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EN 14254:2004 Standard

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  Keywords:

#evacuated #standard #specifies #requirements #test

  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

EN 556-1:2001

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

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

EN 556-2:2015

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Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 11737-2:2009

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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

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