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EN 62366:2008 Standard

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  Keywords:

#amendment #medical #devices #application #usability

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

Medical devices - Application of usability engineering to medical devicesIEC 62366:2007

  Purpose

Amendment to EN 62366:2008

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 13408-7:2015

In vitro diagnostic medical devices Directive (98/79/EC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN 556-1:2001/AC:2006

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 17511:2003

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

EN ISO 15223-1:2016

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Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 15197:2015

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitu...

EN ISO 15194:2009

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified refer...

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