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ISO 9241-11 : 1998
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ERGONOMICS OF HUMAN-SYSTEM INTERACTION - PART 11: USABILITY: DEFINITIONS AND CONCEPTS |
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AAMI HE75 : 2009
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HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
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ISO 7010 : 2011
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GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS |
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IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)
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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 |
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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) - PARTIE 11: GUIDANCE ON USABILITY |
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IEC 60601-1:2005+AMD1:2012 CSV
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
|
IEC 60601-1-6 :2013 (CON ED) 3.1
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
|
ISO 13485 : 2016(R2020)
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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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EN 60601-1-6 : 2010 AMD 1 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 : 2.1
|
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 |
|
ISO/IEC GUIDE 63 : 2012
|
GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
|
EN 1041 : 2008 + A1 2013
|
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
|
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
|
ISO 9001:2015
|
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
|
EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
|
EN 60601-1:2006/A1
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005) |
|
ISO 9000 : 2015
|
QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY |
|
AAMI HE74 : 2001
|
HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
|
ISO 14971 : 2007(R2010)
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
|
IEC TR 61258 : 2.0
|
GUIDELINES FOR THE DEVELOPMENT AND USE OF MEDICAL ELECTRICAL EQUIPMENT EDUCATIONAL MATERIALS |
|
EN ISO 7010 : 2012 AMD 7 2017
|
GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016) |
|
EN 60601-1-11 : 2015
|
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 (IEC 60601-1-11:2015) |
|
EN ISO 9000 : 2015
|
QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
|
EN 60601-1-8 : 2007 AMD 11 2017
|
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) |