ISO13485:2001

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ISO Standards: ISO13485:2001



Standard Number ISO13485:2001
Standard Title Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001
Published On 15/03/01
Approx Page Count 20
Standard Description Medical equipment, Medical instruments, Quality assurance systems, Quality assurance, Quality, Design, Installation, Maintenance, Production management
Cross Ref EN ISO8402:1995, ISO8402:1994, EN ISO9001:1994, ISO9001:1994, ISO1137:1995
Replaces the Following : BS EN 46001:1997
Replacement Note Replaces BS EN 46001:1997 which remains current.
Replacement ISO13485:2003
Replacement Note 1 Replaced by ISO13485:2003 but remains current.
Original Committee CH/210/1
ISB Number 058036992 7
Other Equivalent EN ISO13485:2000 ISO13485:1996


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