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EN 14254:2004 Standard

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  Keywords:

#evacuated #purposes #blood #specimens #derived

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

  Purpose

This standard specifies requirements and test methods for evacuated and non-evacuated single-use specimen receptacles intended by their manufactures for the primary containment and preservation of spectimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.

  Publication

Friday 17th of November 2017

  Related Standards

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EN ISO 13485:2016/AC:2016

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

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EN 14820:2004

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

Single-use containers for human venous blood specimen collection

EN ISO 15197:2015

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

EN ISO 13485:2016/AC:2018

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

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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