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Free access in read - only format to CEN and ISO documents for medical devices and personal protective equipment

Free access in read - only format to CEN and ISO documents for medical devices and personal protective equipment

 

The Bulgarian Institute for Standardization provides free access to the following CEN and ISO documents in read-only format for medical devices and personal protective equipment:

 

  •  BDS EN ISO 10993-1:2010 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
  • BDS EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk (ISO 374-5:2016)
  • BDS EN ISO 13688:2013 Protective clothing – General requirements (ISO 13688:2013)
  • BDS EN ISO 5356-1:2015 Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2015)
  • BDS EN ISO 10651-4:2010 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
  • BDS EN ISO 18082:2014 Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014)
  • BDS EN ISO 80601-2-79:2019 Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
  • BDS EN ISO 80601-2-80:2019 Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)

 

The free access is based on PC Decision 15/2020 to make available CEN and CENELEC standards necessary to facilitate alternative production of personal protective equipment and medical devices urgently needed in the battle against the COVID-19 pandemic. As the standards are developed jointly with ISO, ISO guidelines for access in read-only format are respected.

 

The standards are accessible in read-only format on BDS website after registration.

 

Related to the COVID-19 crisis, a request was made by the ISO members and by regional standardization organizations a decision to be made a number of ISO standards to be with free access in support of global efforts to handle the effects of the crisis on companies and organizations. Following consultations with the ISO President and the Chair of the Commercial Policy Advisory Group, it was decided ISO to provide access in read-only format. The standards are available at the following link: https://www.iso.org/covid19

20 Aug 2020