This standard specifies the determination principle, requirements, test method, signs, instructions, packaging, transport and storage of total bilirubin test kit (Vanadate oxidation method). This standard applies to the quality control of total bilirubin test kit (Vanadate oxidation method). 2 Normative References The following document is indispensable for the application of this document. For dated references, only dated edition applies to this document. For undated references, the latest edition (including all amendments) applies to this document. YY/T 0466.1 Medical Devices. Symbols to Be Used with Medical Device Labels, Labeling and Information to Be Supplied. Part 1. General Requirements
Basic Data
Standard ID
YY/T 1205-2013 (YY/T1205-2013)
Description (Translated English)
Total bilirubin test kit (Vanadate oxidation method)
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,891
Quoted Standard
YY/T 0466.1
Regulation (derived from)
State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies: total bilirubin assay kit (vanadate oxidation method) requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: total bilirubin assay kit (vanadate oxi
