SF/T 0069-2020 in English
VALIDSpecification for the management of forensic biology identification laboratory
- Issued on:2020-05-29
- Implemented on:2020-05-29
- File Format:PDF
- Delivery:Via email within 1~3 business days
$185.00
本标准规定了法医物证鉴定实验室管理的基本要求以及人员管理、样本管理、设备管理、质量管理、记录管理、方法管理、文书管理、安全管理和环境管理等要求。
本标准适用于在我国司法行政主管部门登记的法医物证鉴定实验室的建设、管理、运行和检查。
Introduction
Standard Framework and Technology Evolution
As the first management specification for forensic evidence identification laboratories in the judicial administration industry, this standard integrates the ISO 17025 laboratory accreditation criteria and special requirements for judicial identification. Compared with the 2013 version of the "Criteria for Accreditation and Review of Judicial Identification Institutions", 12 new technical innovation requirements have been added, including LIMS system management and double verification of STR test kits.
Comparative Analysis of Core Elements
| Management Dimensions | Requirements of this Standard | Differences from CNAS-CL08 |
|---|---|---|
| Sample Chain of Custody | Requires recording of the entire process of transportation/receiving/disposal | Only requires traceability |
| Pollution Prevention and Control | Establishment of a Personnel STR Screening Database is mandatory | No clear regulations |
| Equipment Verification | Requires recording of software version and 10 parameters | Only requires basic calibration |
Key Technology Implementation Points
STR Detection Dual Kit Verification
Standard 7.2c requires the use of STR kits from different manufacturers. In actual applications, the following are recommended:
- Main kit: Select the PowerPlex® Fusion system covering 23 STR loci
- Verification kit: Select the GlobalFiler® kit containing Y-STR
- Threshold setting: Allele peak height ratio <60% requires retesting
Laboratory Zoning Management Specifications
The 7 functional areas specified in Article 12.1 of the standard must meet the following requirements:
| Area | Pressure difference requirements | Temperature and humidity range |
|---|---|---|
| PCR amplification area | Negative pressure 10Pa | 18-25℃/30-60%RH |
| DNA extraction area | Positive pressure 5Pa | 20-28℃/≤70%RH |
Compliance construction suggestions
- Document system: Establish four levels of documents (manuals/procedures/operating instructions/records)
- Staff training: No less than 40 hours of professional and technical training per year
- Proficiency verification: Participate in the annual comparison organized by ISTP or ENFSI

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