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ISO 18113-1:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

06-10-2022

Language(s)

English, French, Russian

Published date

09-12-2009

Publisher

International Organization for Standardization

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

DevelopmentNote
Supersedes ISO/DIS 18113-1. (12/2009)
DocumentType
Standard
Pages
49
ProductNote
THIS STANDARD ALSO REFERS TO ISO 25680,ISO/IEC 80000,ISO/IEC 80416-1
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy

15/30320144 DC : 0 BS EN 16785-2 - BIO-BASED PRODUCTS - BIO-BASED CONTENT - PART 2: DETERMINATION OF THE BIO-BASED CONTENT USING THE MATERIAL BALANCE METHOD
DIN EN ISO 18113-4:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
UNI EN ISO 18113-5 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING
DIN EN ISO 18113-3:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment
UNE-EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
UNE-EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use
BIS IS/ISO 15197 : 2013 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
CEI EN 61326-2-6 : 2014 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
UNI EN ISO 18113-4 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
UNI EN ISO 19001 : 2013 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY
PD ISO/TS 17822-1:2014 <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
06/30146526 DC : 0 BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
06/30146522 DC : 0 BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
16/30335561 DC : DRAFT APR 2016 BS ISO 37102 - SUSTAINABLE DEVELOPMENT AND RESILIENCE OF COMMUNITIES - VOCABULARY
06/30146515 DC : 0 BS ISO 18113-2 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
BS EN ISO 18113-4:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
DIN EN ISO 18113-2:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
ANSI/AAMI/ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
ISO 37100:2016 Sustainable cities and communities — Vocabulary
I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
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
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
I.S. EN 61326-2-6:2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV))
BS ISO 37100:2016 Sustainable cities and communities. Vocabulary
10/30228700 DC : 0 BS EN ISO 19001 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY
I.S. EN ISO 23640:2015 IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
I.S. EN ISO 19001:2013 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013)
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Z316.8-18 Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions
BS EN ISO 18113-2:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
UNI EN ISO 18113-2 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
11/30208525 DC : 0 BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
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
EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
BS EN ISO 18113-5:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing
UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
I.S. EN ISO 18113-4:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
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
BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
I.S. EN ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 19001:2013 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
UNE-EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
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 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
DIN EN ISO 15223-1:2015-08 (Draft) MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
UNE-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
06/30146518 DC : 0 BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
I.S. EN ISO 18113-2:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
DIN EN ISO 19001:2013-07 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013)
UNI EN ISO 18113-3 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
I.S. EN ISO 18113-5:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
I.S. EN ISO 18113-3:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
DIN EN ISO 23640:2015-12 IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
DIN EN ISO 15197:2015-12 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
CLSI C49:2018(R2023) Analysis of Body Fluids in Clinical Chemistry

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 10241:1992 International terminology standards Preparation and layout
ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
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
EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
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 15189:2012 Medical laboratories — Requirements for quality and competence
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
EN 13640:2002 Stability testing of in vitro diagnostic reagents
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
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
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
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
CLSI C28 A2 : 2ED 2000 HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
ISO 15190:2003 Medical laboratories Requirements for safety
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO Guide 30:2015 Reference materials Selected terms and definitions
CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
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
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
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 9000:2015 Quality management systems — Fundamentals and vocabulary
IEC 60359:2001 Electrical and electronic measurement equipment - Expression of performance
AS ISO 37100:2020 Sustainable cities and communities - Vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 704:2009 Terminology work — Principles and methods
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN 980:2008 Symbols for use in the labelling of medical devices
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
IEC 60050-300:2001 International Electrotechnical Vocabulary (IEV) - Part 300: Electrical and electronic measurements and measuring instruments - Part 311: General terms relating to measurements - Part 312: General terms relating to electrical measurements - Part 313: Types of electrical measuring instruments - Part 314: Specific terms according to the type of instrument
ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
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PDF 5 Users - French
PDF 9 Users - French
Hardcopy - Russian
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PDF 5 Users - Russian
PDF 9 Users - Russian
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
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PDF 1 User - French
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PDF 5 Users - French
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