BS EN ISO 13485:2001

BS EN ISO 13485:2001


Full Specification Given Below:

Standard BS EN ISO 13485:2001
Title Identifier Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001
Status CU
Publication Date 15/03/01
Committee CH/210/1
Approximate Price 64.00
Notes Also available as part of KIT 160.
ISBN 0 580 36992 7
Pages 20
International Equivalent EN ISO 13485:2000 ISO 13485:1996
Descriptors Medical equipment, Medical instruments, Quality assurance systems, Quality assurance, Quality, Design, Installation, Maintenance, Production management
Cross references EN ISO 8402:1995, ISO 8402:1994, EN ISO 9001:1994, ISO 9001:1994, ISO 1137:1995
Replaces BS EN 46001:1997
Replaces Notes Replaces BS EN 46001:1997 which remains current.
Replaced By BS EN ISO 13485:2003
Replaced by Notes Replaced by BS EN ISO 13485:2003 but remains current.


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