ISO 20836:2021 pdf download – Microbiology of the food chain — Polymerase chain reaction (PCR) for the detection of microorganisms — Thermal performance testing of thermal cyclers.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM: 1995) 3? Terms? and? definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at http:// www .electropedia .org/ 3.1 Polymerase chain reaction 3.1.1 polymerase chain reaction PCR enzymatic procedure that allows in vitro amplification of DNA [SOURCE: ISO 22174:2005, 3.4.1] 3.1.2 PCR method test method based on the PCR (3.1.1) technique Note 1 to entry: Examples include, but are not limited to, PCR, quantitative real-time PCR (qPCR), reverse transcription PCR (RT PCR) and reverse transcription quantitative real-time PCR (RT qPCR).
3.4 Temperature measurement 3.4.1 temperature measurement system temperature measurement and data logging instrument 3.4.2 sampling frequency number of samples per second taken from a time-continuous signal to make a time-discrete signal 3.4.3 response time time required for the temperature measurement system (3.4.1), when subjected to a change in temperature, to react to this change 3.4.4 measurement uncertainty parameter associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the quantity intended to be measured [SOURCE: ISO/IEC Guide 98-3:2008, B.2.18, modified — “quantity intended to be measured” and replaced “measurand” and the notes to entry have been deleted.] 3.4.5 performance test test procedure that determines the performance of a thermal cycler (3.2.1) 3.4.6 calibration operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties (3.4.4) provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication Note 1 to entry: Calibration should not be confused with adjustment of a measuring system, nor with auto-check, self-verification test, verification, normalization, installation qualification (IQ), operational qualification (OQ) or performance qualification (PQ).