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Software Test Plan

for
<Project name>
Version <X.X>

Prepared by <X.X>

Approved by <X.X>

<Doc. No. : xxxx-xxx-xx>

<date created>
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Revision History
Date Rev. Description Prepared by Approved by
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TABLE OF CONTENTS
1 Introduction 2
1.1 Document overview 2
1.2 Abbreviations and Glossary 2
1.2.1 Abbreviations 2
1.2.2 Glossary 2
1.3 References 2
1.3.1 Project References 2
1.3.2 Standard and regulatory References 2
1.4 Conventions 2
2 Test environment 3
2.1 Integration and factory test site 3
2.1.1 Hardware test Platform 3
2.1.2 Software test tools 3
2.1.3 Test Data and documentation 4
2.1.4 Other test materials 4
2.1.5 Installation, set-up, and maintenance 4
2.1.6 Personnel 4
2.2 Customer/ Field test site 4
3 Tests identification 5
3.1 Testing phases 5
3.2 Test categories 5
3.3 Test progression 5
3.4 Test coverage 5
3.5 Data recording, post-processing, and analysis 6
3.6 Test identification and content 6
4 Planned tests 7
4.1 Tests Phase xxx 7
4.1.1 Tests coverage 7
4.1.2 Planned tests 7
4.2 Tests Phase yyy 7
4.2.1 Tests coverage 7
4.2.2 Planned tests 7
5 Tests schedules 8
6 Requirements traceability 9
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1 Introduction

1.1 Document overview

說明此文件的目的
Example : This document is the software test plan of the XXX software development project.

1.2 Abbreviations and Glossary

1.2.1 Abbreviations
請加上文件中有使用到的縮寫

1.2.2 Glossary
請加上文件中所使用到詞彙

1.3 References

1.3.1 Project References

# Document Identifier Document Title

[R1] 文件 ID 加上參考文件標題

1.3.2 Standard and regulatory References

# Document Identifier Document Title

[STD1] 標準 ID 加上參考的標準
增加參考的標準，可能包括 ISO14971，ISO 13485，IEC60601，IEC62304…等
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2 Test environment
請於下列章節描述測試的硬體環境及軟體測試工具

2.1 Hardware test Platform

請描述在進行軟體測試時所使用的硬體平台
• 假如使用的是一般 PC，請描述以下資訊
o CPU 處理器
o Memory
o Hard disk
o Other…
• 假如使用特別的硬體(例如硬體模擬器…等)，請描述以下資訊
o 目的
o 名稱
o 製造商
o 版本及序號
o 韌體版本
o Anything else …

2.2 Software test tools

請描述所使用的軟體工具
o 名稱
o 製造商
o 版本及序號
o Anything else …

2.3 Installation, set-up, and maintenance

請描述如何建置或是安裝測試平台

2.4 Personnel
請描述進行測試的人員資格為何? 至少需要幾位測試人員，其人員必須具備什麼樣的技能，在
這邊還不需要詳細描述是誰
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3 Tests identification

3.1 Testing phases

測試計畫主要是根據所有的需求規格定義出所有的測試步驟，其主要的 phase 根據 class 等級不
同可能包括 :
• Software unit tests (for class B, C)
• Software Integration tests (for class B, C)
• Software system tests (for class A, B, C)
• Other…

註：若軟體等級為 class A 的話，在 IEC 62304 的規範中不需要做任何測試，但 IEC 62304 是包

含在 IEC 60601 clause 14 中，所以最終還是會根據 IEC 60601 規範進行最終 Validation，所以建
議還是需要在此訂定 test plan。

3.2 Testing descriptions

請在此處根據 test phase 列出並詳細說明你要如何進行測試

3.2.1 Software unit tests

請在此處根據所訂定出的規格設計測試方法，每個規格可能有多個測試方法來進行驗證，但至
少必須一定要有一個測試方法

Test ID T-SRS-REQ-001-XX Description

Test description Verify that the xxx software
receives data from yyy
Verified SRS-REQ-001
Requirement
Initial The state of software before test You may reference a procedure or it
conditions Ex : XXX Software is started may be the result of previous test
YYY simulator is started
Tests inputs Input data from any test tool, input You may reference a procedure to
files name and location use the test tool
Data collection Recording and post processing of You may reference a procedure to
actions output data record data with a test tool
Tests outputs Output data files names and Give unique name out output data
location, logs … files.
Assumptions If any, may be limited access to a
and constraints tool, license …
Ex : YYY simulator work only in the
range of zzz
Expected results List here the results of test
and criteria
Test procedure
Step number Operator actions Expected result and evaluation
criteria
1 Send data with YYY simulator Simulator displays msg “data sent”
2 Open xxx window of xxx software Sent data are displayed, with date-
time of reception
3 Press run button Sent data are processed, result is
displayed.
Value of result is …
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3.2.2 Software integration tests

同 3.2.1

3.2.3 Software system tests

同 3.2.1