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YY/T 1597-2017: Neonatal phenylalanine testing kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1597-2017 | English | 199 |
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Neonatal phenylalanine testing kit
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YY/T 1597-2017
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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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