DS/EN ISO 13485:2003 ( Withdrawn )

Medical devices - Quality management systems - System requirements for regulatory purposes

Status:

Withdrawn

Type:

Standard

Language:

English

Replaced by:

DS/EN ISO 13485:2012

Price from:

€ 96.65

Scope

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Replaces:

DS/EN ISO 13485:2001
DS/EN ISO 13488:2001
DS/EN 46003:1999

Number of pages: 57

Published: 2003-09-12

Date of approval: 2003-08-29

Date of withdrawal: 2012-03-09

International relationships : EN ISO 13485:2003 IDT ISO 13485:2003 IDT

ICS: 03.100.70 - Management systems 03.120.10 - Quality management and quality assurance 11.040.01 - Medical equipment in general

Item number: 47325

Committees

Committee

CEN/CS
ISO/TC 210

DS/EN ISO 13485:2003 ( Withdrawn )

Scope

Replaces:

Committees

Andre relevante standarder