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YY/T 1232-2014 English PDF (YYT1232-2014)

YY/T 1232-2014 English PDF (YYT1232-2014)

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YY/T 1232-2014: Gamma-Glutamyl transpeptadase test reagent kit (Method of GPNA)
This Standard specifies the technical requirements, test method, labeling, instructions for use, packaging, transport and storage of Glutamyl transpeptadase test reagent kit (Method of GPNA). This Standard applies to the glutamyl transpeptadase test reagent (kit) that is used to carry out quantitative determination of the glutamyl transpeptadase activity in serum and plasma, with the method of glutamyl-3-carboxyl-paranitroaniline. It includes manual reagent and reagents used in semi-automatic and full-automatic biochemical analyzer. This Standard does not apply to the dry glutamyl transpeptadase test reagent (kit).
YY/T 1232-2014
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
γ-Glutamyl transpeptadase test reagent kit
(Method of GPNA)
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirement ... 4
4 Test Method ... 6
5 Labeling and Instructions for Use ... 9
6 Packaging, Transport and Storage ... 15
Bibliography ... 17
Foreword
This Standard is drafted according to the rules specified in GB/T 1.1-2009. Please note that some contents in the Document may involve patents. The issuing organization of this Document does not undertake the responsibility of identifying these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC 136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China.
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Shanghai Fosun Long March Medical Science Co., Ltd., InTec Products (Xiamen) Technology Co., Ltd., Beijing Chemclin Biotech Co., Ltd., and Merit Choice Bio-Engineering Co., Ltd.
The main drafters of this Standard. Wang Jun, Wu Jie, Bi Chunlei, Du Jiao, Cheng Yinghao, and Xu Donghuan.
γ-Glutamyl transpeptadase test reagent kit
(Method of GPNA)
1 Scope
This Standard specifies the technical requirements, test method, labeling, instructions for use, packaging, transport and storage of γ-Glutamyl transpeptadase test reagent kit (Method of GPNA).
This Standard applies to the γ-glutamyl transpeptadase test reagent (kit) that is used to carry out quantitative determination of the γ-glutamyl transpeptadase activity in serum and plasma, with the method of L-γ glutamyl-3-carboxyl-paranitroaniline. It includes manual reagent and reagents used in semi-automatic and full-automatic biochemical analyzer. This Standard does not apply to the dry γ-glutamyl transpeptadase test reagent (kit). 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.
GB 3100 The international system of units and its application
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
YY /T 0316 Medical devices - Application of risk management to medical devices YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements YY/T 0638 In Vitro Diagnostic Medical Devices. Measurement of Quantities in Biological Samples. Metrological Traceability of Values Assigned to Enzymatic Concentration of Calibrators and Control Materials
3 Requirement
3.1 Appearance
It shall meet the normal appearance requirements specified by the manufacturer. e) The microbiological status of the product shall be specified when applicable; f) Unless the use of the reagent (kit) is easy and obvious; otherwise it shall provide the instructions for use.
— Corresponding notices or symbol shall be present to prompt the user that it shall read the instructions for use carefully before using the reagent (kit);
— The language used in the instructions for use shall be understood by the expected user.
g) It shall focus on prompting the user of the reagent (kit)’s important changes and the position of related information;
h) Words or symbols shall be used to warn the users about the existing hazards and risks. The requirements of YY/T 0316 are applicable;
i) The name, letter, number, symbol, color and graphics of each component of the reagent (kit) shall be marked in the same way;
j) The instructions for use of the reagent may be in the forms such as leaflet that is inserted into packaging; on the surface of the outer container; in the user's manual; or integrated into the operation manual with the instructions for use of instruments or analysis system; k) The instructions for use of the reagent may be in electronic version; li) Part of the instructions for use may be provided in coded form, and explained in the operation manual of the system;
m) If the detailed instructions for use is not enclosed with the reagent (kit), the manufacturer shall ensure that the users can get the correct version of the instructions for use; n) The labels of external and internal packaging shall include the specified information. The language and/or symbols used shall be easy to understand;
Example. Printing quality, font and font size.
o) The marking, labeling and instructions for use accompanying with the reagent (kit) shall include at least the before-use safe handling and storage.
5.2 Marking and labels of external packaging
The marking and labels of external packaging shall include the following information. a) Manufacturer's name and address;
Note 1. the address may include the province, city, county and town, when applicable; Note 2. the name and address of the authorized representative, distributor or importer may also be a) Manufacturer's name and full address or contact information;
b) Marking and reagent (kit) name. Additional marking information shall be provided if the reagent (kit) can not be identified uniquely based on the name;
c) Intended use. The intended use (including measured amount) and use restrictions shall be described. The medical indications shall also be described, when applicable; d) Principle of measurement procedure. The principle of measurement procedure shall be specified, including the reaction type (such as chemical, microbial, or immunochemical reaction), indicator or monitoring system, and/or other appropriate details; e) Traceability of calibrators and accuracy control materials.
— If applicable, metrological traceability of values assigned to calibrators and control materials shall be specified, including the available reference materials and/or higher level of reference measurement procedures;
Note. GB/T 21415-2008 specifies the traceability requirements for the reference materials and/or reference measurement procedures.
— Relevant scientific document or other available reference measurement procedures or reference material document shall be provided, when applicable.
f) Component. The nature and amount or concentration of reactive components shall be provided. Relevant information of other components affecting measurement procedures shall be provided;
g) Additional equipment required.
— All the special equipment that are not listed by the manufacturer but that are required to ensure the safety and effectiveness of reagent (kit) shall be provided; — Marking information of these equipment and connection methods for normal use shall be provided.
h) Reagent preparation. All preparation steps of the reagent shall be described; i) Storage and service life after the first unpacking.
— If the storage conditions and period of validity after the first packing are different from those which shall be given by the reagent label, they shall be stated in the instructions for use;
— The storage conditions and stability of the working reagent shall be given, when applicable.
j) Warning and preventive measures.
o) Explanation of results.
— The acceptance and rejection criteria of the test results shall be stated. For instance, if a special result is obtained, then it shall indicate whether an additional test is required;
— The meaning of the test results obtained shall be explained.
p) Performance characteristics.
— The characteristics of analysis performance related to the intended use shall be described;
— The characteristics of diagnostic performance related to the intended use shall be described.
q) If applicable, descriptions of the reference interval, reference population, and related references shall be provided;
r) The restrictions of inspection procedure shall be specified, including. — Information of related clinical known interfering substances;
— Information of the tests for known inappropriate samples and the potential consequences;
— Factor and environment that may affect the results; if applicable, the possibility of carrying over contamination.
s) The references shall be given.
6 Packaging, Transport and Storage
6.1 Packaging
The packaging shall meet the following requirements.
a) The reagent (kit) packaging shall be free of natural and mechanical damage; b) If applicable, the operation manual and product certificate shall be enclosed within the packaging.
6.2 Transport
The product shall be transported in accordance with the conditions stipulated in the contract.
6.3 Storage
Bibliography
1. GB/T 3358.1-2009 Statistics - Vocabulary and symbols - Part 1. Genera...
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