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

Standard No.

ISO/TS 17822-1:2014

Release Date

2014

Published By

International Organization for Standardization (ISO)

Latest

ISO/TS 17822-1:2014

ISO/TS 17822-1:2014 Referenced Document

• ISO ISO IEC 27001-2013 cor2-2015 technical errata*， 2023-12-21 Update
• ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 15189:2012 Medical laboratories - Requirements for quality and competence
• ISO 15190:2003 Medical laboratories - Requirements for safety
• 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 21569:2005 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Qualitative nucleic acid based methods
• ISO 21571:2005 Foodstuffs - Methods of analysis for the detection of genetically modified organisms and derived products - Nucleic acid extraction
• ISO 21572:2013 Foodstuffs - Molecular biomarker analysis - Protein-based methods
• ISO 21748:2010 Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation
• ISO 22174:2005 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions
• ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions
• ISO 5725-2:1994 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 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method
• ISO/TS 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement

ISO/TS 17822-1:2014 history

• 2014 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