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AAMI 2800 1 1 2022

AAMI 2800 1 1 2022

$148.98

ANSI/AAMI/UL 2800-1-1:2022, Standard for Risk Concerns for Interoperable Medical Products

Published By Publication Date Number of Pages
AAMI 2022 59
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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 2800-1-1:2022; Standard for Risk Concerns for Interoperable
Medical Products
3 Title page
4 Commitment for Amendments
Copyright information
5 Contents Page
6 Committee representation
7 AAMI Standard
9 Standard for Risk Concerns for Interoperable Medical Products
1 Introduction
10 2 Scope
3 Referenced Publications
11 4 Terms and Definitions
5 Risk Concerns
5.1 General
5.2 Clinical properties
5.2.1 Semantic interoperability
12 5.2.2 Patient identity
5.2.3 Operator identity, authentication, and authorization
14 5.2.4 Interoperable item id, authentication, and authorization
15 5.3 Engineering properties
5.3.1 Interoperability item connectivity
16 5.3.2 Safe states
5.3.3 Time synchronization
17 5.3.4 Shared resources, and data/time partitioning
18 5.4 Service properties
5.5 Security properties
19 Annex A (Informative) Interoperability Usability Concepts
A1 Overview
20 A2 Recommendations
23 Annex B (Informative) Security Properties of Interoperable Medical Systems
B1 Security Elements of SSOs
24 B2 Relationship to UL 2900 Series
25 Annex C (Informative) Clinical Properties of Interoperable Medical Systems
C1 Semantic Interoperability and Nomenclature
C1.1 Overview
27 C1.2 Recommendations
C1.2.1 Interoperable item development
28 C1.2.2 Interoperable item integration
C1.2.3 Interoperable medical system development
C1.2.4 Interoperability framework
C1.2.5 Supporting concepts
29 C2 Patient Identity and Association
C2.1 Overview
C2.2 Recommendations
C2.2.1 Interoperable item development activities
31 C2.2.2 Interoperable medical system development activities
32 C3 Operator Identification, Authentication, and Authorization
C3.1 Overview
C3.2 Recommendations
C3.2.1 Interoperable item development
34 C3.2.2 Interoperable item integration
35 C3.2.3 Interoperable medical system development
38 C3.2.4 Interoperability framework
39 C4 Item Identification, Authentication, and Authorization
C4.1 Recommendations
C4.1.1 Interoperable item development activities
40 C4.1.2 Interoperable item integration activities
41 C4.1.3 Interoperable medical system development activities
44 C4.1.4 Interoperability framework activities
45 Annex D (Informative) Engineering Properties of Interoperable Medical Systems
D1 Interoperable Item Connectivity
D1.1 Overview
47 D1.2 Recommendations
D1.2.1 Interoperable item development
48 D1.2.2 Interoperable item integration
50 D2 Safe States
D2.1 Overview
D2.2 Recommendations
51 D2.2.1 Interoperable item development
D2.2.2 Interoperable item integration
D2.2.3 Interoperable medical system development
D3 Time Synchronization
D3.1 Overview
52 D3.2 Recommendations
53 D4 Shared Resources and Data and Time Partitioning
D4.1 Overview
D4.2 Recommendations
56 Annex E (Informative) Services for Interoperable Medical Systems
E1 General
E1.1 Alarm system considerations
E1.2 Management of alarm conditions in an interoperable medical system
57 E2 Alarm Signaling to Operator
E3 Alarm System Characteristics
E3.1 Logging
58 E3.2 Acknowledgment
E3.3 Quality of service
E3.4 Intelligent alarm system
E4 Intelligent alarm system
E5 Interoperable Item Capabilities
59 E6 Interoperable Medical System Maintenance and Diagnostics

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