BS EN 62304:2006

BS EN 62304:2006 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks,described in this standard establishes a common framework for medical device software life cycle processes.

BS EN 62304:2006 applies to the development and maintenance of medical device software whensoftware is itself a medical device or when software is an embedded or integral part of the finalmedical device.

BS EN 62304:2006 does not cover validation and final release of the medical device, even when themedical device consists entirely of software.

This medical device software life cycle standard is to be used together with other appropriate standards when developing a medical device. Hannax shows the relationship between this standard and other relevant standards.

Compliance with BS EN 62304:2006 is defined as implementing all of the processes, activities, and tasks identified in this standard in accordance with the software safety class.

NOTE The software safety classes assigned to each requirement are identified in the normative text following the requirement. Compliance is determined by inspection of all documentation required by this standard including the risk management file, and assessment of the processes, activities, and tasks required for the software safety class. See Hannex D.

NOTE 1 This assessment could be carried out by internal or external audit.

NOTE 2 Although the specified processes, activities, and tasks are performed, flexibility exists in the methods of implementing these processes and performing these activities and tasks.

NOTE 3 Where any requirements contain as appropriate and were not performed, documentation for the justification is necessary for this assessment.

NOTE 4 The term conformance is used in ISO/IEC 12207 where the term compliance is used in this standard.



Cross References:
ISO 14971
EN ISO 14971:2000
IEC 60601-1:2005
IEC 60601-1-4:1996
IEC 60601-1-4:1996/AMD 1:1999
EN 60601-1-4:1996
EN 60601-1-4:1996/A1:1999
IEC 61508-3
EN 61508-3:2001
IEC 61010-1:2001
EN 61010-1:2001
ISO 9000:2005
EN ISO 9000:2005
ISO 9001:2000
EN ISO 9001:2000
ISO 13485:2003
EN ISO 13485:2003
ISO/IEC 9126-1:2001
ISO/IEC 12207:1995
ISO/IEC 12207:1995/AMD 1:2002
ISO/IEC 12207:1995/AMD 2:2004
ISO/IEC 14764:1999
ISO/IEC 90003:2004
ISO/IEC Guide 51:1999
IEEE 610.12:1990
IEEE 1044:1993
IEC 60601-1-6
EN 60601-1-6:2004




Keywords: Electrical medical equipment; Electrical equipment; Medical equipment ; Computer software; Life cycle; Life (durability); Design; Maintenance; Equipment safety; Safety measures; Hazards; Software engineering techniques; Computer technology; Quality management; Risk assessment; Identification methods; Quality assurance systems

Product Code(s): 30193862,30193862

This product references:BS EN 61010-1:2001 - Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements
BS EN ISO 9000:2005 - Quality management systems. Fundamentals and vocabulary
ISO 9001:2000 - Quality management systems -- Requirements
BS EN ISO 9001:2000 - Quality management systems. Requirements
BS EN ISO 13485:2003 - Medical devices. Quality management systems. Requirements for regulatory purposes
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO/IEC Guide 51:1999 - Safety aspects -- Guidelines for their inclusion in standards
ISO/IEC 90003:2004 - Software engineering - Guidelines for the application of ISO 9001:2000 to computer software
ISO/IEC 14764:1999 - Information technology -- Software maintenance
ISO/IEC 12207:1995 - Information technology - Software life cycle processes
ISO/IEC 9126-1:2001 - Software engineering -- Product quality -- Part 1: Quality model
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
BS EN 60601-1-6:2004 - Medical electrical equipment. General requirements for safety. Collateral standard. Usability
This product is related to: SEPT CM Template - Product 76 - Templates for Software Configuration
SEPT IEC 62304 CHECKLIST - Prod 40 - Medical device software. Software life-cycle processes
This product referenced by:BS EN 60601-1:2006 - Medical device software. Software life-cycle processes
BS EN 60601-1-10:2008 - Medical device software. Software life-cycle processes
BS EN 80001-1:2011 - Medical device software. Software life-cycle processes
BS 11/30237926 DC - Medical device software. Software life-cycle processes
BS EN 62083:2009 - Medical device software. Software life-cycle processes
BS 11/30252448 DC - Medical device software. Software life-cycle processes
BS EN 60601-1:2006 A11:2011 - Medical device software. Software life-cycle processes
BS 12/30262894 DC - Medical device software. Software life-cycle processes

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