YY/T 1514-2017 PDF English
Price & Delivery
US$90.00 · In stock · Download in 9 secondsYY/T 1514-2017: Detection kit for antibodies to HIV-1 and HIV-2(western blotting)
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid
| Standard ID | USD | BUY PDF | Delivery | Standard Title (Description) | Status |
| YY/T 1514-2017 | 90 | Add to Cart | Auto, 9 seconds. | Detection kit for antibodies to HIV-1 and HIV-2(western blotting) | Valid |
Click to Preview this PDF
YY/T 1514-2017: Detection kit for antibodies to HIV-1 and HIV-2(western blotting)
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1514-2017YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 Detection kit for antibodies to HIV-1 and HIV-2 (western blotting) Issued on: MARCH 28, 2017 Implemented on: APRIL 1, 2018 Issued by. China Food And Drug Administration
Table of Contents
Foreword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Requirements... 4 4 Test method ... 5 5 Marking, labelling and instructions for use ... 6 6 Packaging, transportation and storage ... 6 Bibliography ... 7 Detection kit for antibodies to HIV-1 and HIV-2 (western blotting)1 Scope
This Standard specifies the requirements, test method, marking, labelling, instructions for use, packaging, transportation, storage, etc. of detection kit for antibodies to HIV-1 and HIV-2 (western blotting). This Standard applies to reagents for qualitative detection of antibodies to HIV-1 and HIV-2 using the western blotting method (including the recombinant immunoblotting method), to fix the multicomponent antigens or recombinant expression multicomponent antigens to the different locations of nitrocellulose membrane using the SDS-PAGA method or the direct sample application method, i.e. detection kits for antibodies to HIV-1 and HIV-2 (western blotting).2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this document. GB/T 191, Packaging – Pictorial marking for handling of goods GB/T 29791.2, In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2. In vitro diagnostic reagents for professional use3 Requirements
3.1 Appearance Appearance shall comply with the following requirements. a) all components of kits shall be complete and there is no leakage of liquid; b) packaging labels in Chinese shall be clear without wear. 3.2 Compliance of positive references for antibodies 4.3 Compliance of negative references for antibodies Use national negative references or standardized negative references for testing, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.3. 4.4 Compliance of uncertain references for antibodies Use national uncertain references or standardized uncertain references for testing, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.4. 4.5 Stability Use the following methods. a) validity stability. obtain kits of a certain time within validity, operate as specified in the instructions for use, and the results shall comply with the requirements of 3.5.2; b) thermal stability. place kits aside for a certain time at certain temperature (normally 37°C), operate as specified in the instructions for use, and the results shall comply with the requirements of 3.5.2.5 Marking, labelling and instructions for use
As specified in GB/T 29791.2-2013.6 Packaging, transportation and storage
6.1 Packaging The pictorial marks for packaging, storage and transportation shall be as specified in GB/T 191-2008. The packaging containers shall well sealed and complete without leakage or damage. 6.2 Transportation Kits shall be transported as required by the manufacturer. During the process of transportation, protect them from exposure to damp, heavy loads, direct sunlight, rain and snow and acid-base materials and damage of exterior and interior packaging. 6.3 Storage Kits shall be stored under the conditions specified by the manufacturer. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
