YY/T 1231-2014 English PDF (YYT1231-2014)
YY/T 1231-2014 English PDF (YYT1231-2014)
YY/T 1231-2014: Creatinine test reagent kit (Method of sarcosine oxidase)
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Creatinine test reagent kit
(Method of sarcosine oxidase)
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 Requirements ... 4
4 Test Method ... 5
5 Labeling and Instructions for Use ... 8
6 Packaging, Transport and Storage ... 13
Bibliography ... 14
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, Beijing Branch of Hitachi High-Tech (Shanghai) International Trade Co., Ltd., Shanghai Rongsheng Biology Pharmacy Co., Ltd., Merit Choice Bio-Engineering Co., Ltd., and Abbott Trade (Shanghai) Co., Ltd.
The main drafters of this Standard. Wang Jun, Bi Chunlei, Zhang Yongmei, Zhang Zhengqiang, Xu Donghuan, and Wang Xuefeng.
Creatinine Test Reagent Kit
(Method of sarcosine oxidase)
This standard specifies the technical requirements, test method, labeling, instructions for use, packaging, transport and storage of creatinine test reagent (kit) (method of sarcosine oxidase).
This standard applies to the creatinine test reagent (kit) that is used to carry out quantitative determination of the creatinine concentration in serum, plasma and urine with the method of sarcosine oxidase. It includes manual reagent and reagents used in semi-automatic and full-automatic biochemical analyzer.
This standard does not apply to the creatinine test reagent (kit) with picric acid method. This standard does not apply to the dry creatinine 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 3 Requirements
It shall meet the normal appearance requirements specified by the manufacturer. 3.2 Installed capacity
The installed capacity of liquid reagent shall not be less than the labeled amount. 3.3 Absorbance of reagent blank
The absorbance of reagent blank shall be within the range given by the manufacturer. 3.4 Analysis sensitivity
The rate of change in absorbance shall be within the range given by the manufacturer 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 included.
b) Reagent (kit) name. Additional marking information shall be provided if the reagent (kit) can not be identified uniquely based on the name;
c) Batch number. If the reagent (kit) contains the components in different batch number, the batch number of the external packaging shall ensure that the batch number of each component can be traced from the manufacturer's production records; d) Composition, including the quality, volume, volume after re-dissolution and/or test number;
e) Intended use. Brief instructions for the intended use shall be provided if the reagent (kit) name does not reflect the intended use;
f) In vitro diagnostic purpose;
g) Storage and disposal conditions.
— The necessary storage conditions, which can guarantee the steady state of reagents, calibrators and control materials under the unpacking state, shall be provided;
— Other conditions affecting stability shall be specified;
— All other special measures taken in the case of the product disposal shall be specified.
h) Expiration date.
— The expiration date under the storage conditions shall be specified;
— The expiration date shall be expressed in year and month; and in day when applicable;
— If only the year and month are given, the expiration date shall be the last day of radioactive or biological hazards), appropriate words or symbols shall be marked on the external packaging to warn the hazards. The requirements of YY/T 0316 are applicable;
— If the in vitro diagnostic reagent contains human or animal derived substances, the potentially infectious warning shall be given, taking into account the risk caused by infection of infectious material and its content;
— The dangerous conditions caused by improper use, reasonably foreseeable misuse and usage method not recommended by the manufacturer shall be
explicitly stated, when applicable. The requirements of YY/T 0316 are applicable; — The information for safe treatment and disposal of the materials after being used shall be provided, when applicable;
— Explicitly indicate that the reagent (kit) shall be used for one time only, when applicable.
k) Sample collection, handling and storage.
— Special requirements for the sample’s usage, collection, pretreatment, and/or storage conditions shall be specified;
— Special instructions for preparation shall be specified before the samples are collected by patients.
l) Inspection procedure.
— The complete and detailed test procedures which shall be followed shall be provided;
— All the necessary procedures for sample preparation and steps to carry out test and gain the results shall be included;
— The dilution solution shall be provided, when applicable.
m) Control process.
— The enough information to indicate the performance of in vitro diagnostic reagent (kit) and the correct operating methods in accordance with the instructions shall be provided;
— If a clear suggestion for the quality control program is provided, then it shall explain the actions needed to be taken by the user and the requirements.
n) Calculation of test results. Mathematical methods used to calculated the test results shall be explained;
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 Bibliography
1. GB/T 3358.1-2009 Statistics - Vocabulary and symbols - Part 1. General statistical terms and terms used in probability
2. GB/T 19702-2005 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures 3. GB/T 26124-2011 In vitro diagnostic reagent (kit) for clinical chemistry 4. GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the manufacturer(labelling) - Part 1. Terms, definitions and general requirements 5. GB/T 29791.2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2. In vitro diagnostic reagents for professional use 6. WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits - General guideline
7. JJF 1001-2011 General Terms in Metrology and Their Definitions
8. Ye Yingwu. National Clinical Laboratory Procedures, Edition 3, Nanjing. Southeast University Press, 2006
9. International vocabulary of basic and general terms in metrology, 2nd edition, ISO, Geneva, 1993 (VIM 1993).
10. EN 980. 2003 Graphical symbols for use in the labelling of medical devices 11. NCCLS. Evaluation o...