AAMI規格 AAMI TIR66, 2017/(R)2020: Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms, 警報システムアルゴリズムの安全性と有効性の合理的な保証を実証するための生理学的データと波形データベースの作成手引き
Description
This document is intended to define the nomenclature, ingredients, and principles for the development, annotation and use of physiologic waveform databases for developing and testing the performance of INTELLIGENT ALARM SYSTEM algorithms, and to test ALARM SYSTEMS incorporating such algorithms. This document also identifies issues that should be addressed in the design and development of these physiologic databases. It discusses many major pitfalls that should be avoided. Annexes that describe several publicly available databases in detail are included. The database profiles that are presented here are intended to serve as a guide in the design, development, acquisition and documentation of future physiologic databases that can be used in the development and evaluation of ALARM SYSTEMS and algorithms.
This document does not cover the use of databases beyond algorithm development and performance testing to ensure delivery of the stated ESSENTIAL PERFORMANCE.
NOTE It is expected that inter-device data fusion will be covered in interoperability standards being jointly developed by AAMI and Underwriters Laboratory (UL).