Need help?

EN ISO 10993-6:2009 Standard

wave
Save  

  Keywords:

#solid #part #materials #liquids #degradable

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are: - solid and non-biodegradable; - degradable and/or resorbable; - non-solid, such as porous materials, liquids, pastes and particulates.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-6:2007"

Anyway is still possible use the "EN ISO 10993-6:2007" until March 21st, 2010

  Related Standards

EN ISO 13408-3:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

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 10524-3:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN ISO 10535:2006

Medical devices Directive (93/42/EEC)

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

EN ISO 10555-1:2009

Medical devices Directive (93/42/EEC)

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

  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 10993-6:2009 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