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IEC 80001-1:2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

09-21-2021

Language(s)

English, English - French, Spanish, Castilian

Published date

10-27-2010

IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), 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 (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.

Committee
TC 62/SC 62A
DevelopmentNote
Stability Date: 2015. (10/2012)
DocumentType
Standard
Pages
90
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy

AAMI SW87 : 2012 APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS
15/30328959 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
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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
BS EN ISO 11073-20601:2016 Health informatics. Personal health device communication Application profile. Optimized exchange protocol
I.S. EN ISO 11073-10419:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION PART 10419: DEVICE SPECIALIZATION - INSULIN PUMP (ISO/IEEE 11073-10419:2016)
I.S. EN ISO 11073-10424:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10424: DEVICE SPECIALIZATION - SLEEP APNOEA BREATHING THERAPY EQUIPMENT (SABTE) (ISO/IEEE 11073-10424:2016)
BS EN ISO 11073-10424:2016 Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE)
AAMI/IEC TIR80001-2-8:2016 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC 80001-2-2
AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
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
BS EN ISO 11073-10427:2018 Health informatics. Personal health device communication Device specialization. Power status monitor of personal health devices devices
ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
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
17/30359001 DC : 0 BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES
I.S. EN 82304-1:2017 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
ISO/IEEE 11073-10425:2016 Health informatics Personal health device communication Part 10425: Device specialization Continuous glucose monitor (CGM)
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
BS ISO/IEEE 11073-10441 : 2015 COR 2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR
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
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
11/30193150 DC : 0 BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
EN 82304-1:2017 Health Software - Part 1: General requirements for product safety
I.S. EN ISO 11073-10427:2018 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10427: DEVICE SPECIALIZATION - POWER STATUS MONITOR OF PERSONAL HEALTH DEVICES (ISO/IEEE 11073-10427:2018)
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
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
AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
ISO/IEEE 11073-10418:2014 Health informatics Personal health device communication Part 10418: Device specialization International Normalized Ratio (INR) monitor
ISO/IEEE 11073-10441:2015 Health informatics Personal health device communication Part 10441: Device specialization Cardiovascular fitness and activity monitor
NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
PD ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
BS EN 82304-1:2017 Health Software General requirements for product safety
UNI EN ISO 11073-30400 : 2013 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET
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
BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
BS EN ISO 11073-30400:2012 Health informatics. Point-of-care medical device communication Interface profile. Cabled Ethernet
ISO/IEEE 11073-10427:2018 Health informatics — Personal health device communication — Part 10427: Device specialization — Power status monitor of personal health devices
IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
I.S. EN ISO 11073-10441:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10441: DEVICE SPECIALIZATION - CARDIOVASCULAR FITNESS AND ACTIVITY MONITOR (ISO/IEEE 11073-10441:2015)
IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
EN ISO 11073-10424:2016/AC:2018 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10424: DEVICE SPECIALIZATION - SLEEP APNOEA BREATHING THERAPY EQUIPMENT (SABTE) (ISO/IEEE 11073-10424:2016)
IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
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
I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
IEEE 11073-10419-2015 IEEE Health informatics- Personal health device communication- Part 10419: Device Specialization- Insulin Pump
AAMI/IEC TIR80002-1:2009 MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
PD IEC/TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
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
ANSI/AAMI/IEC TIR80001-2-1:2012 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
14/30290166 DC : 0 BS ISO 16142-1 - 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 TIR80001-2-4:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-4: GENERAL IMPLEMENTATION GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS
PD IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
BS EN ISO 11073-10441:2017 Health informatics. Personal health device communication Device specialization. Cardiovascular fitness and activity monitor
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
PD IEC/TR 80002-1:2009 Medical device software Guidance on the application of ISO 14971 to medical device software
ISO/IEEE 11073-10424:2016 Health informatics Personal health device communication Part 10424: Device specialization Sleep apnoea breathing therapy equipment (SABTE)
ISO/TS 20405:2018 Health informatics Framework of event data and reporting definitions for the safety of health software
I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
IEEE 11073-10427-2016 IEEE Standard - Health informatics--Personal health device communication - Part 10427: Device specialization--Power Status Monitor of Personal Health Devices
ISO/IEEE 11073-10422:2017 Health informatics — Personal health device communication — Part 10422: Device specialization — Urine analyser
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
BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
PD IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
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
ISO/IEEE 11073-30400:2012 Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet
BS EN ISO 11073-30200 : 2005 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED
ISO/IEEE 11073-20601:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
EN ISO 11073-10419:2016 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2016, Corrected version 2018-03)
EN ISO 11073-20601:2016 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol (ISO/IEEE 11073-20601:2016, including Cor 1:2016)
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
EN ISO 11073-30200:2005/A1:2015 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED (ISO/IEEE 11073- 30200:2004/AMD 1:2015)
EN ISO 11073-30400:2012 Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)
EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
EN ISO 11073-10441:2017 Health informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor (ISO/IEEE 11073-10441:2015)
15/30246774 DC : 0 BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
IEEE 11073-10441-2013 Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor
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
BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
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
I.S. EN ISO 11073-10425:2016 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10425: DEVICE SPECIALIZATION - CONTINUOUS GLUCOSE MONITOR (CGM) (ISO 11073-10425:2016)
EN ISO 11073-10427:2018 Health informatics - Personal health device communication - Part 10427: Device specialization - Power status monitor of personal health devices(ISO/IEEE 11073-10427:2018)
I.S. EN ISO 11073-30400:2012 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30400: INTERFACE PROFILE - CABLED ETHERNET (ISO 11073-30400:2012)
IEEE 11073-10425-2014 Health informatics--Personal health device communication - Part 10425: Device Specialization--Continuous Glucose Monitor (CGM)
UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
IEEE 11073-10418-2011 IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor
BS IEC 82304-1 : 2016 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
BS EN ISO 11073-10425:2016 Health informatics. Personal health device communication Device specialization. Continuous glucose monitor (CGM)
NF EN ISO 11073-10406 : 2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
IEEE 11073-20601-2014 REDLINE IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol
IEEE 11073-10424-2014 IEEE Standard - Health informatics--Personal health device communication - Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE)
EN ISO 11073-10425:2016 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ISO/TS 13131:2014 Health informatics Telehealth services Quality planning guidelines
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
EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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ISO 31000:2009 Risk management Principles and guidelines
ISO/IEC 20000-1:2011 Information technology Service management Part 1: Service management system requirements
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
ISO/IEC 15026-2:2011 Systems and software engineering — Systems and software assurance — Part 2: Assurance case
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