NF EN ISO 10993-1

January 2004

Standard Cancelled

Biological evaluation of medical devices — Part 1: Evaluation and testing

View the extract New: UPSELL service

Main informations

Collections

National standards and national normative documents

Publication date

January 2004

Number of pages

24 p.

Reference

NF EN ISO 10993-1

ICS Codes

11.040.01 Medical equipment in general

11.100.20 Biological evaluation of medical devices

International kinship

ISO 10993-1:2003

European kinship

EN ISO 10993-1:2003

Sumary

Biological evaluation of medical devices — Part 1: Evaluation and testing

Le présent document décrit les principes fondamentaux sur lesquels repose l''évaluation biologique des dispositifs médicaux. Il définit les classes de dispositifs basées sur la nature et la durée de contact avec le corps humain, et décrit le choix des essais appropriés.

Replaced standards (1)

NF EN ISO 10993-1

February 1998

Standard Cancelled

Biological evaluation of medical devices. Part 1 : evaluation and testing.

Standard replaced by (1)

NF EN ISO 10993-1

January 2009

Standard Cancelled

Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)

Le présent document décrit les principes fondamentaux sur lesquels repose l''évaluation biologique des dispositifs médicaux. Il définit les classes de dispositifs basées sur la nature et la durée de contact avec le corps humain, et décrit le choix des essais appropriés. 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 les annexes ZA et ZB donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées.

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