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IEC TR 80001-2-1:2012

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

05-04-2024

Language(s)

English

Published date

10-07-2012

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Prerequisites
5 Study of terms used in RISK MANAGEMENT
6 The steps
7 IEC 80001-1:2010, Clause 4.4: Step by step
8 Practical examples
Annex A (informative) - Common HAZARDS,
        HAZARDOUS SITUATIONS, and causes to
        consider in MEDICAL IT-NETWORKS
Annex B (informative) - List of questions to consider
        when identifying HAZARDs of the MEDICAL IT-NETWORK
Annex C (informative) - Layers of MEDICAL IT-NETWORKS where
        errors can be found
Annex D (informative) - Probability, severity, and RISK
        acceptability scales used in the examples in this
        technical report
Annex E (informative) - MONITORING RISK mitigation
        effectiveness
Annex F (informative) - RISK ANALYZING small changes in a
        MEDICAL IT-NETWORK
Annex G (informative) - Example of Change Window Form
Annex H (informative) - Template for examples
Bibliography

IEC/TR 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.

Committee
TC 62/SC 62A
DevelopmentNote
Stability date: 2017. (09/2017)
DocumentType
Technical Report
Pages
66
PublisherName
International Electrotechnical Committee
Status
Withdrawn

16/30346073 DC : 0 BS ISO 16142-2 - 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
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
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
EN 62453-1:2017 Field Device Tool (FDT) interface specification - Part 1: Overview and guidance
PD ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices. Application guidance Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
PD IEC/TR 80001-2-9:2017 Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
AAMI IEC TIR 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
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
I.S. EN 62453-1:2017 FIELD DEVICE TOOL (FDT) INTERFACE SPECIFICATION - PART 1: OVERVIEW AND GUIDANCE
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
NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
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
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BS EN 62453-1:2017 Field Device Tool (FDT) interface specification Overview and guidance
PD IEC/TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices Application guidance. General implementation guidance for healthcare delivery organizations
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
PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
PD IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
AAMI/IEC TIR80001-2-4:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-4: GENERAL IMPLEMENTATION GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC 62453-1:2016 Field device tool (FDT) interface specification - Part 1: Overview and guidance
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
PD IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
IEC TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
AAMI/IEC TIR80001-2-7:2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1
ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/TS 19218-2:2012 Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes
ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
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 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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