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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

Wednesday 28th of January 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

EN ISO 11607-1:2020

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 13485:2016/A11:2021

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

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

EN ISO 18113-5:2024

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

EN ISO 18113-4:2024

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents ...

EN ISO 18113-3:2024

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instrumen...

EN ISO 18113-2:2024

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

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