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YYT1182-2020

Chinese Standard: 'YYT1182-2020'
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YY/T 1182-2020English170 Add to Cart 0--15 minutes. Auto immediate delivery. Nucleic acids amplification test reagents(kits) Valid YY/T 1182-2020
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YY/T 1182-2020
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Replacing YY/T 1182-2010
Nucleic acids amplification test reagents (kits)
核酸扩增检测用试剂(盒)
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JANUARY 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 5 
4 Classification ... 6 
5 Technical requirements ... 7 
6 Test method ... 12 
7 Labels and instructions ... 15 
8 Packaging, transportation and storage ... 15 
References ... 16 
Nucleic acids amplification test reagents (kits)
1 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.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies 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
GB/T 29791.2, In vitro diagnostic medical devices - Information supplied by
the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for
professional use
3 Terms and definitions
The following terms and definitions are applicable to this document.
b) According to the principle of nucleic acid amplification, it can be divided
into: variable temperature amplification detection kit and isothermal
amplification detection kit;
c) Classify according to methodologies; examples of common methodologies:
PCR-fluorescent probe method, PCR-fluorescent dye method, PCR-
melting curve method, multiple fluorescence PCR method, RT-PCR
fluorescence method, nested-PCR method, gap-PCR method, loop-
mediated constant temperature amplification method.
5 Technical requirements
5.1 General requirements
5.1.1 Appearance
The reagents (kits) shall meet the appearance requirements that are specified
by the manufacturer; the appearance requirements include but are not limited
to the following: the reagents (kits) shall have complete components; the
package shall be clean, free from leakage and damage; the signs and labels
shall be clearly written.
5.1.2 Nucleic acid extraction function
The nucleic acid extraction function shall meet the following requirements:
a) For reagents (kits) that contain nucleic acid extraction components, the
manufacturer shall make appropriate requirements for nucleic acid
extraction, and verify the nucleic acid extraction function. For example:
fully consider the interference factors in the sample extraction process and
the possible impact on the subsequent sample amplification process;
b) For reagents (kits) for which samples need to be extracted, but do not
contain nucleic acid extraction components, the manufacturer shall state
or specify the extraction reagents (kits) and provide verification or
confirmation information;
c) For reagents (kits) which are directly amplified without sample extraction,
the manufacturer shall be able to provide sufficient evidence to prove the
anti-interference of the enzymes in its products.
5.1.3 Internal standard and (or) control
Manufacturers shall establish appropriate quality control procedures for the
detection results of reagents (kits); they should reasonably set internal standard
and (or) control in the reaction system according to the characteristics of their
5.2.......
Related standard:   YY/T 1656-2020  YY/T 1667-2020
   
 
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