AAMI 2800 1 2 2022

$139.74

ANSI/AAMI/UL 2800-1-2:2022, Standard for Interoperable Item Development Life Cycle

Published By	Publication Date	Number of Pages
AAMI	2022	48

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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 2800-1-2:2022; Standard for Interoperable Item Development Life Cycle
3	Title page
4	Commitment for Amendments Copyright information
5	Contents
6	Committee representation
7	AAMI Standard
9	Standard for Interoperable Item Development Life Cycle 1 Introduction
10	2 Scope 3 Referenced Publications
11	4 Terms and Definitions 5 Interoperable Item Development Life-Cycle Activities 5.1 Interoperable item concept and context of use development 5.1.1 Interoperable item synopsis and scope
12	Figure 5.1 Interoperable Environment Ontology 5.1.2 Interoperable item operational context of use description
13	5.1.3 Interoperable item development context of use description 5.1.4 Identification of interoperable item medical and SSOs 5.1.5 Specification of interoperable item-context interactions
14	5.1.6 Interoperable item risk analysis 5.1.6.1 Identify potential sources of harm
15	5.1.6.2 Identify potential hazards from control actions and data outputs 5.1.6.3 Preliminary hazard analysis – interoperable item functional hazard analysis
16	5.1.7 Interoperability file information 5.2 Development of item requirements and external interoperability specifications 5.2.1 Specification of item boundary 5.2.2 Development of interoperable item requirements
17	5.2.3 Interoperable item level analysis and risk management activities 5.2.3.1 Data/Control flow analysis
18	5.2.3.2 Fault and error propagation specification and analysis 5.2.3.3 Control loop analysis
19	5.2.4 Planning of release criteria for interoperable item realization 5.2.5 Initiation of interoperable item verification planning
20	5.2.6 Initiation of interoperable item validation planning 5.2.7 Interoperable item operating procedures, labeling, and disclosures planning
21	5.2.8 Interoperability file information 5.3 Interoperable item realization 5.3.1 Requirements for implementing interoperability-related functionality 5.3.1.1 Alignment of implementation with architectural and interface specifications
22	5.3.2 Implementation of interoperable item without internal interoperability 5.3.2.1 General 5.3.2.2 Realization of the safety concept 5.3.2.3 Risk management activities 5.3.3 Implementation of interoperable item with internal interoperability
23	5.4 Interoperable item assurance 5.4.1 Interoperable item verification 5.4.2 Interoperable item validation
24	5.4.3 Interoperable item release criteria substantiation 5.4.4 Interoperability file information
25	Annex A (Informative) Guidance on Interoperability File A1 Background A2 Example Work Products
26	Table A1.1 Work Products
42	Annex B (Informative) Guidance on Disclosure B1 Background B2 Key Disclosures
43	B3 Example Disclosure Content Table B3.1 Disclosures
45	Annex C (Informative) Guidance on Release Criteria C1 General C1.1 Interoperable item development activity release criteria C1.1.1 Interoperable item specification release criteria
46	C1.1.2 Interoperable item realization release criteria
47	C1.1.3 Interoperable item assurance release criteria C1.1.4 Interoperable item external measures release criteria C1.2 Interoperable item integration activity release criteria C1.2.1 Interoperable item integration specification release criteria
48	C1.2.2 Interoperable item integration assurance release criteria C1.3 Interoperable medical system release criteria C1.3.1 Interoperable medical system specification release criteria C1.3.2 Interoperable medical system realization release criteria C1.3.3 Interoperable medical system assurance release criteria