YY/T 1593-2018Growth hormone testing kit (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the scope of application of growth hormone assay kits, normative references, classifications, requirements, test methods, labels, and Instructions, packaging, transportation and storage.

This standard applies to a kit for quantitative determination of growth hormone based on the principle of double antibody sandwich method.

This standard does not apply to semi-quantitative determination of growth hormone agents using colloidal gold or other methods (eg test strips, etc.); use 125I. Radioisotope-labeled various types of growth hormone radioimmunoassay or immunoradioactive kits.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 191 packaging, storage and transportation logo

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labels) Part 2. In vitro diagnostic reagents for professional use Category 3 Different labeling methods can be divided into enzyme labels, (electro) chemiluminescent labels, (time-resolved) fluorescent labels, etc.;

The same can be divided into micro-plate type, tube type, magnetic particles, microspheres and plastic beads, etc.; according to the different operating procedures can be divided into manual methods and instruments Automatic operation method.

4 Requirements