Need help?

EN 556-1:2001/AC:2006 Standard

wave
Save  

  Keywords:

#devices #medical #european #standard #specifies

  This standard is no longer addressed in the last official Journal publication of the "2022-01-05 ". This standard is addressed for the last time in the official journal publication of the "2022-01-05"

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 5th of January 2022

  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 ISO 11137-1:2015

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 18778:2009

Medical devices Directive (93/42/EEC)

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

EN ISO 15798:2010

Medical devices Directive (93/42/EEC)

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

EN ISO 15883-2:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instrumen...

EN ISO 15883-3:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste contai...

EN 15986:2011

Medical devices Directive (93/42/EEC)

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

  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