T/CI 059-2022 Abolished Group standards

T/CI 059-2022 Cyclotron Epithelial Cell Separator (Ceps)

Publish Date: 2022-09-14 Implement Date: 2022-09-14 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/CI 059-2022

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: -

ICS Name: Other medical equipment

Publish Date: 2022-09-14

Implement Date: 2022-09-14

Scope

Scope: This document specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of circulating epithelial cell separators (hereinafter referred to as "the instrument"). This document applies to circulating epithelial cell separators based on microfluidic and immunocapture technologies, combined with matching reagent kits, for the separation and enrichment of circulating epithelial-derived tumor cells in human peripheral blood. Main technical content: 3.1 Recovery: Under the condition of a known input cell number, the total number of cells obtained on the chip plus the number of cells in the waste liquid after instrument operation, expressed as a percentage of the known input cell number. 3.2 Reproducibility: The reproducibility of the results obtained by repeated measurements using the same reference sample. 3.3 Coefficient of Variation (CV): Another statistical quantity that measures the degree of variation in the observed values of the data. When comparing the degree of variation of two or more sets of data, if the unit and the average value are the same, the standard deviation can be directly used for comparison. If the unit and/or the average value are different, the comparison of the degree of variation cannot use the standard deviation, but needs to use the ratio of the standard deviation to the average value (relative value) for comparison. The ratio of the standard deviation to the average value is called the coefficient of variation, denoted as CV. The coefficient of variation can eliminate the influence of different units and/or average values on the comparison of the degree of variation of two or more sets of data. 4 Requirements 4.1 Normal Operating Conditions The normal operating conditions of the instrument should meet the following requirements: a) Indoor use; b) Altitude: not exceeding 2,000 m; c) Environmental temperature: 5 ℃～40 ℃; d) Environmental humidity under different t