YY/T 0638-2008In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (English PDF)

1 Scope

This standard specifies ensure calibrators and measurement of controlled substances assigned enzymatic concentration methodological traceability. These calibrators and controls

Substance is expected to be used to establish or verify the accuracy of measuring the concentration of enzyme catalysis, provided by the manufacturer, as part of in vitro diagnostic medical device or

In combination therewith.

This standard does not apply to.

a) the reference measurement procedures designed or selected requirements;

b) the amount of enzyme or enzyme immunoassay of quality involved;

c) no assignment is only used to evaluate the precision of the measurement program, namely the repeatability or reproducibility of controlled substances (precision control materials);

d) controlled substances intended for internal quality control, the results of such substances acceptable range of values has recommended this interval by different

Laboratory measurement procedures for the agreement to establish a provision, which limits non-metrological traceability;

e) the results of the conventional measurement products calibrator traceability of its relationship with the medical judgment of the limit;

f) nominal and ordinal scale related features.

2 Normative references

The following documents contain provisions which, through reference in this standard, constitute provisions of the standard. For dated references, subsequently

Some amendments or revisions do not apply to this standard, however, whether these files can be used to encourage the parties in accordance with this standard agreement

The latest version. For undated reference documents, the latest versions apply to this standard (including amendments).

GB/T 21415-2008 vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrology

Traceability (ISO 17511.2003, IDT)

International Fundamentals and vocabulary generic term measurement (VIM), 2nd edition, Geneva. ISO , 19931)

Guide to the Expression of Uncertainty in Measurement, first edition, Geneva. ISO , 19932) 3)

1) In this standard abbreviations VIM.1993.

2) This publication is a joint working group of experts established by the agency assigned the following. BIMP International Bureau of Weights and Measures, IEC International Electrotechnical Commission,

IFCC International Federation of Clinical Chemistry and Laboratory Medicine, ISO International Standards Organization, IUPAC International Union Pure and Applied Chemistry, IUPAP International Li

Theory and Applications of Physics, OIML International Organization of Legal Metrology.

3) the use of abbreviations in this standard GUM.1993.

3 Terms and Definitions

The following terms and definitions apply to this standard.