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EN 556-2:2024 Standard

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  Keywords:

#devices #medical #requirements #designated #part

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th 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

EN ISO 10993-4:2017

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

EN ISO 13485:2016

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 18562-3:2024

Medical devices Regulation ((EU) 2017/745)

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic...

EN ISO 18562-4:2024

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Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO...

EN ISO 21535:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:20...

EN ISO 21536:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...

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