NF EN ISO 15225/A1

NF EN ISO 15225/A1

September 2004
Standard Cancelled

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Le présent document modifie les paragraphes 5.2.2, 5.2.3, 6.1.6.3 et l'annexe B.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

September 2004

Number of pages

10 p.

Reference

NF EN ISO 15225/A1

ICS Codes

11.040.01   Medical equipment in general
35.240.80   IT applications in health care technology

Classification index

S99-012/A1

Print number

1 - 15/09/2004

International kinship

ISO 15225/A1:2004

European kinship

EN ISO 15225/A1:2004
Sumary
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

Le présent document modifie les paragraphes 5.2.2, 5.2.3, 6.1.6.3 et l'annexe B.
Standard replaced by (1)
NF EN ISO 15225
August 2010
Standard Cancelled
Medical devices - Quality management - Medical device nomenclature data structure

ISO 15225:2010 provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users. ISO 15225:2010 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein. The requirements contained in ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification. ISO 15225:2010 does not include the nomenclature itself, which is provided as a data file.

Table of contents
  • Avant-propos
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive Machines 93/42/CEE
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!
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