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ISO/IEC 17025:2005
|
General requirements for the competence of testing and calibration laboratories |
|
ISO Guide 32:1997
|
Calibration in analytical chemistry and use of certified reference materials |
|
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 |
|
ISO 15195:2003
|
Laboratory medicine Requirements for reference measurement laboratories |
|
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) |
|
DIN EN ISO 13485:2016-08
|
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
|
DIN EN ISO 17511:2003-11
|
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
|
ISO 15193:2009
|
In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
DIN EN ISO 18113-2:2013-01
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
|
ISO Guide 33:2015
|
Reference materials Good practice in using reference materials |
|
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
|
ISO Guide 35:2017
|
Reference materials Guidance for characterization and assessment of homogeneity and stability |
|
ISO 18153:2003
|
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 |
|
ISO/IEC Guide 63:2012
|
Guide to the development and inclusion of safety aspects in International Standards for medical devices |
|
ISO/IEC Guide 99:2007
|
International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
|
ISO/IEC Guide 15:1977
|
ISO/IEC code of principles on "reference to standards" |
|
ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
|
ISO 17511:2003
|
In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
|
ISO Guide 30:2015
|
Reference materials Selected terms and definitions |
|
ISO 5725-2:1994
|
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 |
|
DIN 820-120:2012-09
|
STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999) |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO Guide 31:2015
|
Reference materials — Contents of certificates, labels and accompanying documentation |
|
EN 980:2008
|
Symbols for use in the labelling of medical devices |
|
ISO Guide 34:2009
|
General requirements for the competence of reference material producers |
|
ISO/IEC Guide 98-3:2008
|
Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |