YY/T 1597-2017 English PDF

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YY/T 1597-2017: Neonatal phenylalanine testing kit
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1597-2017	199	Add to Cart	3 days	Neonatal phenylalanine testing kit	Valid

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Basic data

Standard ID: YY/T 1597-2017 (YY/T1597-2017)
Description (Translated English): Neonatal phenylalanine testing kit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 10,190
Date of Issue: 2017-12-05
Date of Implementation: 2018-12-01
Issuing agency(ies): State Food and Drug Administration

YY/T 1597-2017: Neonatal phenylalanine testing kit

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Neonatal phenylalanine testing kit ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Neonatal phenylalanine assay kit 2017-12-05 Published 2018-12-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Categories 1 4 Requirements 1 5 test methods 2 6 logo, label, instruction manual 3 7 Packaging, transportation and storage 3 Reference 4

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized. This standard drafting unit. China Food and Drug Control Research Institute, Southern Medical University. The main drafters of this standard. Wang Yumei, Wu Ying Song, Sun Nan, noble first. Neonatal phenylalanine assay kit

1 Scope

This standard specifies the neonatal phenylalanine kit of technical requirements, test methods, identification, labeling, instructions, packaging, transportation and Storage and so on. This standard applies to quantitative detection of neonatal umbilical cord blood or heel filter paper dried blood samples kit, using the technical methods of fluorescence, enzyme Law and so on.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial signs GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS

3 categories

According to the principle of methodology used is divided into. Fluorescence, enzymatic.

4 requirements

4.1 appearance Manufacturers should be based on the packaging characteristics of their products to provide the appropriate appearance requirements. The kit should generally be composed of components, traits, both inside and outside Packaging, labeling and other requirements of clarity. 4.2 linear interval In the 1mg/dL ~ 16mg/dL interval, the correlation coefficient should not be less than 0.9900. 4.3 accuracy Choose one a) Test national standards or certified reference materials (CRM), the relative deviation should not exceed ± 15.0%. b) The calibrated reagent for calibrating the calibrated kit should be tested. The recovery rate should be between 85.0% and 115.0%. 4.4 Specificity Specific samples tested, the test results should not exceed the normal range claimed by the kit. 4.5 blank limit Should not be greater than 1.0mg/dL. ......

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