This Technical Report gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This Technical Report applies to the transmission of alarm conditions between sources, integrator and receivers where at least one source is a medical device and at least one communication path utilizes a medical IT-network. It provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety, effectiveness and data and systems security.

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PDF Pages	PDF Title
1	ANSI/AAMI/IEC TIR80001-2-5:2014, Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems
3	Title page
4	Copyright information
5	AAMI Technical Information Report ANSI Technical Report
6	Contents
7	Glossary of equivalent standards
8	Committee representation
9	Background of AAMI adoption of IEC TR 80001-2-5
10	Foreword
11	Introduction
13	1 Scope
15	2 Normative references 3 Terms and definitions
23	4 Functions of the distribution of alarm conditions 4.1 General 4.2 Sources and their alarm conditions
24	4.3 Integrator 4.4 Communicator 4.5 Medical IT-network
25	5 Types of systems for distributing alarm conditions 5.1 General Table 1 – General comparison of system properties for ALARM CONDITION integration 5.2 Distributed information system about alarm conditions
26	5.3 Distributed alarm system 5.4 Distributed alarm system with operator confirmation 6 Risk management 6.1 General explanation
27	6.2 Determining the responsible organization’s objective purpose 6.3 Hazards and hazardous situations related to dis, das and cdas
28	6.4 Causes and resulting hazardous situations
30	6.5 Risk control measures related to the integration of alarm conditions 6.5.1 Technical risk control measures implemented in equipment
31	6.5.2 Typical risk control measures for implementation by the responsible organization
33	6.5.3 Organizational policies and procedures as risk control measures for implementation by the responsible organization
35	Annex A: Correspondence between the risk control measures of this technical report and IEC 60601-1-8 Table A.1 – Correspondence of the technical RISK CONTROL measures of this technical report for a CDAS and IEC 60601-1-8 for a DAS
37	Annex B: Types of sources B.1 Medical devices
38	B.2 Nurse call system
40	Annex C: Applicability of types of system for the distribution of alarm conditions Figure C.1 – Cascading structure of system for the distribution of ALARM CONDITIONS
41	Figure C.2 – Example for INTEGRATOR of a PATIENT monitor with central monitoring station to distribute ALARM CONDITIONS in a physically isolated IT-NETWORK in a CDAS
42	Figure C.3 – Example for INTEGRATOR of a PATIENT monitor to distribute ALARM CONDITIONS in a NURSE CALL SYSTEM, and via a PBX with handsets
43	Annex D: Scalability of types of system for the distribution of alarm conditions
44	Figure D.1 – Example hospital-wide DISTRIBUTED ALARM SYSTEM
45	Bibliography
46	Index of defined terms used in this technical report

Published By	Publication Date	Number of Pages
AAMI	2014	47


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Standard Title	AAMI/IEC TIR80001-2-5:2014 – Application of risk management for IT-networks incorporating medical devices-Part 2-5: Application guidance – Guidance for distributed alarm systems
Published Code	AAMI
Publication Date	2014
Pages Count	47

AAMI TIR80001 2 5 2014

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