I.S. EN ISO 15193:2009
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
Hardcopy , PDF
English
01-01-2009
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Presentation of a reference measurement procedure
4.1 Elements of a reference measurement
procedure
4.2 Warning and safety precautions
4.3 Introduction
4.4 Scope
4.5 Terms, definitions, symbols and abbreviated
terms
4.6 Measurement principle and measurement
method
4.7 Check list
4.8 Reagents and materials
4.9 Apparatus
4.10 Sampling and sample
4.11 Preparation of measuring system and
analytical portion
4.12 Operation of measuring system
4.13 Data processing
4.14 Analytical reliability
4.15 Special cases
4.16 Validation of a reference measurement
procedure
4.17 Reporting
4.18 Quality assurance
4.19 Bibliography
4.20 Dates of authorization and revision
Annex A (informative) - Reference procedures for
properties other than differential and rational
quantities
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directive 98/79
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