GB/T 5082-1985
Replaced
DB32/T 4007-2021
Active
Jiangsu ProvinceLocal standards
DB32/T 4007-2021 Tumor high-throughput gene sequencing technical specifications
DB32/T 4007-2021 Tumor high-throughput gene sequencing technical specifications
Basic Information
Standard Code:
DB32/T 4007-2021
Standard Type:
Local standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Diagnostic standards for occupational diseases
ICS Name:
Occupational safety and industrial hygiene
Publish Date:
2021-03-04
Implement Date:
2021-04-04
Pages:
16 pages
Scope
This document specifies the applicable population, indicator requirements and conditions, sequencing process, and quality evaluation of tumor high-throughput gene sequencing laboratories.
This document is applicable to high-throughput gene sequencing testing for tumor patients.
Development Information
Referenced Standards
GB 19489-2004 Laboratories—General requirements for biosafety
GB 19489-2008 Laboratories—General requirements for biosafety
GB/T 30989-2014 Technical regulation of high-throughput gene sequencing
医疗机构临床基因扩增管理办法(卫办医政发〔2010〕194号)
医疗器械监督管理条例(国务院令第276号)
医疗器械注册管理办法(国家食品药品监管总局令第4号)
ISO 15189
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