Need help?

EN 14180:2003+A2:2009 Standard

wave
Save  

  Keywords:

#sterilization #european #sterilizing #requirements #standard

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 14180:2003"

  Related Standards

EN ISO 80601-2-55:2018

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory ga...

EN 1640:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Equipment

EN ISO 25424:2019

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-3:2006

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

  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 14180:2003+A2:2009 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