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AAMI 2800-1

Standard for Safety for Medical Device Interoperability

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Organization: AAMI
Publication Date: 1 January 2019
Status: active
Page Count: 180
scope:

This Standard is applicable to INTEROPERABLE MEDICAL PRODUCTS, including assembled systems of INTEROPERABLE MEDICAL PRODUCTS that comprise or are intended to be incorporated into INTEROPERABLE MEDICAL SYSTEMS within an INTEROPERABLE ENVIRONMENT.

This Standard specifies a baseline set of requirements for assuring safe and secure interoperability for INTEROPERABLE MEDICAL SYSTEMS.

 

Document History

2800-1
January 1, 2022
Standard for Medical Device Interoperability
This Standard is applicable to interoperable medical products, including assembled systems of interoperable medical products that comprise or are intended to be incorporated into interoperable...
AAMI 2800-1
January 1, 2019
Standard for Safety for Medical Device Interoperability
This Standard is applicable to INTEROPERABLE MEDICAL PRODUCTS, including assembled systems of INTEROPERABLE MEDICAL PRODUCTS that comprise or are intended to be incorporated into INTEROPERABLE...

References

This document references:
AAMI TIR57 - Technical Information Report: Principles for medical device security—Risk management
Published by AAMI on January 1, 2016
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971. This guidance is intended to assist manufacturers and other users...
This document references:
ASTM F2761 - Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
Published by ASTM on January 1, 2009
This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the...
This document references:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document references:
IEC 60601-1-8 - Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Published by IEC on July 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
IEC 62304 - Medical device software – Software life cycle processes
Published by IEC on June 1, 2015
Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 26262-1 - Road vehicles - Functional safety - Part 1: Vocabulary
Published by ISO on December 1, 2018
This document is intended to be applied to safety-related systems that include one or more electrical and/or electronic (E/E) systems and that are installed in series production road vehicles,...
This document references:
ISO/IEC/IEEE 15026-3 - Systems and software engineering — Systems and software assurance — Part 3: System integrity levels
Published by ISO on October 1, 2023
This document specifies the concept of integrity levels with the corresponding integrity level requirements for achieving the integrity levels. Requirements and recommended methods are provided for...
This document references:
ISO/IEC/IEEE 42010 - Software, systems and enterprise — Architecture description
Published by ISO on November 1, 2022
This document specifies requirements for the structure and expression of an architecture description (AD) for various entities, including software, systems, enterprises, systems of systems, families...
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