software unit verification in iec 62304 - medconf · 2018. 11. 29. · software unit verification...
TRANSCRIPT
![Page 1: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/1.jpg)
Building a safe and secure embedded world
Frank Büchner, Hitex GmbH, Karlsruhe
Software Unit Verificationin IEC 62304
![Page 2: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/2.jpg)
Founded 1976 in Karlsruhe, Germany
Approx. 50 employees
Subsidiary in UK (20 employees)
Part of the Infineon Group since 2003
Tools for safety & security
Test services
Engineering, production, consulting
AURIX preferred design house (PDH)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 2
Hitex GmbH
![Page 3: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/3.jpg)
Inspiration by a look in non-medical standards
IEC 61508
ISO 26262
DIN EN 50128
ISO 14971
ISO 13485
IEC 60601-1
IEC 61010-1
ISO/IEC 12207
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 3
Motivation
![Page 4: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/4.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 4
Contents
![Page 5: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/5.jpg)
Software Unit Verification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 5
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 24(Copyright der VDE VERLAG GmbH)
DIN EN 62304:2018-06, p. 28(Copyright der VDE VERLAG GmbH)
![Page 6: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/6.jpg)
What is an unit?
Three criteria
1. Not subdivided / not further decomposed
2. Separately testable
3. Defined by manufacturer
Software item
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 6
A Look in 62304
![Page 7: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/7.jpg)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 7
A Look in 62304
Software Unit
U
U
U U
U
U U
Software System
Software Item
Software Items:
What is an unit?
![Page 8: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/8.jpg)
What is an unit?
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 8
Conclusion
Programming language Unit
C Function
C++, Java, C#, … Method
Ada Procedure / Function
…
Second term: verification
![Page 9: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/9.jpg)
Verification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 9
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 14
![Page 10: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/10.jpg)
Verification
Where do the requirements come from?
Includes
• Requirements Decomposition + Risk Analysis
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 10
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 23
![Page 11: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/11.jpg)
Verification
Strategies, methods, and procedures
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 11
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 24
![Page 12: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/12.jpg)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 12
Excursus
Test
dynamicstatic
manual (by human)
automated (by tool)
automated (by tool)
![Page 13: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/13.jpg)
Verification Acceptance Criteria
Software Unit Acceptance Criteria
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 13
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 19
IEC 62304:2006+AMD1:2015, 5.5.3, p. 24
![Page 14: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/14.jpg)
Requirements
Link Matrix
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 14
Discussion Acceptance Criteria
![Page 15: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/15.jpg)
Interface
Structure
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 15
Discussion Acceptance Criteria
![Page 16: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/16.jpg)
Coding standards (1/2)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 16
Discussion Acceptance Criteria
IEC 62304:2006+AMD1:2015, p. 49
![Page 17: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/17.jpg)
Coding standards (2/2)
Proprietary coding rules
Ready-made, e.g. MISRA, CERT-C
Checked by static analysis
Preferrably checked by tool
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 17
Discussion Acceptance Criteria
![Page 18: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/18.jpg)
Additional acceptance criteria
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 18
A Look in 62304
IEC 62304:2006+AMD1:2015, p. 24
![Page 19: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/19.jpg)
Proper Event Sequence
E.g. by checking the „Call Trace“
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 19
Discussion Additional Acceptance Criteria
![Page 20: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/20.jpg)
Data flow
A variable can have 3 states:
1. d: defined (= value assigned)
2. r: referenced (= value used)
3. u: undefined (= not initialized)
Three data flow anomalies:
1. ur
2. du
3. dd
A data flow anomaly does not need to result in a failure
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 20
Discussion Additional Acceptance Criteria
![Page 21: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/21.jpg)
Control flow
Example: Unreachable code
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 21
Discussion Additional Acceptance Criteria
![Page 22: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/22.jpg)
Fault handling
Needs requirement
Initialization of variables
This is a data flow anomaly
Self-diagnostic
Needs requirement
Boundary conditions
Relates to test case specification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 22
Discussion Additional Acceptance Criteria
[ [
![Page 23: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/23.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 23
Contents
![Page 24: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/24.jpg)
62304 mentions
Coverage of requirements
But not code coverage for unit verification
Code coverage in ISO 26262:2011 for Unit Testing
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 24
26262 and Code Coverage
Part 6, Table 12
![Page 25: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/25.jpg)
Recommendation
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 25
26262 and Code Coverage
Safety Class 62304 Coverage Measure
A Statement Coverage
B Branch Coverage
C Modified Condition / Decision Coverage (MC/DC)
![Page 26: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/26.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 26
Inhalt
![Page 27: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/27.jpg)
62304
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 27
50128 and Independent Testing
IEC 62304:2006+AMD1:2015, p. 8
IEC 62304:2006+AMD1:2015, p. 64
![Page 28: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/28.jpg)
50128 – Bahnanwendungen / Railway
At SIL 0: A person, who is … implementer of a software component must not be tester … of the same software component.
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 28
50128 and Independent Testing
DIN EN 50128:2012-03(Copyright der VDE VERLAG GmbH)
(translation by the author)
![Page 29: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/29.jpg)
Why is independent testing important? (1/3)
Example of a specification
A start value and a length define a range of values. Determine if a given value is within the defined range or not. The end of the range shall not be inside the range. Only integer numbers are to be considered.
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 29
Independent Testing
value
startlength
[ [
outside outsideinside
![Page 30: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/30.jpg)
Why is independent testing important? (2/3)
This case is simple
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 30
Independent Testing
Value = 6 inside!
Start = 5Length= 2
[ [5 6 7
![Page 31: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/31.jpg)
Why is independent testing important? (3/3)
But this case?
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 31
Independent Testing
Value = -6 ???
Start = -5
] ]-7 -6 -5
Length= -2
![Page 32: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/32.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 32
Contents
![Page 33: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/33.jpg)
IEC 61508
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 33
61508 and Software Complexity Control
IEC 61508-3:2010, Table B.9
![Page 34: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/34.jpg)
Metrics for software complexity control
Examples
• Cyclomatic complexity according to McCABE
• Volume according to Halstaed
Tool support necessary!
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 34
61508 and Software Complexity Control
![Page 35: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/35.jpg)
Software module size limit
61508-7, section C.2.9: „typically 2 to 4 screen sizes“
Metric Lines-of-code (LOC)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 35
61508 and Software Complexity Control
![Page 36: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/36.jpg)
Parameter number limit
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 36
61508 and Software Complexity Control
![Page 37: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/37.jpg)
One entry / one exit
Rule 15.5 from MISRA-C:2012
• Only one return statement at the end
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 37
61508 and Software Complexity Control
![Page 38: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/38.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 38
Contents
![Page 39: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/39.jpg)
How to find test cases for black-box unit tests?
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 39
26262 and Test Case Specification
ISO 26262:2011, part 6, table 11
![Page 40: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/40.jpg)
Methods from ISO 26262 for deriving test cases
Equivalence classes
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 40
26262 and Test Case Specification
![Page 41: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/41.jpg)
Test case specification using the Classification Tree Method
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 41
Excursus
![Page 42: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/42.jpg)
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 42
26262 and Test Case Specification
Methods from ISO 26262 for deriving test cases
Error guessing
aka “intuitive testing”
aka “experienced-based testing”
![Page 43: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/43.jpg)
1. A Look in 62304
2. A Look in Other Standards
2.1 26262 and Code Coverage
2.2 50128 and Independent Testing
2.3 61508 and Software Complexity Control
2.4 26262 and Test Case Specification
2.5 26262 and Tool Qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 43
Contents
![Page 44: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/44.jpg)
Methods for tool qualification
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 44
26262 and Tool Qualification
ISO 26262:2011, part 8, table 4
![Page 45: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/45.jpg)
Any questions?
Unit test tool TESSY by Razorcat
www.hitex.de/tessy
Static analysis tool KLOCWORK by Roguewave
www.hitex.de/klocwork
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 45
Thank you for listening!
![Page 46: Software Unit Verification in IEC 62304 - MedConf · 2018. 11. 29. · Software Unit Verification in IEC 62304 Founded 1976 in Karlsruhe, Germany Approx. 50 employees Subsidiary in](https://reader036.vdocuments.site/reader036/viewer/2022081523/5fd4f79112988d0637390bef/html5/thumbnails/46.jpg)
Frank BüchnerDipl.-Inform.Principal Engineer Software Quality
Hitex GmbHGreschbachstr. 12KarlsruheGermany
Tel.: +49 / 721 / 9628 – 125frank.buechner(at)hitex.de
Software Unit Verification, Frank Büchner, Nov. 2018 Copyright © Hitex GmbH 2018. All rights reserved. 46
Contact & Additional Information