IEC 80001-1:2010
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Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
IEEE 11073-10421 : 2010
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10421: DEVICE SPECIALIZATION - PEAK EXPIRATORY FLOW MONITOR (PEAK FLOW) |
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 |
ISO/TR 27809:2007
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Health informatics Measures for ensuring patient safety of health software |
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 |
IEEE 11073-10442 : 2008
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10442: DEVICE SPECIALIZATION - STRENGTH FITNESS EQUIPMENT |
ISO/IEEE 11073-30300:2004
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Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless |
ISO/IEEE 11073-10408:2010
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Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEEE/ISO 11073-10420-2010
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IEEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer |
ISO/IEEE 11073-20101:2004
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Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard |
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 |
IEEE 11073-10417-2015
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IEEE Health informatics -- Personal health device communication Part 10417: Device Specialization -- Glucose Meter |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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) |
IEEE 11073-10471 : 2008
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10471: DEVICE SPECIALIZATION - INDEPENDENT LIVING ACTIVITY HUB |
ISO/IEC 27002:2013
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Information technology Security techniques Code of practice for information security controls |
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 |
EN 62304:2006/A1:2015
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
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 |
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 |
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 |
EN 12470-5 : 2003
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CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
EN ISO 18778:2009
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Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
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 |
ISO/IEEE 11073-20601:2016
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Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol |
IEEE 11073-10441-2013
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Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor |
EN ISO 17510-1:2009
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Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
EN 62366 : 2008 AMD 1 2015
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
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 |
ISO/IEEE 11073-10407:2010
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Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor |
ISO/IEEE 11073-10404:2010
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Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter |
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 |
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) |
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 |
IEEE 11073-20601-2014 REDLINE
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IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol |
ISO/IEEE 11073-30200:2004
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Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected |
EN 60601-1-4:1996/A1:1999
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MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
ISO/IEEE 11073-10101:2004
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Health informatics Point-of-care medical device communication Part 10101: Nomenclature |
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 |
ISO/TS 25238:2007
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Health informatics Classification of safety risks from health software |
EN ISO 9919:2009
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Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
ISO/IEEE 11073-10415:2010
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Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale |
IEEE 11073-10472 : 2010
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10472: DEVICE SPECIALIZATION - MEDICATION MONITOR |