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YY/T 1422-2016: Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1422-2016 | English | 159 |
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Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)
| Valid |
YY/T 1422-2016
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Basic data | Standard ID | YY/T 1422-2016 (YY/T1422-2016) | | Description (Translated English) | Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,838 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 191; GB/T 21415-2008; YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods and labeling, labeling, instruction manual, packaging, transportation and storage of serum pregnancy-related plasma protein A test kit (quantitative labeling immunoassay). This standard applies to the serum pregnancy-related plasma protein A quantitative detection reagent (box) (quantitative labeling immunoassay) [hereinafter referred to as PAPP-A reagent (box)]. Quantitative labeling immunoassays include enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro) chemiluminescence, and so on. This standard does not apply to: a) various types of colloidal gold marking test paper; b) radioactive isotopes such as ^ 125I labeled various types of radioimmunoassay or immunoassay kits. | YY/T 1422-2016: Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)
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Pregnancy-associated plasma protein A (PAPP-A) in serum test reagent (quantitative labeling experiment immunoassay)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Serum pregnancy-related plasma protein A detection reagent (box)
(Quantitative labeling immunoassay)
Pregnancy-associatedplasmaproteinA (PAPP-A) inserumtestreagent
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Zhengzhou Antu Biological Engineering Co., Ltd., Beijing Yuande Biomedical
Cheng Co., Ltd., Suzhou Xinbo Biotechnology Co., Ltd.
The main drafters of this standard. Wang Ruixia, Shi Xiaoqin, Tang Lei, Tu Xianju.
Serum pregnancy-related plasma protein A detection reagent (box)
(Quantitative labeling immunoassay)
1 Scope
This standard specifies the requirements for serum pregnancy-related plasma protein A detection reagents (cartridges) (quantitative labeling immunoassay), test methods and
Identification, labeling, instruction manual, packaging, transportation and storage.
This standard applies to the serum pregnancy-related plasma protein A quantitative detection reagent (box) (quantitative labeling immunoassay) [hereinafter referred to as
PAPP-A reagent (box)]. Quantitative labeling immunoassays include enzyme-linked immunosorbent assay (ELISA), time-resolved fluoroimmunoassay,
(Electric) chemiluminescence and so on.
This standard does not apply to.
a) various types of colloidal gold marking test paper;
b) Various radioimmunoassay or immunoassay kits labeled with radioisotope such as 125I.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance
The origin of traceability
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should be based on the characteristics of the product packaging to specify the appropriate appearance requirements. Generally should be the composition of the components of the kit, traits; inside and outside packaging, labels
Clear and so on.
a) kit should be complete components, both inside and outside the packaging should be complete, clear label;
b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation).
3.2 traceability
The source, assignment process and measurement of the PAPP-A calibrator used in accordance with GB/T 21415-2008 and the relevant regulations shall be provided
And so on.
3.3 Accuracy
Accuracy should meet one of the following requirements.
a) test with a reference material (CRM) or other recognized reference material that can be used to evaluate the conventional method as a sample.
The relative deviation of the results should not exceed ± 10%;
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