Need help?

EN ISO 10993-10:2023 Standard

wave
Save  

  Keywords:

#device #intended #factors #includes #experience

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 5th of July 2023

  Description:

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

  Purpose

EN ISO 10993-10 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. EN ISO 10993-10 includes essential tools for the development of safe products. It is intended to be used by professionals, appropriately qualified by training and experience, who can interpret its requirements and judge the outcomes of the evaluation for each medical device.It is crucial to consider all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by the review of the scientific literature and previous clinical experience. EN ISO 10993-10 includes:—    details of in vivo skin sensitization test procedures,—    key factors for the interpretation of the results.The text of ISO 10993-10:2021 has been approved in Europe as EN ISO 10993-10:2023 without any changes.

  Publication

Wednesday 5th of July 2023

  Related Standards

EN ISO 10993-9:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 13485:2016

Medical devices Regulation ((EU) 2017/745)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 25424:2019

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

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 15223-1:2021

Medical devices Regulation ((EU) 2017/745)

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223...

EN ISO 14971:2019/A11:2021

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