Need help?

EN 556-2:2024 Standard

wave
Save  

  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 13408-6:2021

Medical devices Regulation ((EU) 2017/745)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

EN ISO 14160:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues...

EN IEC 60118-0:2024

Medical devices Regulation ((EU) 2017/745)

Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids

EN IEC 60601-2-83:2020/A11:2021

Medical devices Regulation ((EU) 2017/745)

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light the...

EN IEC 60601-2-83:2020

Medical devices Regulation ((EU) 2017/745)

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light the...

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...

  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