ISO 15195:2003
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Laboratory medicine Requirements for reference measurement laboratories
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
04-26-2019
Superseded by
Language(s)
English, French
Published date
10-14-2003
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.
ISO 15195:2003 is not applicable to routine medical laboratories.
The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".
ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.
| DevelopmentNote |
DRAFT ISO/DIS 15195 is also available for this standard. (02/2018)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NS EN ISO 15195 : 1ED 2003 | Identical |
| BS EN ISO 15195:2003 | Identical |
| NF EN ISO 15195 : 2004 | Identical |
| GOST R ISO 15195 : 2006 | Identical |
| SN EN ISO 15195 : 2003 | Identical |
| EN ISO 15195:2003 | Identical |
| UNI EN ISO 15195 : 2004 | Identical |
| NEN EN ISO 15195 : 2003 | Identical |
| ONORM EN ISO 15195 : 2004 | Identical |
| UNE-EN ISO 15195:2004 | Identical |
| PN EN ISO 15195 : 2004 | Identical |
| I.S. EN ISO 15195:2003 | Identical |
| DIN EN ISO 15195:2004-01 | Identical |
| BS EN ISO 15194:2009 | In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation |
| 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 |
| ASTM E 2538 : 2006 : R2011 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020) |
| I.S. EN ISO 15194:2009 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| 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 |
| 07/30157023 DC : 0 | BS EN ISO 15194 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| I.S. EN ISO 17034:2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016) |
| ASTM E 2538 : 2006 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| ECA ILAC P14 : 2013 | ILAC POLICY FOR UNCERTAINTY IN CALIBRATION |
| UNE-EN ISO 17034:2017 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| 09/30205176 DC : 0 | ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY |
| 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 |
| DIN EN ISO 15194:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| CEI UNI EN ISO 17034 : 1ED 2018 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| BS ISO 17034 : 2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| EN ISO 17034:2016 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| EN ISO 15194:2009 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009) |
| BS EN ISO 17034:2016 | General requirements for the competence of reference material producers |
| UNI EN ISO 15194 : 2009 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| BS EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| DIN EN 14136:2004-08 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO/IEC Guide 58:1993 | Calibration and testing laboratory accreditation systems General requirements for operation and recognition |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| 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 |
| EN ISO 18153:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| 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 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 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 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 17511:2003) |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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