NF EN 45502-1

NF EN 45502-1

May 2016
Standard Current

Implants for surgery - Active implantable medical devices - Part 1 : general requirements for safety, marking and for information to be provided by the manufacturer

Le présent document spécifie les exigences généralement applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS.Le présent document entre dans le champ d'application de la Directive n° 90/385/CEE du 20/06/1990 concernant le rapprochement des législations des Etats membres relatives aux dispositifs médicaux implantables actifs.

See more
View the extract New: UPSELL service
Main informations

Collections

National standards and national normative documents

Publication date

May 2016

Number of pages

75 p.

Reference

NF EN 45502-1

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics
11.040.60   Therapy equipment

Classification index

C74-502-1

Print number

1

European kinship

EN 45502-1:2015
Sumary
Implants for surgery - Active implantable medical devices - Part 1 : general requirements for safety, marking and for information to be provided by the manufacturer

Le présent document spécifie les exigences généralement applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS. Le présent document entre dans le champ d'application de la Directive n° 90/385/CEE du 20/06/1990 concernant le rapprochement des législations des Etats membres relatives aux dispositifs médicaux implantables actifs.
Replaced standards (1)
NF EN 45502-1
November 1998
Standard Cancelled
Active implantable medical devices. Part 1 : general requirements for safety, marking and information to be provided by the manufacturer.

Cette partie 1 de l'EN 45502 spécifie les exigences généralement applicables aux DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS. Les exigences essentielles relatives à des types spéciaux de DISPOSITIFS MÉDICAUX IMPLANTABLES ACTIFS sont complétées ou modifiées par les exigences des normes particulières, qui sont regroupées dans les parties additionnelles de cette norme.

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!
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.
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
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