Source: https://www.document-center.com/standards/ics/11.100.10
Timestamp: 2019-01-20 02:39:59
Document Index: 607242181

Matched Legal Cases: ['art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 1', 'art 2', 'art 3', 'art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 2', 'art 1', 'art 2']

Document Center List of Standards on In Vitro Diagnostic Test Systems
ICS Code 11.100.10
ASTM-F2721 - Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
ASTM-F2944 - Standard Test Method for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture
ASTM-F3142 - Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
BS-EN-12286 - In Vitro Diagnostic Medical Devices, Measurement of Quantities in Samples of Biologica
BS-EN-12376 - In Vitro Diagnostic Medical Devices - Information Supplied the Manufacturer With in Vitro
BS-EN-13640 - Stability testing of in vitro diagnostic reagents
BS-EN-1658 - Requirements for marking of in vitro diagnostic instruments
BS-EN-ISO-15193 - In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
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
BS-EN-ISO-15197 - In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS-EN-ISO-16256 - Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases
BS-EN-ISO-18113-1 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
BS-EN-ISO-18113-2 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
BS-EN-ISO-18113-3 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
BS-EN-ISO-18113-4 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
BS-EN-ISO-18113-5 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
BS-EN-ISO-19001 - In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
BS-EN-ISO-20166-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated RNA
BS-EN-ISO-20166-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated proteins.
BS-EN-ISO-20184-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated RNA
BS-EN-ISO-20184-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated proteins
BS-EN-ISO-23640 - In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS-ISO-17593 - Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
BS-ISO-18113-1 - Part 1: Terms, Definitions & General Requirements, Clinical Laboratory Testing & in V
PD-CEN-16826-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated RNA
PD-CEN-16826-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins
PD-CEN-16826-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated DNA
PD-CEN-16827-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated RNA
PD-CEN-16827-2 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated proteins
PD-CEN-16827-3 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated DNA
PD-CEN-16835-1 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA
PD-CEN-16945 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
ISO-15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
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
ISO-15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO-15198 - Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
ISO-16256 - Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
ISO-17511 - In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
ISO-18112 - Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer
ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO-18153 - 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-19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO-20166-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA
ISO-20166-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins
ISO-20166-3 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
ISO-20184-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA
ISO-20184-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins
ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO-29701 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test
2011/100/EU - Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices Text with EEA relevance
DIN-EN-ISO-20776-1 - Part 1: Reference Method for Testing the In-Vitro Activity of Antimicrobial Agents AGA
DIN-EN-ISO-22870 - Point-of-care testing (POCT) - Requirements for quality and competence
DIN-EN-ISO-29701 - Nanotechnologies. Endotoxin Test on Nanomaterial Samples for in Vitro Systems. Limulus Amebocyte Lysate (Lal) Test
EN-ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
EN-ISO-15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
EN-ISO-15194 - In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biologic
EN-ISO-15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
EN-ISO-16256 - Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
EN-ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
EN-ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
EN-ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
EN-ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
EN-ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
EN-ISO-19001 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
EN-ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN-ISO-29701 - Nanotechnologies. Endotoxin Test on Nanomaterial Samples for in Vitro Systems. Limulus Amebocyte Lysate (Lal) Test
SIS-CEN-ISO/TS-22367 - Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
SIS-CEN/TS-16826-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA
SIS-CEN/TS-16826-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins
SIS-CEN/TS-16827-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA
SIS-CEN/TS-16827-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins
SIS-CEN/TS-16835-1 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
SS-EN-12286 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
SS-EN-12287 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
SS-EN-12376 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
SS-EN-13532 - General requirements for in vitro diagnostic medical devices for self-testing
SS-EN-13612 - Performance evaluation of in vitro diagnostic medical devices
SS-EN-13640 - Stability testing of in vitro diagnostic reagents
SS-EN-13641 - Elimination or reduction of risk of infection related to in vitro diagnostic reagents
SS-EN-13975 - Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
SS-EN-14136 - Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
SS-EN-14254 - In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
SS-EN-1658 - Requirements for marking of in vitro diagnostic instruments
SS-EN-375 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
SS-EN-376 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
SS-EN-591 - Instructions for use for in vitro diagnostic instruments for professional use
SS-EN-592 - Instructions for use for in vitro diagnostic instruments for self-testing
SS-EN-928 - In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
SS-EN-ISO-13079 - Laboratory glass and plastics ware - Tubes for the measurement of erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
SS-EN-ISO-15193 - 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)
SS-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 (ISO 15194:2009)
SS-EN-ISO-17511 - In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
SS-EN-ISO-18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
SS-EN-ISO-18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
SS-EN-ISO-18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
SS-EN-ISO-18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
SS-EN-ISO-18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
SS-EN-ISO-18153 - 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)
SS-EN-ISO-20184-2 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
SS-EN-ISO-20776-1 - Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibiliyt devices - Part 1: Reference methods for testing the in vitro activity of antimicrobial agents against bacteria involved in infectious diseases (ISO 20776-1:2006)
SS-EN-ISO-20776-2 - Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007)
SS-EN-ISO-23640 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
SS-EN-ISO-29701 - Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)
SS-ISO-17593 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2007, IDT)