UNI EN ISO 18113-1 : 2012
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
Superseded date
27-09-2024
Superseded by
Published date
19-01-2012
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for information supplied by the
manufacturer
Annex A (informative) - Performance characteristics of IVD
medical devices
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of the EU
Directive 98/79/EC on "in vitro Diagnostic Medical
Devices"
Describes concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 18113-1:2011 | Identical |
| ISO 18113-1:2009 | Identical |
| 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 |
| CLSI C51 P : 1ED 2010 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| 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 |
| 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 |
| 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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