Need help?

EN ISO 10993-9:2021 Standard

wave
Save  

  Keywords:

#document #described #can #biological #mechanical

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 5th of July 2023

  Description:

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

  Purpose

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.This document is not applicable to:a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.b) leachable components which are not degradation products;c) medical devices or components that do not contact the patient's body directly or indirectly.

  Publication

Wednesday 5th of January 2022

  Related Standards

EN ISO 15223-1:2021

Medical devices Regulation ((EU) 2017/745)

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223...

EN ISO 11135:2014/A1:2019

Medical devices Regulation ((EU) 2017/745)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 10993-10:2023

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

EN ISO 17664-1:2021

Medical devices Regulation ((EU) 2017/745)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

EN ISO 14971:2019/A11:2021

Medical devices Regulation ((EU) 2017/745)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

EN ISO 14971:2019

Medical devices Regulation ((EU) 2017/745)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

  Stay up to date

  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