DS/EN ISO 13485:2003 ( Withdrawn )

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

Status:
Withdrawn
Type:
Standard
Language:
English
Replaced by:
Price from:
€ 96.56

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:

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

Item number: 47325

Committees

Committee

  • CEN/CS
  • ISO/TC 210

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