Need help?

EN ISO 15883-2:2009 Standard

wave
Save  

  Keywords:

#disinfectors #dishes #devices #surgical #instruments

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)

  Purpose

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 15883-2:2006"

Anyway is still possible use the "EN ISO 15883-2:2006" until March 21st, 2010

  Related Standards

EN ISO 25539-2:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

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 10993-4:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-5:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-6:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 10993-7:2008

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

  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 ISO 15883-2:2009 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