EN 13612:2002/AC:2002
Current
Current
The latest, up-to-date edition.
PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Amendment of
Published date
18-12-2002
Publisher
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for the performance evaluation
4 Organisation of a performance evaluation study
5 Modifications during the performance evaluation study
6 Re-evaluation
7 Protection and safety of probands
Annex ZA (informative) - Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
Pertains to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing.
| Committee |
TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 13612:2002 | Identical |
| DIN EN 13612:2002-08 | Identical |
| I.S. EN 13612:2002 | Identical |
| GOST R EN 13612 : 2010 | Identical |
| NEN EN 13612 : 2003 | Identical |
| UNI EN 13612 : 2002 | Identical |
| NS EN 13612 : 1ED 2002 | Identical |
| NBN EN 13612 : 2002 COR 2002 | Identical |
| BS EN 13612:2002 | Identical |
| PN EN 13612 : 2006 | Identical |
| SN EN 13612 : 2002 CORR 2003 | Identical |
| NF EN 13612 : 2002 | Identical |
| UNE-EN 13612/AC:2003 | Identical |
| CSA ISO 15197 : 2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 16/30346073 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BIS IS/ISO 15197 : 2013 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| BS EN ISO 20776-2:2007 | Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Evaluation of performance of antimicrobial susceptibility test devices |
| I.S. EN ISO 20776-2:2007 | CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS - SUSCEPTIBILITY TESTING OF INFECTIOUS AGENTS AND EVALUATION OF PERFORMANCE OF ANTIMICROBIAL SUSCEPTIBILITY TEST DEVICES - PART 2: EVALUATION OF PERFORMANCE OF ANTIMICROBIAL SUSCEPTIBILITY TEST DEVICES |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| ISO/TR 18112:2006 | Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer |
| 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) |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| DIN EN ISO 20776-2:2007-09 | Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007) |
| ISO 20776-2:2007 | Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices |
| ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| 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 |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| 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) |
| BS EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| BS EN ISO 15197:2015 | In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
| 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 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| DIN EN ISO 18113-1:2013-01 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| 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 |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
| 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) |
| EN ISO 20776-2:2007 | Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007) |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| CLSI EP11 P : 1996 | UNIFORMITY OF CLAIMS FOR IN VITRO DIAGNOSTIC TESTS |
| CLSI EP13 R : 1ED 95 | LABORATORY STATISTICS - STANDARD DEVIATION |
| CLSI EP5 A : 1ED 99 | EVALUATION OF PRECISION PERFORMANCE OF CLINICAL CHEMISTRY DEVICES |
| EN 12286:1998/A1:2000 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| CLSI C30 A : 1994 | ANCILLARY (BEDSIDE) BLOOD GLUCOSE TESTING IN ACUTE AND CHRONIC CARE FACILITIES |
| CLSI I/LA6 A : 1ED 97 | DETECTION AND QUANTITATION OF RUBELLA IGG ANTIBODY: EVALUATION AND PERFORMANCE CRITERIA FOR MULTIPLE COMPONENT TEST PRODUCTS, SPECIMEN HANDLING, AND USE OF TEST PRODUCTS IN THE CLINICAL LABORATORY |
| CLSI EP15 A : 1ED 2001 | USER DEMONSTRATION OF PERFORMANCE FOR PRECISION AND ACCURACY |
| CLSI EP7 P : 1986 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| EN 12287 : 1999 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS |
| CLSI DI2 A2 : 2ED 93(R1999) | IMMUNOPRECIPITIN ANALYSES: PROCEDURES FOR EVALUATING THE PERFORMANCE OF MATERIALS |
| CLSI EP12 P : 2000 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI I/LA18 A2 : 2ED 2001 | SPECIFICATIONS FOR IMMUNOLOGICAL TESTING FOR INFECTIOUS DISEASES |
| CLSI EP18 P : 1999 | QUALITY MANAGEMENT FOR UNIT-USE TESTING |
| CLSI C28 A2 : 2ED 2000 | HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| CLSI EP14 A : 1ED 2001 | EVALUATION OF MATRIX EFFECTS |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN 928 : 1995 | IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES |
| CLSI C46 A : 1ED 2001 | BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| CLSI I/LA21 A : 1ED 2002 | CLINICAL EVALUATION OF IMMUNOASSAYS |
| CLSI EP10 A : 1998 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS |
| CLSI EP9 A : 1995 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI EP6 P2 : 2ED 2001 | EVALUATION OF THE LINEARITY OF QUANTITATIVE ANALYTICAL METHODS |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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