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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
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ISO 5725-1:1994
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Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
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EN 591 : 2001
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
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EN 13612:2002/AC:2002
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PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES |
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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 15189:2012
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Medical laboratories — Requirements for quality and competence |
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
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EN 592 : 2002
|
INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
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EN 13640:2002
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Stability testing of in vitro diagnostic reagents |
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ISO 5725-3:1994
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Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method |
|
EN 376 : 2002
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
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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/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
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ISO 17511:2003
|
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 3534-2:2006
|
Statistics Vocabulary and symbols Part 2: Applied statistics |
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ISO 15190:2003
|
Medical laboratories Requirements for safety |
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times |
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EN 375 : 2001
|
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
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ISO Guide 30:2015
|
Reference materials Selected terms and definitions |
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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 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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EN 980:2008
|
Symbols for use in the labelling of medical devices |
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ISO 3534-1:2006
|
Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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ISO 15223:2000
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |