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BS EN 12287:1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials
Available format(s)

Hardcopy , PDF

Superseded date

31-05-2009

Language(s)

English

Published date

15-10-1999

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
   3.1 Primary measurement standard
   3.2 Secondary measurement standard
   3.3 Matrix (of a material system)
   3.4 Matrix effect
   3.5 Commutability of a material
   3.6 Report
4 Classification and naming of reference materials
   4.1 Description of the properties of reference
        materials
   4.2 System
        4.2.1 Function
        4.2.2 Application and authorities
        4.2.3 Hierarchical position of reference
               materials of higher order in the
               reference measurement system
        4.2.4 Identification code(s)
        4.2.5 Reference material characteristics
   4.3 Component(s)
   4.4 Kind-of-quantity (quantity in a general sense)
   4.5 Numerical value
   4.6 Unit of measurement
   4.7 Construction of systematic designations and
        trivial names
   4.8 Trivial names
   Description
   5.1 Elements of a description
   5.2 Warning and safety precautions
   5.3 Introduction
   5.4 Scope
   5.5 Terminology
        5.5.1 General
        5.5.2 Nomenclature
        5.5.3 Trivial names
   5.6 Justification for choice
   5.7 General characteristics
   5.8 Specific characteristics
   5.9 Validation
        5.9.1 Planning of experimental design
        5.9.2 Assessment of homogeneity
        5.9.3 Statistical evaluation of results
        5.9.4 Assessing the stability
        5.9.5 Value assignment
        5.9.6 Value and uncertainty of measurement
               assigned by one measurement procedure
               in one laboratory
        5.9.7 Regional recognition
   5.10 Intended function
   5.11 Instructions for use
        5.11.1 Safety
        5.11.2 General
        5.11.3 Reagents
        5.11.4 Apparatus
        5.11.5 Environment
        5.11.6 Measuring volumes
        5.11.7 Reconstitution of lyophilized reference
               material
        5.11.8 Reference to patented items
   5.12 Supplier
   5.13 Bibliography
   5.14 Annexes
   5.15 Dates of authorization and revision
6 Label
7 Certificate
8 Package insert
Annex A (informative) Materials with properties other than
        quantities
Annex B (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU directives

Defines requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This standard also provides instruction on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate.

Committee
CH/212
DevelopmentNote
Supersedes 96/560838 DC. (08/2005)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
UNI EN 12287 : 2001 Identical
NEN EN 12287 : 1999 Identical
DIN EN 12287:1999-08 Identical
UNE-EN 12287:2000 Identical
NS EN 12287 : 1999 Identical
SN EN 12287 : 1999 Identical
NBN EN 12287 : 1999 Identical
I.S. EN 12287:1999 Identical
NF EN 12287 : 1999 Identical
EN 12287 : 1999 Identical

EN 12286:1998/A1:2000 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
ISO Guide 33:2015 Reference materials Good practice in using reference materials
CLSI NRSCL13 P : 1995 THE REFERENCE SYSTEM FOR THE CLINICAL LABORATORY: CRITERIA FOR DEVELOPMENT AND CREDENTIALING OF METHODS AND MATERIALS FOR HARMONIZATION OF RESULTS
ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
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
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
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation

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