IEC
62304

Reference

Software Lifecycle
Process

Applicable
for

Class

A

Class

B

Class

C

　

PRIMARY
LIFECYCLE PROCESESS

　

　

　

5

SOFTWARE
DEVELOPMENT Process

　

　

　

5.1

Development Planning
Activity

　

　

　

5.1.1

Software
development plan task

X

X

X

5.1.2

Software
development plan reference to SYSTEM requirements task

X

X

X

5.1.3

SOUP management
planning task

　

X

X

5.1.4

Software
development measures planning task

　

X

X

5.1.5

Software
integration and integration testing planning task

　

X

X

5.1.6

Software
VERIFICATION planning task

X

X

X

5.1.7

Software
VERIFICATION requirements coverage planning task

　

X

X

5.1.8

Software RISK
MANAGEMENT planning task

X

X

X

5.1.9

Documentation
planning task

X

X

X

5.1.10

Software
configuration management planning task

X

X

X

5.1.11

Software
configuration control planning task

　

X

X

5.1.12

Software problem
resolution planning task

　

　

X

5.2

Requirements Analysis
Activity

　

　

　

5.2.1

Define software
requirements from SYSTEM requirements task

X

X

X

5.2.2

Establish
software requirements task

X

X

X

5.2.3

Software
requirements content task

X

X

X

5.2.4

Include RISK
CONTROL measures in software requirements task

　

X

X

5.2.5

Update RISK
ANALYSIS task

X

X

X

5.2.6

Ensure
compliance with SYSTEM requirements task

X

X

X

5.2.7

Uniquely
identify software requirements task

X

X

X

5.2.8

Update SYSTEM
requirements task

X

X

X

5.2.9

Verify software
requirements task

X

X

X

5.2.10

Document
software requirements VERIFICATION task

X

X

X

5.3

Architectural Design
Activity

　

　

　

5.3.1

Transform
software requirements into an ARCHITECTURE task

X

X

X

5.3.2

Document
software ARCHITECTURE task

X

X

X

5.3.3

Document
software safety classification of each SOFTWARE ITEM
task

X

X

X

5.3.4

Develop an
ARCHITECTURE for the interfaces of SOFTWARE ITEMS task

　

X

X

5.3.5

Specify SYSTEM
hardware and software required by SOUP item task

　

X

X

5.3.6

Specify
functional and performance requirements of SOUP item
task

　

X

X

5.3.7

Identify
segregation necessary for SAFETY task

　

X

X

5.3.8

Verify software
ARCHITECTURE task

　

X

X

5.3.9

Verify
appropriateness of software development plan task

　

X

X

5.3.10

Document results
of software ARCHITECTURE VERIFICATION task

　

X

X

5.4

Detailed
Design Activity

　

　

　

5.4.1

Refine SOFTWARE
ITEMS into SOFTWARE UNITS task

　

X

X

5.4.2

Inheritance of
software safety classification task

　

X

X

5.4.3

Develop detailed
design for each SOFTWARE UNIT task

　

　

X

5.4.4

Develop detailed
design for interfaces task

　

　

X

5.4.5

Verify detailed
design task

　

X

X

5.4.6

Additional
detailed design VERIFICATION task

　

　

X

5.4.7

Document results
of design VERIFICATION task

　

X

X

5.5

Software
Coding Activity

　

　

　

5.5.1

Implement each
SOFTWARE UNIT task

　

X

X

5.5.2

Establish
SOFTWARE UNIT VERIFICATION PROCESS task

　

X

X

5.5.3

Verify software
code task

　

X

X

5.5.4

Additional
software code VERIFICATION task

　

X

X

5.5.5

Document the
results of software code VERIFICATION task

　

X

X

5.6

Integration and Testing
Activity

　

　

　

5.6.1

Integrate
SOFTWARE UNITS task

　

X

X

5.6.2

Verify software
integration task

　

X

X

5.6.3

Document the
results of software integration task

　

X

X

5.5.4

Additional
software code VERIFICATION task

　

X

X

5.6.5

Integration
testing content task

　

X

X

5.6.6

Include
integration testing for non-normal cases task

　

　

X

5.6.7

Conduct
regression tests task

　

X

X

5.6.8

Document results
of software integration tests task

　

X

X

5.6.9

Integration test
documentation contents task

　

X

X

5.6.10

Use formal
software problem resolution PROCESS task

　

X

X

5.7

System
Testing Activity

　

　

　

5.7.1

Establish tests
for each software requirement task

　

X

X

5.7.2

Use formal
software problem resolution PROCESS task

　

X

X

5.7.3

Repeat tests and
conduct regression tests task

　

X

X

5.7.4

Verify SOFTWARE
SYSTEM testing task

　

X

X

5.7.5

Record data for
each test task

　

X

X

5.8

Release
Activity

　

　

　

5.8.1

Ensure software
VERIFICATION is complete

　

X

X

5.8.2

Ensure
documentation is complete

　

X

X

5.8.3

Document known
residual anomalies

　

X

X

5.8.4

Evaluate known
residual anomalies

　

X

X

5.8.5

Document
released VERSIONS

　

X

X

5.8.6

Document how
released software was created

　

X

X

5.8.7

Archive master
copies

　

X

X

5.8.8

Use established
procedures for software release

　

X

X

6

SOFTWARE
MAINTENANCE Process

　

　

　

6.1

Establish software
maintenance plan Activity

　

　

　

6.1.1

Establish
software maintenance plan task

X

X

X

6.2

Problem
and Modification Analysis Activity

　

　

　

6.2.1

Record and
evaluate feedback task

X

X

X

6.2.2

Use software
problem resolution PROCESS task

X

X

X

6.2.3

Analyse
modification requests task

X

X

X

6.2.4

Conduct analysis
of changes implied by modification request task

X

X

X

6.2.5

Document new,
modified and deleted item task

X

X

X

6.2.6

Review and
approve modification task

X

X

X

6.2.7

Document
modification task

　

X

X

6.3

Modification
Implementation Activity

　

　

　

6.3.1

Use established
PROCESS to implement modification task

X

X

X

6.3.2

Define criteria
for testing modifications task

　

X

X

6.3.3

Verify
modifications task

　

X

X

6.3.4

Conduct
regression testing task

　

X

X

6.3.5

Demonstrate
software RISK CONTROL measures remain effective task

　

X

X

6.3.6

Document the
test results task

　

X

X

see
5.3

Architectural Design
Activity

　

　

　

see
5.4

Detailed
Design Activity

　

　

　

see
5.5

Software
Coding Activity

　

　

　

see
5.6

Integration and Testing
Activity

　

　

　

see
5.7

System
Testing Activity

　

　

　

see
5.8

Release
Activity

　

　

　

　

SUPPORTING
PROCESSES

　

　

　

7

SOFTWARE
RISK MANAGEMENT Process (referenced ISO 14971)

　

　

　

7.1

Analysis
of software contributing to HAZARDS Activity

　

　

　

7.1.1

Identify
SOFTWARE ITEMS that could contribute to a HAZARD task

　

X

X

7.1.2

Identify
potential causes of contribution to a HAZARD task

　

X

X

7.1.3

Consider
specific potential causes task

　

X

X

7.1.4

Review published
SOUP anomaly lists task

　

X

X

7.1.5

Document
potential causes task

　

X

X

7.1.6

Document
sequences of events task

　

X

X

7.2

RISK
CONTROL measures Activity

　

　

　

7.2.1

Define RISK
CONTROL measures task

　

X

X

7.2.2

RISK CONTROL
measures implemented in software task

　

X

X

7.3

VERIFICATION of RISK
CONTROL measures Activity

　

　

　

7.3.1

Verify RISK
CONTROL measures task

　

X

X

7.3.2

Document any new
sequences of events task

　

X

X

7.3.3

Document
TRACEABILITY task

　

X

X

7.4

RISK
MANAGEMENT of software changes Activity

　

　

　

7.4.1

Analyse changes
TO MEDICAL DEVICE SOFTWARE with respect to safety task

X

X

X

7.4.2

Analyse impact
software changes on existing RISK CONTROL measures task

　

X

X

7.4.3

Perform RISK
MANAGEMENT ACTIVITIES based on analyses task

　

X

X

8

SOFTWARE
CONFIGURATION MANAGEMENT Process

　

　

　

8.1

Configuration
identification Activity

　

　

　

8.1.1

Establish means
to identify CONFIGURATION ITEMS task

X

X

X

8.1.2

Identify SOUP
task

X

X

X

8.1.3

Document SOUP
designator task

X

X

X

8.1.4

Identify SYSTEM
configuration documentation task

X

X

X

8.2

Configuration control
Activity

　

　

　

8.2.1

Identify and
record change requests task

X

X

X

8.2.2

Approve requests
prior to implementation task

X

X

X

8.2.3

Implement
changes task

X

X

X

8.2.4

Provide means
for TRACEABILITY of change task

X

X

X

8.3

Configuration status
accounting Activity

　

　

　

8.3.1

Configuration
status accounting task

X

X

X

9

SOFTWARE
PROBLEM RESOLUTION Process

　

　

　

　

SOFTWARE
PROBLEM RESOLUTION Activity

　

　

　

9.1.1

Prepare problem
reports task

X

X

X

9.1.2

Advise relevant
parties task

X

X

X

9.1.3

Investigate the
problem task

X

X

X

9.1.4

Evaluate the
problem's relevance to safety task

X

X

X

9.1.5

Track and report
status task

X

X

X

9.1.6

Resolve the
problem task

X

X

X

9.1.7

Maintain a
record of the problem task

X

X

X

9.1.8

Analyse problems
for trends task

X

X

X

9.1.9

Verify
task

X

X

X

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