ISO 19001:2013 - $103.00   BUY NOW

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

ISO 19001:2013 Publication Description:

ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Diagnostic Equipment (11.040.55)
ICS-11-Health ICS In Vitro Diagnostic Test Systems (11.100.10)

ICS Related Standards

Cart Document Number Document Title
$103.00 ISO/TR 13154:2009 Medical electrical equipment - Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph
$45.00 ISO/TS 18339:2015 Endotherapy devices - Eyepiece cap and light guide connector
$68.00 ISO/TS 18340:2015 Endoscopes - Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
$185.00 ISO 80601-2-56:2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
$103.00 ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
$123.00 ISO 8600-1:2013 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
$103.00 ISO 8600-2:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 2: Particular requirements for rigid bronchoscopes
$88.00 ISO 8600-2:2002 Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 2: Particular requirements for rigid bronchoscopes
$45.00 ISO 8600-3:1997 Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 3: Determination of field of view and direction of view of endoscopes with optics
$19.00 ISO 8600-3/Amd1:2003 Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics - Amendment 1
$45.00 ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Part 4: Determination of maximum width of insertion portion
$45.00 ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
$68.00 ISO 8600-6:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
$45.00 ISO 8600-7:2012 Endoscopes - Medical endoscopes and endotherapy devices - Part 7: Basic requirements for medical endoscopes of water-resistant type
$138.00 ISO/TR 13154:2017 Medical electrical equipment - Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
$138.00 ISO 19614:2017 Traditional Chinese medicine - Pulse graph force transducer
$185.00 ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
$103.00 ISO 13079:2011 Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
$138.00 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
$103.00 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
$185.00 ISO 15197:2013 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
$68.00 ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
$103.00 ISO 16256:2012 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
$138.00 ISO 17511:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
$275.00 ISO/TR 18112:2006 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
$185.00 ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
$68.00 ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
$68.00 ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
$68.00 ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
$68.00 ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
$68.00 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
$68.00 ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
$138.00 ISO 29701:2010 Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test