YY/T 1789.1-2021 Active Industry standards-Medicine

YY/T 1789.1-2021 In vitro diagnostic test systems—Performance evaluation method—Part 1:Precision

Publish Date: 2021-09-06 Implement Date: 2023-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1789.1-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2021-09-06

Implement Date: 2023-03-01

Pages: 26 pages

Scope

This part of YY/T 1789 specifies the evaluation method for the precision performance of in vitro diagnostic test systems.
This part is applicable to manufacturers conducting precision evaluations of in vitro diagnostic test systems for quantitative testing.
This part is not applicable to the performance evaluation of in vitro diagnostic test systems with results reported on a nominal scale and an ordinal scale, such as those used for blood cell identification, microbial typing, nucleic acid sequence identification, and urinary particle identification, where the results are reported as negative, positive, or 1+, 2+, 3+.
This part is not applicable to precision performance verification in medical laboratories, nor to product type testing.