YY/T 1833.1-2022 Artificial intelligence medical device - Quality requirements and evaluation - Part 1: Terminology
1 Scope
This document defines the terms and definitions used for the quality requirements and evaluation of artificial intelligence medical devices.
This document is applicable to artificial intelligence medical devices.
2 Normative references
No normative reference is listed in this document.
3 Terms and definitions
3.1 Basic technical terms
3.1.1
artificial intelligence; AI
ability of functional units that exhibit various functions related to human intelligence (such as inference and learning)
[Source: GB/T 5271.28-2001, 28.01.02]
3.1.2
artificial intelligence medical device; AIMD
medical device that uses AI technology to realize their intended use
Note 1: For example, independent software that uses machine learning, pattern recognition, rule inference and other technologies to realize its medical use.
Note 2: Medical devices that use embedded AI algorithm and AI chip to realize their medical use.
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3.1.3
medical device software
developed software system integrated into a medical device under development, or software system intended to be used as a medical device
Note: Medical device software includes software components and independent software, where software components refer to software embedded in a medical device or used as a part of the medical device, and independent software refers to software that has one or more medical purposes, can complete its expected purpose without medical device hardware, and runs on a general computing platform.
[Source: YY/T 0664-2020, 3.11]
3.1.4
pattern recognition
recognition of physical or abstract patterns, structure and configuration of an object through functional units
[Source: GB/T 5271.28-2001, 28.01.13]
3.1.5
artificial neural network; ANN
network of basic processing elements connected by weighted links with adjustable weights, which generates a value for each unit by applying a non-linear function to its input value and transmits it to other units or expresses it as an output value
Note: Also referred to as neural network.
[Source: GB/T 5271.34-2006, 34.01.06]
3.1.6
inference
method for deriving a conclusion from a known premise
Note 1: In the field of AI, the premise is a fact or a rule.
Note 2: The term "inference" refers to both process and result.
[Source: GB/T 5271.28-2001, 28.03.01, modified]
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3.1.7
feature
measurable attribute that can express the essential functional or structural characteristics of a pattern
Note: Such as size, texture, shape, etc. A good feature can cluster similar patterns and separate different patterns.
Foreword i
Introduction i
1 Scope
2 Normative references
3 Terms and definitions
3.1 Basic technical terms
3.2 Data set terms
3.3 Quality characteristic terms
3.4 Quality evaluation terms
3.5 Application scenario terms
Annex A (Informative) Explanation of calculation equations for the evaluation indexes
Bibliography
Index
