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eLibrary > ANSI/AAMI/UL 2800-1:2019 - Standard for Safety for Medical Device Interoperability >

ANSI/AAMI/UL 2800-1:2019 - Standard for Safety for Medical Device Interoperability, 2019

ANSI/AAMI/UL 2800-1:2019; Standard for Safety for Medical Device Interoperability
Objectives and uses of AAMI standards and recommended practices
Title page
Commitment for Amendments
Copyright information
Contents
Committee representation
AAMI Standard
1 Introduction
2 Scope
3 References
4 Terms and Definitions
5 (Leadership) Management Responsibility
6 Interoperability Information
7 Interoperability Management [Go to Page]
Figure 7.1 INTEROPERABLE ENVIRONMENT ontology
Figure 7.2 Schematic of interoperability realization lifecycle
8 Interoperability Realization Processes
9 Design, Development and Implementation of Interoperability [Go to Page]
Figure 9.1 Interoperability contexts of use
10 Interoperability of EXTERNALLY SOURCED PRODUCTS
11 Provisioning, Deployment, and Operation
12 Testing and Review
13 Traceability and Release
14 Interoperability Performance Monitoring and Control of Changes
15 Improvement of Processes
Annex A (Informative) Stakeholder Activities
Annex B (Informative) Guidance on Declaration of Products and Services [Go to Page]
Figure B1.1 Elements of interoperability ecosystem and key processes
Figure B1.2 Primary compliance relationships
Figure B1.3 Compliance relationships for primary topology categories
Annex C (Informative) Guidance on INTEROPERABILITY FILE [Go to Page]
Table C1.1Work products
Annex D (Informative) Guidance on DISCLOSURE [Go to Page]
Table D1.1 Disclosures
Annex E (Normative) Interoperability Realization Life-cycle ProcessE1
Annex F (Informative) GUIDANCE ON RELEASE CRITERIA
Annex G (Informative) Testing Guidance
Annex H (Informative) RISK MANAGEMENT Guidance
Annex I (Informative) Common Fault Types
Annex J (Informative) Interoperability Usability Concepts
Annex K (Informative) SECURITY Principles
Annex L (Informative) Clinical Context Concepts
Annex M (Informative) Clinical Properties of INTEROPERABLE MEDICAL SYSTEMS
Annex N (Informative) Architecture Definition Guidance [Go to Page]
Figure N1 Entity/relation diagram capturing the relationships between interoperable item, interoperablemedical system, item interoperability specification, interaction point, interoperable item boundary,and interoperability interface
Figure N2 Diagram capturing the relationships between interoperability architecture, variability,interoperability architecture configuration, and interoperability architecture instance
Annex P (Informative) Engineering Properties of INTEROPERABLE MEDICAL SYSTEMS
Annex Q (Informative) Services for INTEROPERABLE MEDICAL SYSTEMS
Annex O (Informative) INTEROPERABILITY ARCHITECTURE SPECIFICATION [Go to Page]

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