YY/T 1182-2020: Nucleic acids amplification test reagents (kits)

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Scope

This Standard specifies the terms and definitions, classification technical
requirements, test methods, labels and instructions, packaging, transportation
and storage of nucleic acids amplification test reagents (kits) [hereinafter
referred to as "reagents (kits)"].
This Standard applies to the quality control of nucleic acids amplification test
reagents (kits). Nucleic acids amplification methods include polymerase chain
reaction (PCR) technology and isothermal nucleic acid amplification technology.
This Standard does not apply to the following products:
a) reagents (kits) for blood source screening;
b) reagents (kits) for gene sequencing.
This Standard is a general standard for nucleic acids amplification test reagents
(kits). For products or reagents (kits) with special standards, corresponding
product standards or technical requirements should be formulated according to
product characteristics and special standard requirements.

Basic Data

Standard ID	YY/T 1182-2020 (YY/T1182-2020)
Description (Translated English)	Nucleic acids amplification test reagents (kits)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	10,124
Date of Issue	2020
Date of Implementation	2021-01-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the terms and definitions, technical requirements for classification, test methods, labels and instructions for use, packaging, transportation and storage of nucleic acid amplification detection reagents (kits). This standard applies to the quality control of nucleic acid amplification detection reagents (kits). Nucleic acid amplification methods include polymerase chain reaction (PCR) technology and isothermal nucleic acid amplification technology. This standard does not apply to the following products: reagents (kits) for blood source screening; reagents (kits) for gene sequencing. This standard is a general standard for reagents (kits) for nucleic acid amplification detection. For products or reagents (kits) that have special standards, corresponding product standards or technical requirements should be formulated based on product characteristics and special standard requirements.