AAMI 2800 1 3 2022

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ANSI/AAMI/UL 2800-1-3:2022, Standard for Interoperable Item Integration Life Cycle

Published By	Publication Date	Number of Pages
AAMI	2022

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Category: AAMI

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Description

Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.

PDF Catalog

PDF Pages	PDF Title
1	ANSI/AAMI/UL 2800-1-3:2022; Standard for Interoperable Item Integration Life Cycle
3	Title page
4	Commitment for Amendments Copyright information
5	Contents Page
6	Committee representation
7	AAMI Standard
9	Standard for Interoperable Item Integration Life Cycle 1 Introduction
10	2 Scope 3 Referenced Publications
11	4 Terms and Definitions 5 Interoperable Item Integration Life-Cycle Activities 5.1 Architecture and interoperable item integration concept development 5.1.1 Item interoperability architecture and domain asset instantiation
12	Figure 5.1 Interoperable Environment Ontology 5.1.2 Interoperable item internal interoperability management
13	5.1.3 Internal item interoperable interactions (use cases) 5.1.4 Interoperable item preliminary hazard analysis – interoperability-related hazard analysis
14	5.1.5 Refinement of interoperable item SSOs and development of functional safety concept 5.2 Internal architecture and integration specification 5.2.1 Development of internal interoperability architecture and interface specification
15	5.2.2 Development of internal interoperability requirements
16	5.2.3 Item architecture analysis and risk management activities 5.2.3.1 Data/control flow analysis 5.2.3.2 Fault and error propagation specification 5.2.3.2.1 Normalization of fault/error categorization 5.2.3.2.2 Analysis and reconciliation of interface error behavior at binding points
17	5.2.3.2.3 Mapping of interoperable item error propagation specification to constituent interoperable items in the internal interoperability architecture 5.2.3.3 Control loop analysis
18	5.2.3.4 Realization of the functional safety concept within architecture 5.3 Constituent interoperable item development
19	5.4 Interoperable item integration 5.4.1 Planning of release criteria for interoperable item integration 5.4.2 Initiation of interoperable item integration verification planning 5.5 Interoperability file information
21	Annex A (Informative) Architecture Definition Guidance A1 Overview
22	A2 Topological Vocabulary Overview Figure A1 Entity/Relation Diagram
24	Figure A2 Concepts Related to Variability Within an Interoperable Architecture
25	A3 Examples A3.1 Interoperable item
26	A3.2 Interoperable medical system
28	A3.3 Interoperability framework
29	A4 Summary of Architectural Viewpoints
31	A5 Guidance on Use of Architecture Modeling Notations
32	Annex B (Informative) Interoperability Architecture Specification B1 Interoperability Viewpoint Guidance B1.1 General guidance on interoperability view specification B1.2 External interoperability – Specifying relationships between the product and its context B1.3 Internal interoperability – Specifying the product’s constituent interoperable item and their interoperability relationships
33	B2 Computational, Engineering, and Technology Viewpoint Guidance B2.1 General B2.2 Computational view – Computational objects B2.3 Computational view – Interoperability interfaces
34	B2.4 Guidance on decomposing interoperability view interoperability interaction points into computational view interfaces and interactions B2.5 Interaction specifications B2.6 Behavioral descriptions
35	B2.7 Engineering view – Node structure B2.8 Engineering view – Channel structure B3 Interactions with External Systems