BS EN ISO 13485:2003

BS EN ISO 13485:2003


Full Specification Given Below:

Standard BS EN ISO 13485:2003
Title Identifier Medical devices. Quality management systems. Requirements for regulatory purposes
Status CU
Publication Date 24/07/03
Committee CH/210/1
Approximate Price 140.00
Notes
ISBN 0 580 42306 9
Pages 72
International Equivalent EN ISO 13485:2003 ISO 13485:2003
Descriptors Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management
Cross references ISO 9001:2000, ISO 10012, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13641:2002, ISO 13683:1997, ISO 14155-1:2003, ISO 14155-2:2003, ISO 14160:1998, ISO 14937:2000, ISO/TR 14969, ISO 14971:2000, ISO 19011:2002, 93/42/EEC, ISO 9000:2000, EN ISO 9000:2000
Replaces BS EN ISO 13485:2001 BS EN ISO 13488:2001
Replaces Notes Replaces BS EN ISO 13485:2001 and BS EN ISO 13488:2001 which remain current.
Replaced By
Replaced by Notes


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