ISO ColIection 105/300:ISO/TC 212 - Clinical laboratory testing and in vitro

[BornToSin]

full list:

ISO 15189:2012 Medical laboratories -- Requirements for quality and competence
ISO 15190:2003 Medical laboratories -- Requirements for safety
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
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 15195:2003 Laboratory ******** -- Requirements for reference measurement laboratories
ISO 15197:2013 In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15198:2004 Clinical laboratory ******** -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
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
ISO/TS 16782:2016 Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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/TS 17518:2015 Medical laboratories -- Reagents for staining biological material -- Guidance for users
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO/TS 17822-1:2014 In vitro diagnostic test systems -- Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens -- Part 1: General requirements* terms and definitions
ISO 18113-1:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms* definitions and general requirements
ISO 18113-2:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
ISO 18113-4:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-5:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
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 19001:2013 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Reference method for testing the in vitro activity of ant
ISO 20776-2:2007 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
ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO/TS 22367:2008/Cor 1:2009 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
ISO 22870:2016 Point-of-care testing (POCT) -- Requirements for quality and competence
ISO 23640:2011 In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents


the missing are:

ISO/TS 16782:2016 Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003



links:

[link Point to another website Only the registered members can access]
or

[link Point to another website Only the registered members can access]

[BornToSin]

added one:

ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003

still missing:

ISO/TS 16782:2016 Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing


new link:

[link Point to another website Only the registered members can access]

[BornToSin]

update:

BQ or EN or missing:

ISO 15198:2004 Clinical laboratory ******** -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
ISO/TS 16782:2016 Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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 20776-2:2007 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
ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO/TS 22367:2008/Cor 1:2009 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO 22870:2016 Point-of-care testing (POCT) -- Requirements for quality and competence



complete

[link Point to another website Only the registered members can access]

[BornToSin]

full list 11.12.2017.

ISO 15189:2012 Medical laboratories -- Requirements for quality and competence
ISO 15190:2003 Medical laboratories -- Requirements for safety
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
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 15195:2003 Laboratory ******** -- Requirements for reference measurement laboratories
ISO 15197:2013 In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15198:2004 Clinical laboratory ******** -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
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
ISO/TS 16782:2016 Clinical laboratory testing -- Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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/TS 17518:2015 Medical laboratories -- Reagents for staining biological material -- Guidance for users
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO/TS 17822-1:2014 In vitro diagnostic test systems -- Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens -- Part 1: General requirements, terms and definitions
ISO 18113-1:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
ISO 18113-2:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
ISO 18113-4:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-5:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
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 19001:2013 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO/TS 20658:2017 Medical laboratories -- Requirements for collection, transport, receipt, and handling of samples
ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Reference method for testing the in vitro activity of ant
ISO 20776-2:2007 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
ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO/TS 22367:2008/Cor 1:2009 Medical laboratories -- Reduction of error through risk management and continual improvement
ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
ISO 22870:2016 Point-of-care testing (POCT) -- Requirements for quality and competence
ISO 23640:2011 In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents


complete

[link Point to another website Only the registered members can access]