IEC 61025:2006
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Fault tree analysis (FTA)
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ISO 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
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IEC 60812:2006
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Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
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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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EN 1441 : 1997
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MEDICAL DEVICES - RISK ANALYSIS
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ISO 15189:2012
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Medical laboratories — Requirements for quality and competence
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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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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements
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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements
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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
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IEC TR 60513:1994
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Fundamental aspects of safety standards for medical electrical equipment
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ISO 15198:2004
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Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
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ISO 18153:2003
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In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
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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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ISO 19001:2013
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In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards
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ISO 17511:2003
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In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
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ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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IEC 60300-3-9:1995
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Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
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ISO 17593:2007
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Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary
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ISO/IEC Guide 2:2004
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Standardization and related activities General vocabulary
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EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
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ISO 15197:2013
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In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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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 9000-3:1997
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Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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