T/XMSA 003-2023 Active Group standards

T/XMSA 003-2023 Healthy human gut microbiota biological sample preparation technical specifications

Publish Date: 2023-02-20 Implement Date: 2023-02-28 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/XMSA 003-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Laboratory medicine

Publish Date: 2023-02-20

Implement Date: 2023-02-28

Scope

Scope: This document specifies the terms and definitions, preparation steps, and standards for the preparation of biological samples of healthy human gut microbiota. This document is applicable to the preparation of samples of healthy human gut microbiota. Main technical content: It stipulates the following reception norms: When receiving the samples, the technicians shall confirm whether the source of the samples is legal, whether the sample information is complete, whether the samples are well sealed, and whether there are any biosafety risks. After confirming that they meet the requirements, they shall receive the samples and register the information. The appearance of the samples shall comply with Levels 3, 4, and 5 of the Bristol Stool Chart, and the sample quantity shall be ≥100g. The samples shall be transferred into the preparation room through the transfer window. Preparation norms: The operating environment for the preparation of biological samples of healthy human gut microbiota shall comply with the requirements of Class D cleanliness in GB 50457. Laboratory access: Laboratory technicians shall strictly follow the procedures for changing shoes, changing clothes, and disinfection in accordance with the "Operating Procedures for Entering and Leaving Clean Laboratories" (Appendix A). Except for the relevant technical personnel involved in sample preparation, no one else shall enter the clean area during sample preparation. Laboratory facility and equipment management: Key equipment such as fecal pretreatment instruments shall have medical device marketing authorization or registration qualifications, and corresponding equipment use procedures shall be formulated. Before conducting experimental preparation operations, it shall be confirmed that the facilities and equipment are maintained and operated normally, and that the calibrated equipment is within the validity period of the calibration, and the calibration results meet the technical requirements. After