AAMI 2800 1 2022

$172.66

ANSI/AAMI/UL 2800-1:2022, Standard for Medical Device Interoperability

Published By	Publication Date	Number of Pages
AAMI	2022	72

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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 2800-1:2022; Standard for Medical Device Interoperability
3	Title page
4	Commitment for Amendments Copyright information
5	Contents
6	Committee representation
7	AAMI Standard
9	Standard for Safety for Medical Device Interoperability 1 Introduction
10	2 Scope 3 References
11	4 Terms and Definitions
24	5 (Leadership) Management Responsibility
25	6 Interoperability Information
27	7 Interoperability Management
30	8 Interoperability Realization Processes
32	9 Design, Development, and Implementation of Interoperability
41	10 Interoperability of Externally Sourced Products
42	11 Provisioning, Deployment, and Operation
44	12 Testing and Review
46	13 Traceability and Release
47	14 Interoperability Performance Monitoring and Control of Changes
50	Annex A (Informative) Stakeholder Activities
57	Annex B (Informative) Guidance on Declaration of Products and Services
63	Annex C (Informative) Clinical Context Concepts
67	Annex D (Informative) Risk Management Guidance