Need help?

EN ISO 10993-23:2021 Standard

wave
Save  

  Keywords:

#vitro #reconstructed #human #epidermis #model

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 16th of July 2021

  Description:

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

  Purpose

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

  Publication

Friday 16th of July 2021

  Related Standards

EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipmentIEC 60601-2-11:199...

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

EN ISO 3826-4:2015

Medical devices Directive (93/42/EEC)

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated featur...

EN ISO 5840:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 9360-2:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HME...

  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 10993-23:2021 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