ISO 15194:2009
Current
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French, Russian
Published date
28-04-2009
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
| DevelopmentNote |
Supersedes ISO/DIS 15194. (04/2009)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 15194:2009 | Identical |
| NEN EN ISO 15194 : 2009 | Identical |
| UNI EN ISO 15194 : 2009 | Identical |
| I.S. EN ISO 15194:2009 | Identical |
| NBN EN ISO 15194 : 2009 | Identical |
| PN EN ISO 15194 : 2009 | Identical |
| NS EN ISO 15194 : 2009 | Identical |
| NF EN ISO 15194 : 2009 | Identical |
| DIN EN ISO 15194:2009-10 | Identical |
| SN EN ISO 15194:2009 | Identical |
| UNE-EN ISO 15194:2009 | Identical |
| BS EN ISO 15194:2009 | Identical |
| GOST R ISO 15194 : 2013 | Identical |
| DIN EN 12287:1999-08 | Corresponds |
| NEN ISO 15194 : 2002 | Identical |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| BIS IS/ISO 15189 : 2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| DIN EN ISO 15193:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| I.S. EN ISO 15189:2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15) |
| I.S. EN ISO 15195:2003 | LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES |
| BS EN 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 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| I.S. EN ISO 17034:2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016) |
| UNI CEN/TS 15968 : 2010 | Determination of extractable perfluoro octane sulfonate (PFOS) in solid, coated and impregnated articles, in liquids and fire-fighting foams - Method for sampling, extraction and analysis by means of LC-qMS or LC-MS |
| BS EN ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| PREN ISO 15189 : DRAFT 2011 | MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNE-EN ISO 15189:2013 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| BS ISO 15198:2004 | Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer |
| UNE-EN ISO 17034:2017 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| 11/30173018 DC : 0 | BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| 09/30205176 DC : 0 | ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| BS EN ISO 15195:2003 | Laboratory medicine. Requirements for reference measurement laboratories |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| DIN EN ISO 15189:2014-11 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| UNI EN ISO 15189 : 2013 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| UNI EN 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 |
| NF EN ISO 15195 : 2004 | LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES |
| PD CEN/TS 15968:2010 | Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams. Method for sampling, extraction and analysis by LCqMS or LC-tandem/MS |
| NF EN 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 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| CEI UNI EN ISO 17034 : 1ED 2018 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| CSA Z15189 : 2003 | MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| BS ISO 17034 : 2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| S.R. CEN/TS 15968:2010 | DETERMINATION OF EXTRACTABLE PERFLUOROOCTANESULPHONATE (PFOS) IN COATED AND IMPREGNATED SOLID ARTICLES, LIQUIDS AND FIRE FIGHTING FOAMS - METHOD FOR SAMPLING, EXTRACTION AND ANALYSIS BY LC-QMS OR LC-TANDEM/MS |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| I.S. EN 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 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 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| UNE-EN ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017) |
| BS EN ISO 15189:2012 | Medical laboratories. Requirements for quality and competence |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| EN 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 15193:2009) |
| EN ISO 17034:2016 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| BS EN ISO 17034:2016 | General requirements for the competence of reference material producers |
| DIN EN ISO 18113-1:2013-01 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| 15/30327269 DC : 0 | BS EN ISO 17034 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| PD ISO GUIDE 33:2015 | Reference materials. Good practice in using reference materials |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| ISO Guide 33:2015 | Reference materials Good practice in using reference materials |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| EN ISO 15195:2003 | Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003) |
| CEN/TS 15968:2010 | Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams - Method for sampling, extraction and analysis by LC-qMS or LC-tandem/MS |
| DIN EN ISO 15195:2004-01 | LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES |
| CLSI C49:2018(R2023) | Analysis of Body Fluids in Clinical Chemistry |
| 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 |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| 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 |
| ISO Guide 33:2015 | Reference materials Good practice in using reference materials |
| 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 |
| 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) |
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