Need help?

EN ISO 10993-9:2009 Standard

wave
Save  

  Keywords:

#part #studies #resorbable #biodegradation #framework

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

  Purpose

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials.

  Publication

Friday 17th of November 2017

  Related Standards

EN 13976-2:2018

Medical devices Directive (93/42/EEC)

Rescue systems - Transportation of incubators - Part 2: System requirements

EN 556-2:2015

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN ISO 18777:2009

Medical devices Directive (93/42/EEC)

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

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...

EN ISO 17510-2:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

EN ISO 17510-1:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

  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 10993-9:2009 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