UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

AAMI SW91

Classification of defects in health software

active, Most Current
Buy Now
Organization: AAMI
Publication Date: 1 January 2018
Status: active
Page Count: 76
scope:

This document identifies a defect classification system, or taxonomy, that can be used to classify the types of defects that might exist in software. The taxonomy applies to defect root causes in all types of software (including third-party software, medical device software, test software, and manufacturing software) throughout the software development lifecycle.

The classification system is meant to be neutral with respect to

• programming language,

• methodology,

• product,

• intended use,

• risk (the consequences of failure), and

• regulatory status.

The use of a common taxonomy allows industry-wide aggregation of defect occurrence data that can be used to improve software quality. Some examples of ways in which this may be accomplished are presented as use cases in Annex A.

The way in which the standard is to be used is not prescribed. The taxonomy does not attempt to classify the severity of defects, as the consequences of any defect can only be evaluated within the context of the software's intended use. It does not attempt to describe methodologies for analyzing root cause, managing defect resolution, or assigning risk. It does not attempt to categorize defects in quality system processes.

Several annexes are included for information. Annexes B, C, and D are provided to illustrate how the taxonomy can be used to categorize various types of software problems. Annex E provides examples of cause analysis using the taxonomy. Annex F provides a reference table of all defect categories and codes, and Annex G provides the rationale for the types of defects that are in scope for the standard.

 

Document History

AAMI SW91
January 1, 2018
Classification of defects in health software
This document identifies a defect classification system, or taxonomy, that can be used to classify the types of defects that might exist in software. The taxonomy applies to defect root causes in all...

References

Advertisement