© British Standards Institution 2025
Site Map
Standard
Withdrawn

BS EN 46001:1997

Specification for application of EN ISO 9001 to the manufacture of medical devices

Published:

15 Feb 1997

•

Withdrawn:

1 Feb 2004

Overview
Preview
References
History
Visit the preview section for more information
Product Details
Descriptors
Medical instruments
Quality assurance
Quality assurance systems
Quality control
Production management
Medical equipment
ICS Codes
03.120.10 Quality management and quality assurance
11.040.01 Medical equipment in general
Committee
CH/210/1
International relationships
Identical to:

EN 46001:1996

ISBN
0 580 27045 9
Publisher
BSI