WS/T 493-2017 in English

VALID

Guide to the estimation of the measurement uncertainty of reference methods in enzymology reference laboratiories

Issued on:2017-09-06
Implemented on:2018-03-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $610.00
$592.00

Standard No:	WS/T 493-2017
Document status:	VALID
Title in English:	Guide to the estimation of the measurement uncertainty of reference methods in enzymology reference laboratiories
Title in Chinese:	酶学参考实验室参考方法测量不确定度评定指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2017-09-06
Implemented on:	2018-03-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
Related Keywords:	measurement uncertainty combined uncertainty components uncertainty impact spectrophotometer calibration wavelength accuracy±1nm reference methods enzymology reference laboratiories introduction analysis
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本标准规定了酶学参考实验室在运行参考方法时测量不确定度的来源、评定测量不确定度步骤及报告方式。
本标准适用于酶学参考实验室评定参考方法测量酶催化活性浓度的测量不确定度，也适用于采用分光光度原理测量的其他参考方法测量量值的测量不确定度评定，同时可供认可评审员在评审过程中使用。

Introduction

Analysis of the core content of the standard

Key elements	Technical requirements	Uncertainty impact
Spectrophotometer Calibration	Wavelength accuracy±1nm (k=2)	GGT measurement can reach 3.25%/nm
Reaction temperature control	37.0±0.1℃（k=2）	LDH sensitivity coefficient6.8%/℃
Pipette accuracy	Hamilton dispensing instrument 2000μL tolerance 40μL	Triangular distribution standard uncertainty 16.33μL

Classification of sources of measurement uncertainty

1. Pre-measurement stage

Sample processing:Weighing error of lyophilized powder reconstitution (0.28%), LDH cold denaturation effect
Reagent factors:Weighing variation of pyridoxal phosphate, inter-batch difference of diglycine (2.5%)

2. Measurement process

Instrument performance:

Absorbance calibration error (rectangular distribution 0.3%/√3)
Optical path of cuvette (10.00±0.01mm, k=2)

Environmental Control: pH Fluctuation (ALP Sensitivity Coefficient 2.47%/0.03pH)

3. Post-Measurement Phase

Outlier Removal Rules (≤10% of Data Volume), Value Rounding Strategy

Technological Evolution and Implementation Recommendations

Standard Development Background: Based on the IFCC reference method system, this standard addresses key metrological issues in the traceability of enzymatic measurement values. The 2017 edition systematically standardizes the assessment methods for 12 core parameters, including temperature and pH, for the first time.

Operational optimization suggestions:

Use the weighing method to reconstitute freeze-dried quality control products (balance MPE±0.05mg)
Prepare new unstable reagents (such as NADH) for each batch
Perform multi-day precision experiments (≥4 working days)

Note: When the combined uncertainty components exceed 10, it is recommended to use the Monte Carlo method (MCM) for verification

More samples: JGJ 94-2008 DL/T 5154-2012 DL/T 368-2010

Sample only — not a preview of WS/T 493-2017

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