Need help?

EN 285:2006 +A2:2009 Standard

wave
Save  

  Keywords:

#loads #metal #european #test #medical

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Sterilization - Steam sterilizers - Large sterilizers

  Purpose

his European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 285:2006"

  Reference

This standard superseed the "EN 285:2006 +A1:2008".

Anyway is still possible use the "EN 285:2006 +A1:2008" until March 21st, 2010

  Related Standards

EN 1060-4:2004

Medical devices Directive (93/42/EEC)

Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygm...

EN 20594-1:1993

Medical devices Directive (93/42/EEC)

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

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

EN ISO 16201:2006

Medical devices Directive (93/42/EEC)

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

EN ISO 17664:2004

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

EN ISO 17665-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

  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 285:2006 +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