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.
Aerospace series - Nuts, anchor, self-locking, fixed, 60° corner, with counterbore, in alloy steel, cadmium plated, MoS<(Index)2> lubricated - Classification: 1100 MPa (at ambient temperature)/235 °C; German and English version EN 3753:2010— 18 стр.
Aerospace series - Nuts, anchor, self-locking, one lug, fixed, reduced series, with counterbore, in heat resisting steel, MoS<(Index)2> lubricated - Classification: 1100 MPa (at ambient temperature)/315 °C; German and English version EN 3768:2012— 17 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009— 75 стр.
Prevailing torque type hexagon nuts (with non-metallic insert), style 1 - Property classes 5, 8 and 10 (ISO/FDIS 7040:2012); German version FprEN ISO 7040:2012
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.
Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability (ISO 3534-1:2006); Text in German and English— 96 стр.
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.
Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method (ISO 5725-5:1998), Corrigenda to DIN ISO 5725-5:2002-11 (ISO 5725-5:1998/Cor. 1:2005)— 2 стр.
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.
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.
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.
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO/DIS 15197:2010); German version prEN ISO 15197:2010
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
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.
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy— 64 стр.
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)
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.
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.
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.
Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method (ISO 5725-3:1994 including Technical Corrigendum 1:2001)— 65 стр.
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.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2009— 18 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2009— 19 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2009— 22 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2009— 21 стр.
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.
