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DIN EN ISO 15194:2009-10

Действует
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); German version EN ISO 15194:2009 — 27 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN 820-120:2008-09
Отменен
Standardization - Part 120: Guidelines for the inclusion of safety aspects in standards (ISO/IEC Guide 51:1999) — 18 стр.
DIN EN ISO 14971:2009-10
Отменен
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009 — 103 стр.
DIN EN ISO 15193:2009-10
Действует
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); German version EN ISO 15193:2009 — 31 стр.
DIN EN ISO 15195:2004-01
Отменен
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003) — 21 стр.
DIN EN ISO/IEC 17025:2005-08
Отменен
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005 — 73 стр.
DIN EN ISO 17511:2003-11
Отменен
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003); German version EN ISO 17511:2003 — 35 стр.
DIN EN ISO 18153:2003-11
Действует
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); German version EN ISO 18153:2003 — 17 стр.
DIN ISO 5725-2:2002-12
Отменен
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) — 97 стр.
DIN EN 980:2008-08
Отменен
Symbols for use in the labelling of medical devices; German version EN 980:2008 — 37 стр.
PD ISO Guide 30:1993+A1:2008
Заменен
Reference materials, Guide to terms and definitions used in connection with reference materials — 16 стр.
PD ISO Guide 34:2009
Заменен
General requirements for the competence of reference material producers — 46 стр.
BS ISO 31-0:1992
Заменен
Quantities and units. General principles — 28 стр.
BS ISO 31-9:1992
Заменен
Quantities and units. Atomic and nuclear physics — 30 стр.
BS ISO 31-10:1992
Заменен
Quantities and units. Nuclear reactions and ionizing radiations — 34 стр.
BS ISO 31-11:1992
Заменен
Quantities and units. Mathematical signs and symbols for use in the physical sciences and technology — 36 стр.
DIN EN ISO 13485:2007-10
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007 — 75 стр.
DIN EN ISO/IEC 17025 Berichtigung 2:2007-05
Отменен
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005, Corrigenda to DIN EN ISO/IEC 17025:2005-08; German and English version EN ISO/IEC 17025:2005/AC:2006 — 4 стр.
DIN EN 12287:1999-08
Отменен
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials; German version EN 12287:1999 — 20 стр.

На этот документ ссылаются

DIN EN ISO 18113-1:2010-05
Отменен
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2009 — 62 стр.
DIN EN ISO 18113-1:2013-01
Действует
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 — 60 стр.
DIN EN 12287:1999-08
Отменен
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials; German version EN 12287:1999 — 20 стр.
DIN EN ISO 15189:2013-03
Отменен
Medical laboratories - Requirements for quality and competence (ISO 15189:2012); German version EN ISO 15189:2012 — 66 стр.
DIN EN ISO 15189:2014-11
Действует
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) — 66 стр.
DIN EN ISO 15197:2013-11
Отменен
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2013 — 59 стр.
DIN EN ISO 15197:2004-05
Отменен
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003); German version EN ISO 15197:2003, text German and English — 84 стр.
DIN EN ISO 15197:2013-09
Отменен
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013), German version EN ISO 15197:2013 — 59 стр.
DIN EN ISO 15189:2007-08
Отменен
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007); German version EN ISO 15189:2007 — 48 стр.
DIN EN ISO 15193:2009-10
Действует
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); German version EN ISO 15193:2009 — 31 стр.
DIN EN ISO 15197:2015-12
Действует
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 — 63 стр.
DIN EN ISO 17034:2017-04
Действует
General requirements for the competence of reference material producers (ISO 17034:2016); German and English version EN ISO 17034:2016 — 67 стр.
DIN EN ISO/IEC 17025:2018-03
Действует
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 — 65 стр.
DIN EN ISO 15195:2004-01
Отменен
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003) — 21 стр.