ISO 9241-11:1998
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Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability |
ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs |
AAMI HE48 : 1993
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HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
EN ISO 9241-11:1998
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Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998) |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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 |
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) |
IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
ISO/IEC Guide 63:2012
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Guide to the development and inclusion of safety aspects in International Standards for medical devices |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
EN ISO 9001:2015
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Quality management systems - Requirements (ISO 9001:2015) |
ISO 9001:2015
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Quality management systems — Requirements |
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 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
IEC TR 61258:2008
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Guidelines for the development and use of medical electrical equipment educational materials |
EN ISO 7010 : 2012 AMD 7 2017
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GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016) |
EN 60601-1-11:2015
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Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
EN ISO 9000:2015
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Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
EN 60601-1-8:2007/A11:2017
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |