YY/T 1194-2011alpha-Amylase test reagent(kit)(continuous-monitoring procedure) (English PDF)
α-淀粉酶测定试剂（盒）（连续监测法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 1194-2011 is the English-translated version of α-淀粉酶测定试剂（盒）（连续监测法）.
YY/T 1194-2011 is the Chinese pharmaceutical industry standard for the alpha-amylase test reagent kit worked by continuous monitoring.
It specifies the terms and definitions, the classification and naming, the technical requirements, the test methods, the labels, the instructions and the rules for packaging, transport and storage, covering the appearance, the blank absorbance, the traceability of the calibrator, the accuracy, the linear range, the precision, the interference and the stability. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 1194-2011
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the alpha-amylase assay reagent (box) terms and definitions, classification and naming, technical requirements, test methods, labels, Brochures, packaging, transportation and storage requirements.
This standard applies to serum, plasma, urine and other body fluids alpha-amylase activity quantitative detection method using continuous monitoring alpha-amylase Assay reagent (kit), including manual reagents and on the semi-automatic biochemical analyzer used.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
YY/T 0316 Medical Devices Risk Management for Medical Device Applications Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Continuous monitoring method
Under optimum conditions the enzyme reaction, multi-point monitoring throughout the course of the enzymatic reaction product or a reaction in the substrate due to changes over time Case, the reaction rate constant period, in the initial reaction rate per unit time of enzyme activity concentration of the enzyme was calculated.
4 Requirements
4.1 Appearance
In line with the provisions of the company's normal appearance requirements.
4.2 Net content
Net content of the liquid reagent to be less than indicated value.
4.3 Reagent blank
4.3.1 Reagent blank absorbance
Blank absorbance should be less than 0.35.
4.3.2 Reagent blank absorbance change rate
With saline as the test sample was added to the reagent, the reagent blank absorbance change rate (deltaA/min) should be no more than 0.002.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
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