Manufacturing of reference materials and reference materials
The measures for the management of reference materials were issued by the State Bureau of Metrology on July 10, 1987, and the specific provisions are as follows:
Article 1 These Measures are formulated in accordance with the provisions of Articles 61 and 63 of the Detailed Rules for the Implementation of the Metrology Law of the People's Republic of China.
Article 2 The reference materials to which these Measures apply refer to the reference materials used for uniform quantities. The reference materials used for uniform quantities include chemical composition, analytical reference materials, physical and physicochemical properties measurement reference materials, and engineering technical properties measurement reference materials.
Article 3 The manufacture of reference materials supplied to foreign entities, as well as the sale and distribution of reference materials, must comply with these Measures.
Article 4: Enterprises and institutions manufacturing reference materials must have facilities, personnel, and analytical measuring instruments and equipment that are compatible with the reference materials they manufacture, and apply to the metrology administrative department of the State Council for the "Manufacturing Measurement Instrument License". Purchasing reference materials can be found on the National Standard Products Network.
Fifth, enterprises and institutions manufacturing new standard material products shall conduct grading appraisal and obtain a standard material grading certificate after review.
Article 6 Conditions for grading of reference materials:
2. The accuracy is at the highest level in China, and the uniformity is within the accuracy range.
3. Stability for more than one year or reaching the international advanced level of similar reference materials.
4. The packaging form meets the requirements of the technical specifications for reference materials.
(2) 1. Valuation by the method of comparison and measurement with the first-class reference material or the method of setting the value of the first-class reference material;
2. The accuracy and uniformity do not reach the level of first-class reference materials, but they can meet the needs of general measurement.
3. The stability is more than half a year, or it can meet the needs of actual measurement.
4. The packaging form meets the requirements of the technical specifications for reference materials.
Article 7 Units applying for the "Manufacturing Measuring Instrument License" and the grading certificate shall fill in the application form and submit three copies of the standard material samples and the following materials to the metrology administrative department of the State Council:
(1) The status of production facilities, technical personnel, and analytical measuring equipment and laboratory conditions:
(2) Development plan mission statement;
(3) Development report, including preparation method, preparation process, stability inspection, uniformity test, measurement method of fixed value, measurement results and data processing, etc.
(4) Comparison of the main characteristics of the same reference material at home and abroad;
(5) Trial report;
(6) the model of the standard material product inspection certificate;
(7) the supply capacity and measures required to ensure uniform value.
Article 8 The metrology administrative department of the State Council shall employ experts from relevant competent departments and relevant units to form a standard material technical review organization, which shall be responsible for the assessment of the application for the "Manufacturing Metrology Apparatus License" and the review of the grading appraisal of standard materials. The grading appraisal shall be classified by the metrology administrative department of the State Council according to the specialty of standard materials, and authorized the technical institutions or statutory metrological verification institutions of the relevant competent departments to be responsible for it. The articles of association and working procedures of the standard material technical review organization shall be organized and formulated by the metrology administrative department of the State Council
Article 9 After the review by the standard material technical review organization, the metrology administrative department of the State Council shall issue the "Manufacturing Measurement Instrument License" and the standard material grading certificate after examination and approval, uniformly stipulate the number, and list it in the standard material catalogue, and publish it to the whole country. If an enterprise or institution fails to obtain the "Manufacturing Measurement Instrument License" and the standard material grading certificate, the relevant competent department shall not approve it to be put into production.
Article 10 If the application for grading and appraisal of reference materials fails the review, the applicant may be allowed to conduct another appraisal and appraisal after improvement. If the appraisal and appraisal have not passed the second time, the applicant shall go through the application formalities again after improvement.
Article 11: Enterprises and institutions manufacturing reference materials must conduct value-setting and uniformity inspections for each batch of reference materials manufactured repeatedly, and issue a standard material product inspection certificate to ensure that their technical indicators are not lower than the original grading requirements.
Article 12 Enterprises and institutions that have obtained the "License for Manufacturing Measuring Instruments" to manufacture standard substances and plan to stop supplying them shall report to the metrology administrative department of the State Council six months ago. Without approval, the supply shall not be stopped without authorization.
Article 13: For reference materials that are backward in technical indicators and do not meet the needs of the state, the metrology administrative department of the State Council may decide to downgrade or abolish them, and replace or revoke the "Manufacturing Measuring Instrument License", the standard material grading certificate and number accordingly.
Article 14 An enterprise or institution that has not obtained the License for Manufacturing Measuring Instruments and the Certificate for Classification of Reference Materials shall not manufacture reference materials for sale or issuance to foreign entities.
Article 15 No reference material product inspection certificate and number, or reference material exceeding the valid period, shall not be sold or issued to foreign units.
Article 16 The unit responsible for the grading and appraisal of reference materials, as well as the assessment, appraisal and review personnel, must keep the samples and technologies provided by the applicant unit confidential.
Article 17 The metrology administrative department of the State Council is responsible for the management of the national standard material work, and its working body is responsible for accepting applications for the assessment and grading appraisal of the "Manufacturing Measurement Instrument License", handling the issuance procedures, and conducting other relevant organizational work.
18th Article The metrology administrative department of the local people's government at or above the county level shall be responsible for the supervision and inspection of the manufacture and sale of standard substances within its own administrative area. Those who violate the provisions of these Measures shall have the right to determine administrative penalties in accordance with the relevant provisions of the Detailed Rules for the Implementation of the Metrology Law of the People's Republic of China.
Article 19 The supervision and administration of the sale of reference materials by foreign investors in China shall be implemented in accordance with the provisions on the import of measuring instruments formulated by the metrology administrative department of the State Council.
Article 20 The forms of applications, grading certificates, numbering methods and technical specifications related to these Measures shall be uniformly formulated by the metrology administrative department of the State Council.
Article 21: To apply for the "Manufacturing Measuring Instrument License" and grading appraisal, fees shall be paid as required.
Article 22 The metrology administrative department of the State Council shall be responsible for the interpretation of these measures.
Article 23 These Measures shall come into force as of the date of promulgation. Where there is any conflict between the previously issued measures for the management of reference materials and these measures, these measures shall prevail.
