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ISO/TS 17822-1:2014

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

07-16-2021

Language(s)

English

Published date

12-09-2014

Publisher

International Organization for Standardization

ISO/TS 17822-1:2014 is intended for

? IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and

? medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.

This part of ISO/TS 17822 does not apply to

? nucleic acid-based examinations that are not intended for in vitro diagnostic use, or

? quantitative nucleic acid-based in vitro diagnostic examination procedures.

DocumentType
Technical Specification
Pages
22
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

Standards Relationship
PD ISO/TS 17822-1:2014 Identical

17/30331313 DC : 0 BS EN ISO 20186-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA CORRECT
17/30326658 DC : 0 BS EN ISO 20186-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA

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 21572:2013 Foodstuffs Molecular biomarker analysis Protein-based methods
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
CLSI EP23 A : 1ED 2011 LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
ISO/TR 22971:2005 Accuracy (trueness and precision) of measurement methods and results Practical guidance for the use of ISO 5725-2:1994 in designing, implementing and statistically analysing interlaboratory repeatability and reproducibility results
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 24276:2006 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions
CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
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
CLSI EP24 A2 : 2ED 2011 ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES
ISO 21571:2005 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Nucleic acid extraction
CLSI EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
ISO 15190:2003 Medical laboratories Requirements for safety
CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
ISO 21569:2005 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products Qualitative nucleic acid based methods
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 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
ISO 21748:2017 Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty evaluation
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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