AAMI規格 AAMI TIR75, 2019: Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples, マルチベンダーデバイスが電子インターフェースを介して相互作用するときに考慮すべき要素: 実用化と例
Description
General
This document is intended to assist stakeholders in considering risks associated with connectivity when designing, testing, installing, and maintaining devices that interact via an electronic interface. It identifies specific factors that should be considered as part of risk management activities. It also provides examples where these factors are used to identify causes, hazards, and hazardous situations related to interoperability. These factors can be relevant throughout the lifecycle of connected products.
This list of factors is not intended to be comprehensive. Instead, it is meant to direct design teams to think about common elements requiring dedicated attention when assessing the risk of the connected functionality of the medical device. These elements are referred to as, “Factors to Consider.”
This TIR applies to the following:
- devices with added or modified connectivity; and
- newly developed devices that are intended to connect via an electronic interface for the purposes of interoperability.
Exclusions
This TIR does not specifically consider the following:
- devices not connected by an electronic interface; and
- basic issues of medical device safety not directly related to data interoperability, e.g., electrical safety.