Need help?

EN ISO 10993-18:2020 Standard

wave
Save  

  Keywords:

#amendment #main #medical #text #can

This standard can be totally or partially supervised by:
  •   EN ISO 10993-18:2020/A1:2023
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Thursday 11th of June 2026

      Description:

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

      Purpose

    The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN ISO 10993-18:2020/A1:2023 modifies the European standard EN ISO 10993-18:2020. In this amendment, you can find the relationship between EN ISO 10993-18:2020 and the General Safety and Performance Requirements of Regulation (EU) 2017/745.

      Publication

    Friday 8th of March 2024

      Related Standards

    EN ISO 11137-1:2015/A2:2019

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

    EN ISO 11137-1:2015

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

    EN ISO 10993-4:2017

    Medical devices Regulation ((EU) 2017/745)

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

    EN ISO 7197:2024

    Medical devices Regulation ((EU) 2017/745)

    Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

    EN 14180:2025

    Medical devices Regulation ((EU) 2017/745)

    Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

    EN 14683:2025

    Medical devices Regulation ((EU) 2017/745)

    Medical face masks - Requirements and test methods

      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