Need help?

EN ISO 10993-5:2009 Standard

wave
Save  

  Keywords:

#methods #device #cells #biological #evaluation

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-5:1999"

Anyway is still possible use the "EN ISO 10993-5:1999" until December 31st, 2009

  Related Standards

EN ISO 15004-1:2009

Medical devices Directive (93/42/EEC)

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic ins...

EN 13726-2:2002

Medical devices Directive (93/42/EEC)

Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings

EN ISO 14630:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - General requirements (ISO 14630:2008)

EN ISO 14602:2011

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

EN 14563:2008

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activi...

EN 14562:2006

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for in...

  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 10993-5:2009 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