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EN 556-2:2024 Standard

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  Keywords:

#devices #medical #requirements #designated #part

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Monday 15th of June 2026

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

  Purpose

This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

  Publication

Tuesday 8th of April 2025

  Related Standards

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EN 556-1:2024

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EN ISO 17665:2024

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EN ISO 18113-1:2024

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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and gener...

EN ISO 18113-2:2024

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