GB/T 12715-1991
Abolished
T/XMSA 001-2023
Active
Group standards
T/XMSA 001-2023 The Standard Specification for the Construction of a Basic Sample Library of Healthy Human Intestinal Bacteria
T/XMSA 001-2023 The Standard Specification for the Construction of a Basic Sample Library of Healthy Human Intestinal Bacteria
Price:
$ 20.00
Basic Information
Standard Code:
T/XMSA 001-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Biology, botany, and zoology
Publish Date:
2023-02-20
Implement Date:
2023-02-28
Scope
Scope: This document specifies the terms and definitions for the basic construction of a biological sample bank of healthy human gut microbiota, the basic laboratory requirements for sample bank construction, basic equipment requirements, basic quality management norms, safety management norms, and personnel requirements, etc. This document is applicable to the construction of a biological sample bank of healthy human gut microbiota; Main technical content: This document specifies the terms and definitions for the basic construction of a biological sample bank of healthy human gut microbiota. The basic laboratory requirements for sample bank construction include standardized collection, processing, storage, and transportation of fecal biological samples from healthy humans, as well as basic information, questionnaires, evaluation forms, clinical information, examination reports, and informed consent related to these samples, including quality control, information management, and application systems. The basic facility and equipment requirements include a building height of no less than 4m and a total area of no less than 300m2, which must include: sampling rooms, processing rooms, quality inspection rooms, and storage rooms. The processing rooms are divided into functional areas: microbial extraction areas, microbial preparation areas, cleaning and sterilization areas, and corresponding functional auxiliary areas. The processing rooms shall comply with the D-level cleanliness requirements of GB 50457. The biological sample bank shall comply with the requirements of WS 233 for ordinary BSL-2, and obtain the BSL-2 laboratory registration qualification from the local municipal health commission. The following equipment shall be provided: biosafety cabinets, disinfection equipment, fecal collection tanks, fecal analysis pretreatment instruments or microbial extraction systems, centrifuges or microbial purification equipment, canning equipment, weighing equipment, and ul