Need help?

EN ISO 10993-3:2014 Standard

wave
Save  

  Keywords:

#part #tests #selection #risk #biological

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

  Purpose

This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. NOTE Guidance on selection of tests is provided in ISO 10993-1.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-3:2009"

Anyway is still possible use the "EN ISO 10993-3:2009" until November 17th, 2017

  Related Standards

EN ISO 15223-1:2016

Medical devices Directive (93/42/EEC)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 11140-1:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 13408-2:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

EN ISO 13408-1:2015

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN 13060:2014

Medical devices Directive (93/42/EEC)

Small steam sterilizers

EN 12470-5:2003

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

  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 10993-3:2014 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