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www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY/T 1865-2022 English PDF

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YY/T 1865-2022: General technical requirements for BRCA mutation detection kit and database(High-throughput sequencing)
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1865-2022English489 Add to Cart 4 days [Need to translate] General technical requirements for BRCA mutation detection kit and database(High-throughput sequencing) Valid YY/T 1865-2022

Standard similar to YY/T 1865-2022

Basic data

Standard ID YY/T 1865-2022 (YY/T1865-2022)
Description (Translated English) General technical requirements for BRCA mutation detection kit and database(High-throughput sequencing)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Word Count Estimation 22,240
Date of Issue 2022-10-17
Date of Implementation 2023-10-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the kit requirements for BRCA gene mutation detection kits and databases, the data composition of the database, the data specifications of the database, and the data management and interpretation standards of the database. This standard is applicable to the quality control of BRCA gene germline mutation detection kit, BRCA gene mutation detection database and BRCA gene mutation interpretation. This standard does not apply to the detection of BRCA gene somatic mutations and the detection of BRCA gene mutations by the dideoxy method (Sanger).

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