ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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ISO Guide 32:1997
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Calibration in analytical chemistry and use of certified reference materials
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DIN EN ISO 15193:2009-10
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
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ISO 15195:2003
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Laboratory medicine Requirements for reference measurement laboratories
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DIN ISO 5725-2:2002-12
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Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method (ISO 5725-2:1994 including Technical Corrigendum 1:2002)
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DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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DIN EN ISO 17511:2003-11
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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 (ISO 17511:2003)
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ISO 15193:2009
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In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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DIN EN ISO 18113-2:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
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ISO Guide 33:2015
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Reference materials — Good practice in using reference materials
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DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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ISO Guide 35:2017
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Reference materials — Guidance for characterization and assessment of homogeneity and stability
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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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ISO/IEC Guide 63:2012
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Guide to the development and inclusion of safety aspects in International Standards for medical devices
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ISO/IEC Guide 99:2007
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International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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ISO/IEC Guide 15:1977
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ISO/IEC code of principles on "reference to standards"
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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 Guide 30:2015
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Reference materials Selected terms and definitions
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ISO 5725-2:1994
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Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
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DIN 820-120:2012-09
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STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999)
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO Guide 31:2015
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Reference materials — Contents of certificates, labels and accompanying documentation
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EN 980:2008
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Symbols for use in the labelling of medical devices
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ISO Guide 34:2009
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General requirements for the competence of reference material producers
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ISO/IEC Guide 98-3:2008
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Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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