2:2015 Medical gloves for single use – Part 2: Requirements and testing for physical properties
  • EN 455-3:2015 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
  • EN 455-4:2009 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination
  • 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 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 14683:2019 Medical face masks – Requirements and test method

Link to the document: List of technical standards

Result: The current conversion of numerous product lines, for example in textile and shoe factories (and in many other companies), is supported by this measure of the European and national standardisation organisations and the Commission in an unbureaucratic manner. The relevant facilitation should also be seen in the light of the recent Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures of 13.03.2020. All in all, the players involved in product safety law are showing unprecedented flexibility – the manufacture, import and trade of medical equipment is becoming noticeably easier; nevertheless, any legal risks, for example in the rapid import of such products into the EU, should not be taken lightly.

Do you have any questions about this news or would you like to discuss the news with the author? You are welcome to contact: Dr. Carsten Schucht

23. March 2020 Dr. Carsten Schucht