NF EN ISO 10993-10

NF EN ISO 10993-10

September 2009
Standard Cancelled

Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

Le présent document décrit le mode opératoire visant à évaluer le potentiel des dispositifs médicaux et leurs matériaux constitutifs à provoquer de l'irritation et une hypersensibilité retardée.Les normes de la série EN ISO 10993 sur l'évaluation biologique des dispositifs médicaux ont le statut de normes harmonisées et viennent en appui aux Directives européennes sur les dispositifs médicaux.Les Directives 93/42/CE sur les dispositifs médicaux et 90/385CE sur les dispositifs médicaux implantables actifs ayant été modifiées par la Directive 2007/47/CE il a été nécessaire de préparer des nouvelles versions des annexes ZA et ZB donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées.

See more
View the extract New: UPSELL service
Main informations

Collections

National standards and national normative documents

Publication date

September 2009

Number of pages

66 p.

Reference

NF EN ISO 10993-10

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-10

Print number

1 - 17/09/2009

International kinship

ISO 10993-10:2002

European kinship

EN ISO 10993-10:2009
Sumary
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

Le présent document décrit le mode opératoire visant à évaluer le potentiel des dispositifs médicaux et leurs matériaux constitutifs à provoquer de l'irritation et une hypersensibilité retardée. Les normes de la série EN ISO 10993 sur l'évaluation biologique des dispositifs médicaux ont le statut de normes harmonisées et viennent en appui aux Directives européennes sur les dispositifs médicaux. Les Directives 93/42/CE sur les dispositifs médicaux et 90/385CE sur les dispositifs médicaux implantables actifs ayant été modifiées par la Directive 2007/47/CE il a été nécessaire de préparer des nouvelles versions des annexes ZA et ZB donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées.
Replaced standards (2)
NF EN ISO 10993-10
February 2003
Standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results. Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.

NF EN ISO 10993-10/A1
October 2006
Standard Cancelled
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity

Le présent document apporte des précisions et/ou modifications sur certaines parties de la norme NF EN ISO 10993 de février 2003.

Standard replaced by (1)
NF EN ISO 10993-10
December 2010
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!

With Requirements, quickly access the main part of the normative text!
New: UPSELL service
- The UPSELL service allows you to easily update one of your standards.
- With a single click, add a new language, the Requirements or Redline+ service and add one or more additional users.
- Whether you are in the process of acquiring a standard or it is already available in your personal space, the UPSELL service is available at every stage to help you understand it and implement it within your organization.
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