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BS EN 13612:2002

Current
Current

The latest, up-to-date edition.

Performance evaluation of in vitro diagnostic medical devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-27-2003

Publisher

British Standards Institution

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.

This European Standard 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. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with \'design validation\' and \'design changes\' as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.

Committee
CH/212
DevelopmentNote
Supersedes 99/563275 DC. (05/2002)
DocumentType
Standard
Pages
18
PublisherName
British Standards Institution
Status
Current
Supersedes

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
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
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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