YY/T 1233-2014 Active Industry standards-Medicine

YY/T 1233-2014 Cardiac troponin-I(cTnI)quantitative detection reagent(kit)(Chemiluminescent immunoassay)

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1233-2014

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 7 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for quantitative determination reagents (kits) for myocardial troponin I (cTnI) using chemiluminescence immunoassay.
This standard applies to quantitative determination reagents (kits) for human myocardial troponin I (cTnI) based on the principle of chemiluminescence immunoassay, including enzymatic and non-enzymatic chemiluminescence immunoassay reagents (kits) using microwell plates, tubes, magnetic particles, etc. as carriers.
This standard does not apply to the requirements for calibrators and quality control materials in the reagent kits.