Need help?

EN 556-1:2024 Standard

wave
Save  

  Keywords:

#iso #device #medical #devices #requirements

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 2026

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

  Purpose

This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE  For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.

  Publication

Tuesday 8th of April 2025

  Related Standards

EN 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 17664-1:2021

Medical devices Regulation ((EU) 2017/745)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

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 18562-4:2024

Medical devices Regulation ((EU) 2017/745)

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

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 18562-2:2024

Medical devices Regulation ((EU) 2017/745)

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matt...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0