GB 17022-1997 Quality assessment standard for on-site semi-quantitative detection kits of salt iodine

This standard specifies the indicators for the evaluation of the on-site semi-quantitative detection kit of salt iodine and its detection quality. This standard is applicable to the production, sales, technical supervision and application departments of the on-site semi-quantitative detection kit of salt iodine. GB 17022-1997 Quality Evaluation Standard for On-site Semi-quantitative Detection Kit of Salt Iodine GB17022-1997 Standard Download Decompression Password: www.bzxz.net

(GB170221997
Quality Assessment Standard for On-site Semi-quantitative Detection Kits for Iodine in Salt Preface
This standard is formulated in accordance with the relevant provisions and requirements of the Outline of China's Plan for Eliminating Iodine Deficiency Disorders in 2000 and the Regulations on the Administration of Iodine Fortification of Table Salt to Eliminate the Hazards of Iodine Deficiency issued by the State Council, as well as the National Iodine Deficiency Disorder Prevention and Control Monitoring Program formulated by the Ministry of Health.
Salt iodine on-site semi-quantitative detection kit is the basic detection tool currently used for iodized salt quality monitoring at home and abroad. Accuracy and reliability are crucial. Without a unified quality assessment standard, it is difficult to guarantee the quality of its production and use, which will inevitably affect the effective implementation of iodine deficiency disease prevention and control monitoring. Achieving standardization is an ongoing effort both at home and abroad. During the preparation of this standard, Appendix A of this standard is the appendix of the standard, which fully refers to and draws on the latest knowledge and successful experiences at home and abroad.
This standard is proposed by the Ministry of Health of the People's Republic of China. The drafting unit of this standard: Iodine Deficiency Disorders Research Institute, China Endemic Disease Control and Prevention Research Center. The main drafters of this standard: Lv Jianguo, Liu Ying, Sun Shuqiu, Wei Honglian, and Su Xiaohui. This standard is interpreted by the Chinese Academy of Preventive Medicine, the technical management unit entrusted by the Ministry of Health. 1 Scope
This standard specifies the indicators for the on-site semi-quantitative detection kit of salt iodine and its detection quality assessment. This standard applies to the production, sales, technical supervision and application departments of the on-site semi-quantitative detection kit of salt iodine. 2. Cited standards
The provisions contained in the following standards constitute this standard through reference in the standards. Articles. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards.
GB5461-92 Edible Salt
GB16006-1995 Iodine Deficiency Disorder Elimination Standard
3 Definitions
This standard adopts the following definitions.
3.1 Semi-quantitative test gives the approximate concentration of iodine in salt, such as 10-20 mg/kg, 20-30 mg/kg, or gives a limit value, such as greater than 20 mg/kg, or less than 20 mg/kg, etc. 3.2 Positive test positive test
The iodine content is judged as “unqualified” as positive. 4 Indicators
4.1 Purpose and scope of application of the test package
4.1.1 Specially used for the determination of iodine content of potassium iodate salt, potassium iodide salt, or both. 4.1.2 Specially used for monitoring the quality of iodized salt at wholesale, retail, household and other equivalent levels, or for monitoring the quality of iodized salt in the production process of iodized salt.
4.2 Expression of iodine content determination results
The content is determined based on whether it meets the relevant national regulations. The determination result is “qualified” or “unqualified”. 4.3 Reliability evaluation of test package preparation and testing 4.3.1 The test result of the test package and the quantitative test result are within the range of ±5mg/kg, and the compliance rate of the test package is greater than or equal to 90%.
4.3.2 The misjudgment rate (false positive rate and false negative rate) for qualified and unqualified should be less than 10%. 4.4 Basic composition of the test package
The basic composition of the test package includes:
a) 1~2 bottles of test reagents;
b) 1 bottle of neutralizing reagent (for the detection of alkaline salts); c) 1 special colorimetric plate (or prepared on the label of the reagent bottle); d) 1 instruction manual (or the instructions are stated on the label of the reagent bottle); 4.5 Color scale on the colorimetric plate
For household-level test kits, color indicators for iodine content (in terms of iodine) of 20mg/kg, 10mg/kg and 0mg/kg should be provided: For iodized salt production-level test kits, color indicators for iodine content (in terms of iodine) of 40mg/kg and 30mg/kg should be provided.
4.6 Contents of the instruction manual for the test kit
The instruction manual for the test kit shall at least include:
a) Instructions for use
b) Date of manufacture;
c) Expiration date;
d) Storage conditions;
e) Precautions.
4.7 Expiration date
4.7.1 The validity period of unopened reagents is at least 18 months. 4.7.2 The validity period of opened reagents is at least 3 months. 4.7.3 The validity period of colorimetric plates matching the reagents is at least 18 months. Appendix AbzxZ.net
(Standard Appendix)
Reliability assessment method for on-site semi-quantitative test kit for salt iodineA1 The assessment should be conducted by more than three people using different batches of test kits to measure the same batch of salt samples, and the results should be compared with the results measured by the standard quantitative method.A2 The salt samples used for the assessment should include refined edible salt with different iodine contents and different types (sea and lake salt, well and mine salt).A3 The assessment should be conducted in a single-blind or double-blind manner.A4 The assessment should be conducted once each when the test kit leaves the factory, in the 12th month, and in the 18th month of storage.
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