ISO 10993-10:2021
ISO 10993-10:2021

ISO 10993-10:2021

November 2021
International standard Current

Biological evaluation of medical devices - Part 10: Tests for skin sensitization

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.This document includes:—    details of in vivo skin sensitization test procedures;—    key factors for the interpretation of the results.NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

See more
View the extract
Main informations

Collections

International ISO standards

Publication date

November 2021

Number of pages

51 p.

Reference

ISO 10993-10:2021

ICS Codes

11.100.20   Biological evaluation of medical devices

Print number

1
Sumary
Biological evaluation of medical devices - Part 10: Tests for skin sensitization

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

—    details of in vivo skin sensitization test procedures;

—    key factors for the interpretation of the results.

NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Replaced standards (1)
ISO 10993-10:2010
ISO 10993-10:2010
August 2010
International standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization

ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

ZOOM ON ... the Requirements department

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:

  • mandatory clauses to satisfy,
  • non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document "ISO/IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents" as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!


What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.


The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ