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  3. AAMI/IEC 62304:2006 PDF

AAMI/IEC 62304:2006 PDF

AAMI/IEC 62304:2006 PDF

Name:
AAMI/IEC 62304:2006 PDF

Published Date:
07/19/2006

Status:
Active

Description:

Medical device software - Software life cycle processes

Publisher:
Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$73.2
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Specifies life cycle processes including software development, software maintenance, software risk management, software configuration management, and software problem resolution requirements for medical device software. Also requires manufacturers to assign one of three defined safety classes to the software system, and makes normative reference to ANSI/AAMI/ISO 14971, Application of risk management to medical devices.

New! IEC 62304:2006 Checklist also available for purchase.
ANSI : ANSI Approved
File Size : 1 file , 1.1 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 83
Published : 07/19/2006
Same As : AAMI/IEC 62304:2006

History

AAMI/IEC 62304:2006 & A1:2016
AAMI/IEC 62304:2006 & A1:2016
Published Date: 04/07/2016
Medical device software - Software life cycle processes - Consolidated Text
$82.5
AAMI/IEC 62304:2006
AAMI/IEC 62304:2006
Published Date: 07/19/2006
Medical device software - Software life cycle processes
$73.2

Related products

AAMI/IEC 62304:2006 & A1:2016
AAMI/IEC 62304:2006 & A1:2016
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Medical device software - Software life cycle processes - Consolidated Text
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