News Local Coronavirus: Free access to European standards for personal protective equipment, medical devices

Coronavirus: Free access to European standards for personal protective equipment, medical devices

The rapid spread of COVID-19 and the unprecedented times at national, European and international level, require drastic measures and the contribution of everybody, to tackle this pandemic and reduce its rate of spreading, the Cyprus Organisation for Standardisation (CYS) has announced.

To contribute to this effort, the European Standardisation Organisations CEN & CENELEC and their national member bodies, such as the CYS, in cooperation with the EU, have decided to make available for a limited period of time to all stakeholders, free of charge, a significant number of European standards related to personal protective equipment and medical devices.

The purpose of this decision is to ensure that all interested parties (manufacturers, importers, competent authorities, etc.) have free access to these standards, some of which are harmonised with the relevant European legislation, so as to ensure that personal protective equipment and medical devices placed on the market and used by healthcare professionals, workers and consumers, meet the relevant safety requirements.

At the same time, the European Commission seeks to facilitate the work of many companies within the European Economic Area which are reconverting their production lines to deliver tangible results quickly and ensure that healthcare professionals and patients, have access to the necessary equipment they urgently need.

CYS is at the disposal of any interested party to contribute to this pan-European initiative by making available free of charge, the following standards:

  • CYS EN 149:2001 + A1:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’)
  • CYS EN 14683:2019 Medical face masks – Requirements and test methods
  • CYS EN 166:2001 Personal eye-protection – Specifications
  • CYS EN 14126:2003 + AC 2004 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
  • CYS 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
  • CYS EN 13795-1:2019 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
  • CYS 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
  • CYS EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (MDD)
  • CYS EN 455-2:2015 Medical gloves for single use – Part 2: Requirements and testing for physical properties (MMD)
  • CYS EN 455-3:2015 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (MDD)
  • CYS EN 455-4:2009 Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (MDD)
  • CYS EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks
  • CYS EN ISO 13688:2013 Protective clothing – General requirements
  • CYS EN ISO 10993-1:2009 + AC 2010 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

 

Interested parties in Cyprus can obtain these standards by contacting the Customer Service and Information Centre of CYS, either by calling at 22411413 or by sending an email to [email protected]

 

IMPORTANT CLARIFICATION:

Since a few fellow citizens have contacted CYS to obtain products to which the above standards refer to, it is clarified that the Cyprus Organisation for Standardisation does not supply, sell or offer personal protective equipment and medical devices. This Press Release refers to the provision of standards, without charge, which are useful for the manufacturing and circulation of such products by manufacturers or traders or for the information of the competent authorities.

Such products are usually sold by pharmacies and other points of sale, owned by private enterprises.

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