IEC TR 80001-2-5:2014
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 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
16-12-2014
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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
IEC TR 80001-2-5:2014(E) which is a 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 communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.
| DevelopmentNote |
Stability date: 2018. (12/2014)
|
| DocumentType |
Technical Report
|
| Pages |
39
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Standards | Relationship |
| AAMI/IEC TIR80001-2-5:2014 | Identical |
| VDE 0756-2-5 : 2016 | Identical |
| DIN IEC/TR 80001-2-5 : 2016 | Identical |
| PD IEC/TR 80001-2-5:2014 | Identical |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 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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