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Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
10-06-2022
Superseded by
Language(s)
English, French, Russian
Published date
12-09-2009
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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)
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| DocumentType |
Standard
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| Pages |
49
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| ProductNote |
THIS STANDARD ALSO REFERS TO ISO 25680,ISO/IEC 80000,ISO/IEC 80416-1
|
| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| GOST R ISO 18113-1 : 2015 | Identical |
| NF EN ISO 18113-1 : 2012 | Identical |
| NBN EN ISO 18113-1 : 2011 | Identical |
| NEN EN ISO 18113-1 : 2011 | Identical |
| NS EN ISO 18113-1 : 2011 | Identical |
| I.S. EN ISO 18113-1:2011 | Identical |
| PN EN ISO 18113-1 : 2013 | Identical |
| SAC GB/T 29791-1 : 2013 | Identical |
| SN EN ISO 18113-1 : 2012 | Identical |
| UNI EN ISO 18113-1 : 2012 | Identical |
| SS-EN ISO 18113-1 : 2011 | Identical |
| UNE-EN ISO 18113-1:2012 | Identical |
| BS EN ISO 18113-1:2011 | Identical |
| EN ISO 18113-1:2011 | Identical |
| DIN EN ISO 18113-1:2013-01 | Identical |
| DS EN ISO 18113-1 : 2011 | Identical |
| ONORM EN ISO 18113-1 : 2012 | Identical |
| BS EN ISO 18113-1:2009 | Identical |
| UNE-EN ISO 18113-1:2010 | Identical |
| 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 |
| ONORM 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) |
| ONORM 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) |
| 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 |
| ONORM 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) |
| 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 |
| 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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