Need help?

EN ISO 10993-17:2023 Standard

wave
Save  

  Keywords:

#chemical #described #process #exposure #apply

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Tuesday 8th of April 2025

  Description:

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

  Purpose

ISO 10993-17 specifies the process and requirements for the toxicological risk assessment of medical device constituents to be used in the final product's biological evaluation (described in ISO 10993-1). It includes the methods and criteria used to assess if exposure to a chemical constituent is without appreciable harm.The process described in this standard is intended to apply after chemical characterization compositional profiling is performed as required by ISO 10993-18. Thus a toxicological risk assessment of either the compositional information, extractable data or leachable data is required to conclude if the risks related to the constituents are acceptable or not.The process described in ISO 10993-17 is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:— constituents, excluding cohort of concern or excluded chemicals, that are present or extracted at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold.— a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device.The process described in ISO 10993-17 is also not applicable to:— medical device constituents that do not contact the body,— all biological risks applicable to a medical device provided that the chemical exposure is unchanged,— active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations may apply,— exposure to a particular chemical constituent that arises from sources other than the device, such as food, water, or air.The text of ISO 10993-17:2023 has been approved in Europe as EN ISO 10993-17:2023 without any changes.

  Publication

Friday 8th of March 2024

  Related Standards

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 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

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 17664-2:2023

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

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