GB/T 19703-2020In Vitro Diagnostic Medical Devices Measurement of Biological Source Samples Requirements for certified reference materials and supporting document content (English PDF)

1 Scope

This standard specifies the requirements for the content of certified reference materials and supporting documents, so that they can be considered to be consistent with GB/T 21415-2008.

The result is a higher level of metrology. This standard applies to all types of certified reference materials, including primary measurement standards, secondary measurement standards and calibration

Or an internationally agreed calibrator for accuracy control. This standard also provides how to collect data for setting value, and how to express the result of setting value and

Its measurement uncertainty requirements.

This standard is applicable to certified reference materials whose assignment result is differential value or proportional value. Appendix A provides relevant nominal characteristics and order

Amount of information.

This standard does not apply to reference materials that are part of the in vitro diagnostic measurement system, but many elements may help it.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated references, the latest version (including all amendments) applies to this document.

GB/T 21415-2008 Measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices

Academic traceability (ISO 17511.2003, IDT)

ISO 31 (all parts) 1) Quantities and units (Quantities and units)

1) At present, the ISO 31 series of standards have been replaced by the ISO 80000 series of standards and the IEC 80000 series of standards.

ISO 5725-2 Measurement methods and accuracy of results (correctness and precision) Part 2.Repeatability and accuracy of standard measurement methods

The basic method of reproducibility determination [Accuracy(truenessandprecision)ofmeasurementmethodsandresults-

Part 2.Basicmethodforthedeterminationofrepeatabilityandreproducibilityofastandardmeasure- mentmethod]

ISO 18153 In Vitro Diagnostic Medical Device Biological Samples Measurement of Enzyme Catalytic Concentration Assignment in Calibrators and Control Substances

Metrology traceability (Invitrodiagnosticmedicaldevices-Measurementofquantitiesinbiologicalsamples-

Metrologicaltraceabilityofvaluesforcatalyticconcentrationofenzymesassignedcalibratorsandcon- trol)

The content of the ISO Guide31 standard material standard sample certificate and label (Referencematerials-Contentsofcertifi- catesandlabels)

ISO Guide34 Standard Material/Standard Sample Producer Competence Criteria (General requirements for the competenceofreferencematerialproducers)

ISO Guide35 General principles and statistical methods for the determination of standard samples (Referencematerials-Generalandsta- tisticalprinciplesforcertification)

ISO /IEC Guide98-3.2008 Guidelines for the expression of uncertainty in measurement (Guidetotheexpressionofuncertaintyin measurement)(GUM.1995)

ISO /IEC Guide99.2007 Common concepts and related terms (International Metrology Vocabulary Foundation)

GB/T 16886.6 | GB/T 16886.9 | GB/T 19702 | GB/T 16886.2 | […]