AAMI/IEC TIR80001-2-5:2014
Current
The latest, up-to-date edition.
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
Hardcopy , PDF
English
24-12-2014
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC TR 80001-2-5
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Functions of the distribution of ALARM CONDITIONS
5 Types of systems for distributing ALARM CONDITIONS
6 RISK MANAGEMENT
Annex A (informative) - Correspondence between the
RISK CONTROL measures of this technical report
and IEC 60601-1-8
Annex B (informative) - Types of SOURCES
ANNEX C (informative) - Applicability of types of
system for the distribution of ALARM CONDITIONS
Annex D (informative) - Scalability of types of system
for the distribution of ALARM CONDITIONS
Bibliography
Index of defined terms used in this technical report
Provides 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.
| Committee |
WG 02
|
| DocumentType |
Standard
|
| ISBN |
1-57020-578-7
|
| Pages |
47
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| IEC TR 80001-2-5:2014 | Identical |
| AAMI TIR71 : 2017 | GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| NFPA 72 : 2016 | NATIONAL FIRE ALARM AND SIGNALING CODE |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| VDE 0834-1 : 2016 | Call systems in hospitals, nursing homes and similiar institutions Part 1: Requirements for equipment, planning, erection and operation |
| IEC TR 80001-2-4:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations |
| VDE 0834-2 : 2000 | CALL SYSTEMS IN HOSPITALS, NURSING HOMES AND SIMILAR INSTITUTIONS - ENVIRONMENTAL CONDITIONS AND ELECTROMAGNETIC COMPATIBILITY |
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