YY/T 1192-2011: Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay)

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Scope

This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation and storage etc. of the human chorionic
gonadotropin quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the quantitative detection of human chorionic gonadotropin
(HCG) reagent (kit) [hereinafter referred as “HCG reagent (kit)”] of the human blood matrix
or other body fluid components, based on the principle of chemiluminescent immunoassay.
It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection
reagent (kit) in the carrier of microplates, pipes, magnetic particles, microbeads and
plastic beads.
This standard does not apply to.
a) The calibrators and quality-control materials of human chorionic gonadotropin that
are intended for separate sale;
b) The biochip that uses chemiluminescent immunoassayas the principle.
2  Normative references
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials

Basic Data

Standard ID	YY/T 1192-2011 (YY/T1192-2011)
Description (Translated English)	Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	9,988
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Quoted Standard	GB/T 21415-2008
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the shock cord human chorionic gonadotropin (HCG) quantitative assay (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the principle of chemiluminescence immunoassay for the quantitative detection of human blood or other body fluids matrix components of human chorionic gonadotropin shock cord (HCG) reagent (box) [The following tube called "HCG reagent (box)"]. Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay reagent (box). This standard does not apply to: a) intended for human chorionic gonadotropin sold separately calibrators and control materials of human chorionic gonadotropin, b) to chemiluminescent immunoassay for the principle of bio-chips.