AAMI SW87 : 2012
|
APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS |
15/30328959 DC : 0
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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 11073-10419:2016
|
Health informatics. Personal health device communication Device specialization. Insulin pump |
I.S. 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) |
16/30346073 DC : 0
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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
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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
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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
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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
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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
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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 |