I.S. EN 13612:2002
Current
The latest, up-to-date edition.
PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2002
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for the performance evaluation
3.1 Responsibilities and resources
3.2 Documentation
3.3 Final assessment and review
4 Organisation of a performance evaluation study
4.1 Preconditions
4.2 Evaluation plan
4.3 Sites and resources
4.4 Basic design information
4.5 Experimental design
4.6 Performance study records
4.7 Observations and unexpected outcomes
4.8 Evaluation report
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
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 13612:2002 | Equivalent |
| NF EN 13612 : 2002 | Identical |
| BS EN 13612:2002 | Equivalent |
| DIN EN 13612:2002-08 | Identical |
| NEN EN 13612 : 2003 | Identical |
| BS EN 13612:2002 | Equivalent |
| NS EN 13612 : 1ED 2002 | Identical |
| NBN EN 13612 : 2002 COR 2002 | Identical |
| BS EN 13612:2002 | Identical |
| UNE-EN 13612:2002 | Identical |
| 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 |
| 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 |
| 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 |
| 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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