IEC 80001-1:2010
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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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IEEE 11073-10421 : 2010
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10421: DEVICE SPECIALIZATION - PEAK EXPIRATORY FLOW MONITOR (PEAK FLOW)
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IEC TR 80002-1:2009
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Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
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ISO/TR 27809:2007
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Health informatics Measures for ensuring patient safety of health software
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EN 60601-2-47:2015
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Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
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IEEE 11073-10442 : 2008
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10442: DEVICE SPECIALIZATION - STRENGTH FITNESS EQUIPMENT
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ISO/IEEE 11073-30300:2004
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Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless
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ISO/IEEE 11073-10408:2010
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Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer
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IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IEEE/ISO 11073-10420-2010
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IEEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer
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ISO/IEEE 11073-20101:2004
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Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard
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IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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IEEE 11073-10417-2015
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IEEE Health informatics -- Personal health device communication Part 10417: Device Specialization -- Glucose Meter
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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EN 60601-1-6:2010/A1:2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
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IEEE 11073-10471 : 2008
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10471: DEVICE SPECIALIZATION - INDEPENDENT LIVING ACTIVITY HUB
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ISO/IEC 27002:2013
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Information technology Security techniques Code of practice for information security controls
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EN 60601-1-1:2001
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Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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EN 62304:2006/A1:2015
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
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IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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EN 60601-2-27:2014
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Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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EN 60601-1-2:2015
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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EN 12470-3:2000+A1:2009
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Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
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EN 12470-5 : 2003
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CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
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IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes
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EN ISO 18778:2009
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Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
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EN 60601-2-30:2000
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Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
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ISO/IEEE 11073-20601:2016
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Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
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IEEE 11073-10441-2013
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Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor
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EN ISO 17510-1:2009
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Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
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EN 62366 : 2008 AMD 1 2015
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
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ISO 9919:2005
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Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
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ISO/IEEE 11073-10407:2010
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Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor
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ISO/IEEE 11073-10404:2010
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Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter
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IEEE 11073-10418-2011
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IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor
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EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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ISO/HL7 27931:2009
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Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments
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IEEE 11073-20601-2014 REDLINE
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IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol
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ISO/IEEE 11073-30200:2004
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Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected
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EN 60601-1-4:1996/A1:1999
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MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
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ISO/IEEE 11073-10101:2004
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Health informatics Point-of-care medical device communication Part 10101: Nomenclature
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IEC 60601-1-4:1996+AMD1:1999 CSV
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Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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ISO/TS 25238:2007
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Health informatics Classification of safety risks from health software
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ISO/IEEE 11073-10415:2010
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Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale
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IEEE 11073-10472 : 2010
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10472: DEVICE SPECIALIZATION - MEDICATION MONITOR
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