Need help?

EN 556-1:2001/AC:2006 Standard

wave
Save  

  Keywords:

#devices #medical #european #standard #specifies

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This European Standard 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".

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 556-1:2001"

  Related Standards

EN 80601-2-58:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal d...

EN ISO 11607-2:2020

Medical devices Directive (93/42/EEC)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN 14180:2003+A2:2009

Medical devices Directive (93/42/EEC)

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

EN 14683:2019+AC:2019

Medical devices Directive (93/42/EEC)

Medical face masks - Requirements and test methods

EN ISO 15747:2019

Medical devices Directive (93/42/EEC)

Plastic containers for intravenous injections (ISO 15747:2018)

EN ISO 15883-4:2018

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 556-1:2001/AC:2006 STANDARD

  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