AAMI 80001 1 2010

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ANSI/AAMI/IEC 80001-1:2010 – Application of risk management for IT Networks incorporating medical devices – Part 1: Roles, responsibilities and activities

Published By	Publication Date	Number of Pages
AAMI	2010	52

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Description

This standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness, and data and system security

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PDF Pages	PDF Title
1	ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices — Part 1: Roles, responsibilities and activities
2	Objectives and uses of AAMI standards and recommended practices
3	Title page
4	AAMI Standard Copyright information
5	Contents
7	Glossary of equivalent standards
9	Committee representation
10	Background of ANSI/AAMI adoption of IEC 80001-1:2010
11	FOREWORD
13	INTRODUCTION
17	1 Scope
18	2 Terms and definitions
23	3 Roles and responsibilities 3.1 General 3.2 RESPONSIBLE ORGANIZATION 3.3 Top management responsibilities
25	3.4 MEDICAL IT-NETWORK RISK MANAGER
26	3.5 Medical device manufacturer(s)
27	3.6 Providers of other information technology
28	4 Life cycle risk management in medical IT-networks 4.1 Overview
30	4.2 RESPONSIBLE ORGANIZATION RISK MANAGEMENT 4.2.1 Policy for risk management for incorporating medical devices 4.2.2 RISK MANAGEMENT PROCESS 4.3 Medical IT-network risk management planning and documentation 4.3.1 Overview
31	4.3.2 Risk-relevant asset description 4.3.3 Medical IT-network documentation
32	4.3.4 RESPONSIBILITY AGREEMENT
33	4.3.5 Risk management plan for the medical IT-network 4.4 MEDICAL IT-NETWORK RISK MANAGEMENT 4.4.1 Overview
34	4.4.2 RISK ANALYSIS 4.4.3 RISK EVALUATION 4.4.4 RISK CONTROL 4.4.4.1 Risk control option analysis
35	4.4.4.2 risk control measures 4.4.4.3 Implementation of risk control measures
36	4.4.4.4 Verification of risk control measures 4.4.4.5 New risks arising from risk control 4.4.5 Residual risk evaluation and reporting
37	4.5 Change-release management and configuration management 4.5.1 CHANGE-RELEASE MANAGEMENT PROCESS 4.5.2 Decision on how to apply risk management 4.5.2.1 Overview 4.5.2.2 CHANGE PERMITS
38	4.5.2.3 Medical IT-network projects 4.5.3 Go-live
39	4.6 Live network risk management 4.6.1 Monitoring 4.6.2 EVENT MANAGEMENT
40	5 Document control 5.1 Document control procedure 5.2 MEDICAL IT-NETWORK RISK MANAGEMENT FILE
41	Annex A Rationale A.1 General A.2 Clause 3 – Roles and responsibilities
42	A.3 Clause 4 – Life cycle RISK MANAGEMENT in MEDICAL IT-NETWORKS
43	Subclause 4.2 – RESPONSIBLE ORGANIZATION RISK MANAGEMENT Subclause 4.3 – MEDICAL IT-NETWORK RISK MANAGEMENT planning and documentation Subclause 4.5 – CHANGE-RELEASE MANAGEMENT and CONFIGURATION MANAGEMENT
44	Subclause 4.6 – Live Network RISK MANAGEMENT
45	Annex B Overview of RISK MANAGEMENT relationships
46	Annex C Guidance on field of application C.1 Overview C.2 When to apply this standard
48	Annex D Relationship with ISO/IEC 20000-2:2005, Information technology – Service management – Part 2: Code of practice D.1 General D.2 Terminology and definitions
52	Bibliography

Additional information

Standard Title	ANSI/AAMI/IEC 80001-1:2010 – Application of risk management for IT Networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published Code	AAMI
Publication Date	2010
Pages Count	52

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AAMI 80001 1 2010

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