X-Ray Machine

Software development plan

Revision History

SL Rev. Section Date Summary of changes

No. Changed
1 00 - 02-01-2023 Initial creation

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 Contents
1. Introduction...................................................................................................................................................3
Purpose.......................................................................................................................................................3
Definition of Terms....................................................................................................................................3
References..................................................................................................................................................4
2. Project Overview...........................................................................................................................................4
Project Purpose and Scope.........................................................................................................................4
Assumptions and Constraints.....................................................................................................................4
3. Processes and Activities................................................................................................................................5
Processes....................................................................................................................................................5
Software Development Process.................................................................................................................5
Software Development Life Cycle Model.............................................................................................5
Project Deliverables...............................................................................................................................5
4. Organization Structure...................................................................................................................................6
5. Standards.......................................................................................................................................................7
6. Traceability....................................................................................................................................................7
7. Software Configuration and Change Management.......................................................................................7
8. Software Problem Resolution........................................................................................................................8

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1. Introduction
This document provides a development plan for the software to be developed for the X-Ray Machine. Its
objective is to lay out a plan for the various activities involved in the software development process.

Purpose
This plan establishes the activities involved in the software development process as well as define the software
development life cycle model to be used for the project. It defines the processes involved in the development of
the software system as well as identifies the deliverable of the activities involved in the processes.

Definition of Terms Activities

A set of one or more interrelated tasks. [EN IEC 62304: 2019, definition 3.1]

Process

A set of interrelated or interacting activities that use inputs to deliver an Intended output.
[ISO 81001-1, definition 3.38, modified]

Software Item

Any identifiable part of a software program. [ISO/IEC 12207:2017, definition 3.1.53]

Software System

Integrated collection of Software Items organized to accomplish a specific function or a set of functions.
[EN IEC 62304: 2019, definition 3.34]

System

Integrated composite consisting of one or more of the Processes, Hardware, Software, facilities and people,
that provides a capability to satisfy a stated need or objective.
[ISO 81001-1, definition 3.61, modified]

Task

A single piece of work that needs to be done [EN IEC 62304: 2019, definition 3.38]
References

[1] Design Inputs for X-Ray Machine.

[2] Software Requirements Specifications for X-Ray Machine.

[3] Project Plan for X-Ray Machine.

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 [4] Software Integration and Integration Testing Plan for X-Ray Machine.

[5] Software Verification Plan for X-Ray Machine.

[6] Software Configuration Management Plan for X-Ray Machine.

2. Project Overview
This project describes the design and prototyping of a portable X-Ray Machine for use in OT department.

Project Purpose and Scope

The software included in the medical device shall provide the interface for Atlas N3
Assumptions and Constraints
● The development cycle time frame – 60 Weeks
● The processes involved in the Software Development Life Cycle shall meet the requirements
specified by the EN IEC 62304:2019
3. Processes and Activities

Processes
Sl. No. Process Responsibility Approval Authority

1 Software Development Process

2 Software Risk Management

Process

3 Software Maintenance Process

4 Software Configuration
Management Process
5 Software problem resolution
process

Software Development Process

Software Development Life Cycle Model

The software is intended for the X-Ray Machine. The software requirements are derived from the system
requirement of the medical device.
The requirement of the software are fixed and fully established at the start of the software development
process. The Model Waterfall is used in the software development cycle.
The following activities will be carried out in the software development process and the order specified.

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Project Deliverables

Sl Activity Deliverables Document

No. Reference no.
1. Software Development Software Development Plan
Planning
2. Software Requirements Software Requirements
Analysis Specification
3. Software Architectural Software Architecture Document
Design (High-level)
4. Software Detailed Design Software Detailed Design
Document
5. Unit Implementation and Software Components, builds and
Testing Executables,
Unit test Plan, Unit
Test Cases, Unit Test
Results,
Unit Test Acceptance Criteria
6. Software Integration and Integration Plan Integration
Integration Testing Test Results
7. Software System Testing System Test Plan
System Test Results
8. Software verification List of deliverables to be verified
Milestone at which they are verified
Verification reports with criteria and
results

4. Organization Structure
The project team will consist of three members. HEAD OF ORGINIZATION, Design &
Development & QA/MR. Responsibilities of each of the members are as follows:
● HEAD OF ORGINIZATION
o Develop plans and procedures

● Design & Development

o Software Requirements Analysis
o Architecture and Detailed Design
o Unit Implementation and Testing
o Integration and Integration testing
o System Testing

● QA/MR

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 o Manage Control Activities
o Manage document generation
o Review and/or audit the development process
5. Standards
The following standards and guidelines will be used
● IMDR 2017

● ISO 14971: 2019 Medical devices - Application of risk management to

Medical Devices

● IEC 62304: 2019 Medical device software - Software life cycle processes

6. Traceability
● The Design Inputs of X-Ray Machine shall be used to derive the Software
requirements.

● First prepare a Software Requirements Specification (SRS) in order to

document the high- level software requirements from the System requirements.

● A suitable Requirements Traceability tool shall be selected.

● The tool should have the ability to track additional, lower-level requirements
throughout the entire lifecycle.

● In addition, the tool should also be able to verify that all valid requirements are
met and where in the system they are satisfied.

● Derive the high-level software requirements from the System Design Inputs
and add the requirements to the requirements traceability tool.

● As additional lower-level requirements are identified, they should also be

added to the tool.

● Finally, verify that all the requirements have been satisfied during the System Testing
7. Software Configuration and Change Management
● The Software System will be developed as independent Software Items

● Keil Micro vision 5 shall be used for managing the software items.

Keil Micro vision is an integrated development environment (IDE), which

integrates a text editor to write programs, a compiler and it will convert the
sources code to hex files too. Keil provides a broad range of development tools

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 looks like ANSI C compiler, macro assembler, debugged and simulator, IDE,
library managers, real time operating systems (RTX5) and evaluation boards.
KPC 2148is interpreted with an AVR At mega 128, the IDE that is used in
ATMEL Studio7which is renamed a microchip studio. Microchip studios
carries and integrates ATMEGA START, the MPLAB R XC8 compiler
supporting AVR device, the GCS Toolchains for both AVR and SAM Device.
Advanced software from work, AVRA assemblers and simulators

8. Software Problem Resolution

The software is delivered as part of the medical device and hence the software
problem resolution process is incorporate in the problem resolution process for the system.

Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D

X-Ray Machine Software

Safety Classification

Revision History

Rev. Change History Approvers

00 Initial Release

1. Purpose

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 The purpose of the software safety classification is to classify the software
associated with medical device as per "IEC 62304: 2019"
X-Ray Machine

Model Names

2. Reference standards
IEC 62304: 2019 Medical Device Software – Software Life cycle Processes

3. Assigning Software Safety Classification

Use below flowchart (Fig. 1) to define class of the software

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 Figure 1: Flowchart for software
classification

I. The Software System is Software System Class A if,

 A Software System failure cannot contribute to a Hazardous Situations.

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  A Software System failure can contribute to a Hazardous Situations which does not result in
unacceptable RISK after consideration of Risk control measures external to the Software
System.

II. The Software System is Software System Class B if,

 A Software System failure can contribute to a Hazardous Situations which results in

unacceptable RISK after consideration of Risk control measures external to the Software
System and cannot result in Serious Injury.

III. The Software System is Software System

Class C if,

 A Software System failure can contribute to a Hazardous Situations which results in

unacceptable RISK after consideration of Risk control measures external to the Software
System and resulting in possible SERIOUS INJURY.

Class B belongs to the X-Ray Machine.

Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D
X-Ray Machine Software Requirement Analysis

Revision History

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 SL Rev. Section Date Summary of changes
No. Changed
1 00 - 10-01-2023 Initial creation

Contents
1. Introduction...................................................................................................................................3
Purpose.......................................................................................................................................3
Definition of Terms....................................................................................................................3
References..................................................................................................................................4
2. Functional Requirements..............................................................................................................4
Performance................................................................................................................................4
Tools & Compilers.....................................................................................................................4
Computing Environment............................................................................................................4
3. Software System Inputs & Outputs..............................................................................................4
Data Characteristics...............................................................................................................4
Device Modes and Power Settings.............................................................................................4
Accessories...............................................................................................................................11
Alarms, Warnings & Operator messages.................................................................................11
4. Software Sub System..................................................................................................................12
5. Interface Between Software System and Other Systems...........................................................12
Touch Screen/LED Digital Interface...................................................................................12
Display................................................................................................................................13
Accessory Interface.............................................................................................................13
RF Generator Control..........................................................................................................13
Alarm System......................................................................................................................13
Self-Diagnostics..................................................................................................................13
6. Usability Engineering Requirements..........................................................................................13
Human Equipment Interactions...........................................................................................13
Operator Data Entry..................................................................................................................13
Display

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 Device Activation.....................................................................................................................14
7. Data Definition and Database Requirements..............................................................................14
8. Installation & Acceptance Requirements...................................................................................14
Installation Requirements....................................................................................................14
Acceptance Requirements...................................................................................................14
9. User Documentation...................................................................................................................14

10. Software Risk Control Measures for Hardware Failures........................................................14

1. Introduction
This document captures the software requirements of X-Ray Machine. X-Ray
Machine

Model Names

Purpose
This document provides specification of the software requirements for the medical device –
X-Ray Machine, also known as surgical light, are lamps that illuminate the surgical site, to
get the best view of small, low-contrast objects at different depths in the incision and body
cavity.

Definition of
Terms
Activities

A set of one or more

interrelated tasks.[EN
IEC 62304: 2019,
definition 3.1]

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 Process

A set of interrelated or interacting activities that use

inputs to deliver an Intended output.
[ISO 81001-1, definition 3.38, modified]

Software Item

Any identifiable part of a

software program. [ISO/IEC
12207:2017,
definition 3.1.53]

Software System

Integrated collection of Software Items organized to accomplish a specific function

or a set of functions.
[EN IEC 62304: 2019, definition 3.34]

System

Integrated composite consisting of one or more of the Processes, Hardware, Software,

facilities and people, that provides a capability to satisfy a stated need or objective.
[ISO 81001-1, definition 3.61, modified]

Task

A single piece of work that needs to

be done [EN IEC 62304: 2019,
definition 3.38]
References
[1] Design Inputs for X-Ray Machine.

[2] Software Development Plan for X-Ray Machine.

[3] Software Integration and Integration Testing Plan for X-Ray Machine.

[4] Software Verification Plan for X-Ray Machine.

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 [5] Software Configuration Management Plan for X-Ray Machine.

2. Functional Requirements

Performance
System Startup which includes the hardware and software integrity checks should be
performed within 10 sec. from startup

Tools & Compilers

Software will be coded using C & C++ language with ANSI C compiler for generation
of machine codes.

Computing Environment
Software will be intended for Keil µvision 5 microcontroller and will be used for
managing software items.
3. Software System Inputs & Outputs

Data Characteristics
Device Modes and Power Settings
Software shall be able to support the following device modes with the power settings,

Model -

S.N. Specification Title Allowed Values

1 Performance Mode of integrated scavenging system Passive
Parameter with pressure relief valve
Minimum Battery backup for anesthesia 2 hour
workstation
Minimum Battery backup for Ventilator 2 hour
Minimum Battery backup for monitor 2 hour
Facility of manual ventillation in case of Yes
electricity and battery failure
Facility of gas and agent delivery in case Yes
of electricity and battery failure
Air/N₂O interlock Yes
2 Gas Delivery Mode of gas mixing Pneumatic
System Type of hypoxic guard with automatic Mechnical
cutoff of N2O
3 Vaporizer Vaporizer compatible Sevoflurane, Isoflurane

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 Breathing System Volume capacity of breathing system in 1.5
liters
5 Anesthesia Available modes of operating ventilator Manual/spont, volume controlled , pressure
Ventilator controlled,SIMV/PS
Tidal Volume 20 — 1500ml
PEEP 0-20mbar
Breathing Frequency 4 to 60 BPM
I:R Ratio 4 : 1 to 1 : 4

Accessories

NA

Alarms, Warnings & Operator messages

Alarm Alarm Conditions
Treatment Time alarm  When the device is functioning and the set
treatment time is over.

Warnings:
Software shall be able to display the following messages,
 If the Power switch-on Self-test is successful, all visual indicators & displays on the
front panel will be illuminated and activation tone will be sound.
 Medical Device When the user / operator. LCD (touch) display will indicate all the
functional parameters of the device.
 Medical Device will provide user consistent performance with LED digital display of
Settings & modes.

4. Software Sub System

The Software System shall be divided into two main subsystems,

a. Master Subsystem
 The master subsystem will be running on the master microcontroller.
 It will be responsible for all the user inputs like touch screen display,
Maintaining of temperature, integrated features and accessories.
 It will also be responsible for management of the control variables of the RF generator.

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 b. Slave Subsystem
 The slave subsystem will be running on the slave microcontroller.
 It will be responsible for controlling the output from device to output ports on the
medical device

5. Interface Between Software System and Other Systems

The Software System interfaces with other components within the medical device.

Touch Screen/LED Digital Interface

Touch Screen/LED Digital interface is used to obtain inputs from user.
 Software system should interface with Touch Screen/LED Digital Display.
 Software continuous to pull for user inputs from the Touch Screen every 10µs.
 Software checks if any key has been pressed by operator and if so retrieves the code
of that key.
 Software performs all the functions associated with key press.
Display
The software is responsible for generating characters which are then displayed on the
LCD Touch Screen/LED Digital Display.
Accessory
Interface NA.

Infant Warmer Medical Device Control

The software controls the delivery of light on the infant as per the treatment time set on
the device as per the user inputs to the medical device.

Alarm System
Upon encountering any alarm condition, the software sends the appropriate signal to
the speaker to generate the alarm.

Self-Diagnostics
The software performs Power-On-Self-Checks in order to ensure that all hardware items
such as alarms, memory etc. are working properly.

6. Usability Engineering Requirements

Human Equipment Interactions

Operator Data Entry
.
 The operator should be able to set the desired Treatment Time and Output level.
 Automatic check for acceptability of the input values.
 Set Treatment time settings change during device activation should not be allowed.

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  Device mode change during device activation should not be allowed.
 The operator should be able to set following settings
 Temperature
 Heater Output
 Modes

Display
 Continuous display of the Treatment Time and Output level.
 Error display in case of errors or warnings.
 The software should be responsible for generating characters which are then displayed
on the display.
Display shall be designed in such a way that it can be readable in dim light ambient conditions also.
 Display shall be designed in such a way that Power settings being delivered
should be readable in dark.
 The Display should be splash proof.

Device Activation
 Visual indication of the mode during the device activation.
 Audio indication based on the set volume during device activation.

7. Data Definition and Database Requirements

 The current user settings shall be stored in the permanent memory (EEPROM) of the device.
 It should contain
 The last used device mode and power settings
 Accessory settings
 Timeout settings
 The setting shall be stored as an array of unsigned 8-bit integers.

8. Installation & Acceptance Requirements

Installation Requirements
The software is pre-installed and delivered as part of the medical device. Hence, the
software installation requirements are the same as the system installation requirements
and there are no additional requirements imposed on the On-Site installation of the
software.
Acceptance Requirements
The software is delivered as part of the medical device and hence the acceptance for the
software are included in the acceptance requirements of the medical device.
9. User Documentation
Following user documentation shall be developed:
 User Manual

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  Service Manual

10. Software Risk Control Measures for Hardware Failures

The medical device software shall implement self-diagnostics, which perform Power-
On-Self- Checks to reduce the risks associated with the failure of the hardware
subsystems.
Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D

X-Ray Machine
Software Architecture Design

Revision History

SL Rev. Section Date Summary of changes

No. Changed
1 00 - 14-01-2023 Initial creation

Contents
1. Introduction...................................................................................................................................3

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 Purpose.......................................................................................................................................3
Definition of Terms....................................................................................................................3
References..................................................................................................................................4
2. Architecture of the Software System............................................................................................4
Software Structure......................................................................................................................4
3. Interfaces of software items..........................................................................................................5
Interface between User interface and power generation control................................................5
Interface between User Interface and Hardware System............................................................5
Interface between Self-Diagnosis and Hardware System...........................................................5
4. SOUP Items..................................................................................................................................5

1. Introduction
This document provides an architecture design for the software system of X-
Ray Machine.
X-Ray Machine

Model Names

Purpose
The objective of the document is to conceive a high-level architecture of the
software items for the medical device – X-Ray Machine.

Definit
ion of
Terms
Activit
ies
A set of one or more
interrelated tasks.[EN
IEC 62304: 2019,
definition 3.1]

Process

A set of interrelated or interacting activities that use

inputs to deliver an Intended output.

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 [ISO 81001-1, definition 3.38, modified]

Software Item

Any identifiable part of a

software program. [ISO/IEC
12207:2017,
definition 3.1.53]

Software System

Integrated collection of Software Items organized to accomplish a specific function

or a set offunctions.
[EN IEC 62304: 2019, definition 3.34]

System

Integrated composite consisting of one or more of the Processes, Hardware,

Software, facilitiesand people, that provides a capability to satisfy a stated
need or objective.
[ISO 81001-1, definition 3.61, modified]

Task

A single piece of work that needs to be done [EN IEC 62304: 2019, definition 3.38]
References
[1] Design Inputs for X-Ray Machine.

[2] Software Requirements Specifications for X-Ray Machine.

[3] Software Integration and Integration Testing Plan for X-Ray Machine.

[4] Software Verification Plan for X-Ray Machine.

[5] Software Configuration Management Plan for X-Ray Machine.

2. Architecture of the Software System

Software Structure

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 The software included in the medical device shall provide the interface for LCD touch
screen as the alarm system of the device. It shall also serve to provide RF power
generation control and Contact Quality Monitoring.

Based on the software requirements, the following functionalities have been identified for
the software:

 Provide user interfacing through touch screen display (of X-Ray Machine MODELS).
The software shall accept inputs from the user, carry out necessary operations and
display the output in terms of final or intermediate results as well as warning and error
messages.
 Provide operator interfacing for Setting of Output Power, Color Temperature, Output
Level increment and decrement. The software shall accept inputs from the user through
the display, carry out necessary operations and display the output in terms of final or
intermediate results as well as warning and error messages on the touch screen display
itself.
 The software shall also provide self-checks, which notify the operator of any hardware
failures when the device is powered.
Thus, the Software System is divided into the following Software items:
i. User Interface
ii. Control Temperature environment
iii. Self-Diagnostics

3. Interfaces of software items

Interface between User interface and power generation control

a. For display, User/Operator selects arrow membrane button/ selector button & for LCD
touch screen user touch the arrows of the modes on the screen to set the output.
b. For display, User/Operator press Up-Down push buttons to set/change the Treatment
Time of the device. For LCD touch screen, User/operator touch the arrows of the
Treatment Time of the device.
c. The software item controls the Heat generation based on the input parameters.

Interface between User Interface and Hardware System

a. User interface monitors the various components of the hardware system and raises the
appropriate alarm in case of an error or failure.
b. In When the user / operator Changes set Output on color display. LCD display indicate
all the functional parameters of the device.

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 Interface between Self-Diagnosis and Hardware System

a. If the Power switch-on Self-test is successful, all visual indicators & displays on the
front panel illuminated and activation tone will be sound.
b. It also communicates with alarm system when it wants to raise an alarm.

4. SOUP Items
As per the definition of SOUP Item, the X-Ray Machine does not have any
SOUP items built into the device. However, the compilers, development and
testing tools all run on Windows Operating System and are treated as SOUP
items. The software risk analysis evaluates the hazards related to such items.
Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D

X-Ray Machine

Software Development Detailed Design

Revision History

SL Rev. Section Date Summary of changes

No. Changed
1 00 - 30-01-2023 Initial creation

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 Contents
1. Introduction...................................................................................................................................3
Purpose.......................................................................................................................................3
Definition of Terms....................................................................................................................3
References..................................................................................................................................4
2. Software Units..............................................................................................................................4
User Interface.............................................................................................................................4
Power delivery Control...............................................................................................................4
Self-Diagnostics..........................................................................................................................5

1. Introduction
This document provides the detailed design for the software system of X-Ray
Machine.

X-Ray Machine

Model Names

Purpose
The objective of the document is to provide detailed design for the software
system of the medical device – X-Ray Machine.

Definition of Terms

Activities
A set of one or more
interrelated tasks.[EN
IEC 62304: 2019,
definition 3.1]

Process

A set of interrelated or interacting activities that use

inputs to deliver an Intended output.
[ISO 81001-1, definition 3.38, modified]

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 Software Item

Any identifiable part of a

software program. [ISO/IEC
12207:2017,
definition 3.1.53]

Software System

Integrated collection of Software Items organized to accomplish a specific function

or a set offunctions.
[EN IEC 62304: 2019, definition 3.34]

System

Integrated composite consisting of one or more of the Processes, Hardware,

Software, facilitiesand people, that provides a capability to satisfy a stated
need or objective.
[ISO 81001-1, definition 3.61, modified]

Task

A single piece of work that needs to

be done [EN IEC 62304: 2019,
definition 3.38]
References
[1] Design Inputs for X-Ray Machine.

[2] Software Requirements Specifications for X-Ray Machine.

[3] Software Integration and Integration Testing Plan for X-Ray Machine.

[4] Software Verification Plan for X-Ray Machine.

[5] Software Configuration Management Plan for X-Ray Machine.

2. Software Units
The software items in the software are divided into the following software units
User Interface
This software item is refined into the following software units.

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 Accessories Input
NA

Display

This software unit accepts the inputs from the User from Push keys, Up-down arrows,
LED Touch Screen display (of X-Ray Machine MODELS X-Ray Machine MODELS).
The
display inputs are received through the hardware GPIO pins and the software interprets
the hardware inputs. Based on the inputs the software takes the necessary action and
updates the display as well as alerts the operator of any warnings or errors.
This software unit controls the LED & LCD touch screen display. The software displays
 Output Power Setting
 Color Temperature
 Errors and Warnings

Treatment Time Control

This software unit controls the Treatment time which result in formation of light over
the Patient by the device.

Self-Diagnostics
This software unit carries out self-checks on power up and will notify the operator of
any hardware failures when the device is powered.

Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D

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 X-Ray Machine Software
Development Unit Testing

Revision History

SL Rev. Section Date Summary of changes

No. Changed
1 00 - 06-02-2023 Initial creation

Contents
1. Introduction...................................................................................................................................3
Purpose 3
Definition of Terms.................................................................................................................................3
References...............................................................................................................................................4
2. Unit Verification...........................................................................................................................4
Verification Strategy, Methods and Procedures......................................................................................4
Black-Box Testing...................................................................................................................................4
White-Box Testing..................................................................................................................................4
Unit Test Cases........................................................................................................................................5
Alarm System 5
Safety 5
Self-Diagnostics......................................................................................................................................................5

1. Introduction
This document establishes the software unit testing and verification process of X-Ray
Machine.
X-Ray Machine

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 Model Names

Purpose
The objective is to establish strategies, methods and procedures for verifying each
software unit.

Definition of
Terms
Activities
A set of one or more
interrelated tasks.[EN
IEC 62304: 2019,
definition 3.1]

Process

A set of interrelated or interacting activities that use

inputs to deliver an Intended output.
[ISO 81001-1, definition 3.38, modified]

Software Item

Any identifiable part of a

software program. [ISO/IEC
12207:2017,
definition 3.1.53]

Software System

Integrated collection of Software Items organized to accomplish a specific function

or a set offunctions.
[EN IEC 62304: 2019, definition 3.34]

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 System

Integrated composite consisting of one or more of the Processes,

Hardware, Software, facilitiesand people, that provides a capability to
satisfy a stated need or objective.
[ISO 81001-1, definition 3.61, modified] Task

A single piece of work that needs to

be done [EN IEC 62304: 2019,
definition 3.38]
References
[1] Design Inputs for X-Ray Machine.

[2] Software Development Plan for X-Ray Machine.

[3] Software Integration and Integration Testing Plan for X-Ray Machine.

[4] Software Verification Plan for X-Ray Machine.

[5] Software Configuration Management Plan for X-Ray Machine.

2. Unit Verification

Verification Strategy, Methods and Procedures

The verification process will use both Black-Box and White-Box testing techniques.

Black-Box Testing
 Black box testing techniques will be used to ensure that the software requirements are
satisfied without looking into the internals of the code.
 All Software Units shall be tested in order to verify that they correctly
implement the requirements.
 Appropriate stubs and drivers shall be used while testing a particular function. The
stubs and driver code will also be documented and added to the configuration
management process.
 Test cases shall be derived from each software requirement and will test for the entire
input data range.
 Equivalence partitioning shall be used in order to aggregate test cases for similar
input data, thus avoiding redundant test cases.

White-Box Testing

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  The white-box testing techniques will be carried out after the black box verification
task is over.
 As the size of memory available for the code is very limited, the code should not
contain any unreachable or redundant portions that may bloat the code size. The
primary purpose of the White-Box verification task shall be to ensure that code does
not contain any of these portions.
Basis-path testing shall be used in order to ensure that all independent paths within the code are
exercised at least once.
 White-Box testing also ensures that the embedded software, which is generated by
using SOUP, has consistent structure and expected code.

Unit Test Cases

The test cases have been organized according to the software units as
follows: Please refer – Software Testing Procedure Report
The models of X-Ray Machine have been tested.

Alarm System
Results of
Test case Alarm Conditions/Input Data Expected Results Actual Results Black
Box/White
Box Testing
Treatment When the device senses a system Alarm is enabled System Pass
Time alarm condition, an alarm tone and remains in the Alarm works
Alarm sounds and the device is same state as long properly
deactivated. An alarm flashes in the as Alarm
display on the front panel. Condition is true

Safety
Results of
Actual
Test case Input Expected Results Black
Results
Data Box/White
Box Testing
Treatmen If the device senses the treatment No input detected Treatment Pass
t time time is over. by the user , and time is over.
over device is in hold
error state
Self-Diagnostics

Results of
Test case Input Data Expected Results Actual Results Black
Box/White

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 Box Testing
Memor Start-up testing Each storage location in Memory system Pass
y sequence a memory device is is working
System working, Address lines properly
and the data lines are
wired properly if not the
corresponding error
code is displayed
Master Start-up testing The data packets are Master slave Pass
Slave sequence exchanged between communication
Commu master and slave to works properly
nication ensure the proper
communication.
The corresponding error
code is displayed if there
is Communication
Failure.
Power Start-up testing Ensures the working of Power converter Pass
Convert sequence all the components section works
er related to output power properly
Section delivery is
working.
Approvals:

Prepared by:

Department Name Designation Sign

D&D

Review by:

Department Name Designation Sign

D&D

Prepared by: Approved by: Page 30 of 30