Need help?

EN ISO 10993-23:2021 Standard

wave
Save  

  Keywords:

#vitro #test #silico #methods #dermal

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 5th of July 2023

  Description:

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

  Purpose

ISO 10993-23 specifies the procedure for the assessment of medical devices regarding their potential to produce irritation by using an in vitro reconstructed human epidermis model. The tests included in the standard are important tools for the development of safe products.ISO 10993-23 includes:— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure,— details of in vitro and in vivo irritation test procedures,— key factors for the interpretation of the results.The text of ISO 10993-23:2021 has been approved in Europe as EN ISO 10993-23:2021 without any changes.

  Publication

Monday 19th of July 2021

  Related Standards

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 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 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)

EN ISO 14160:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues...

EN ISO 13408-6:2021

Medical devices Regulation ((EU) 2017/745)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

  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