2.Varieties systematization and standards status analysis of fermented Chinese medicine.
Ting-Ting FU ; Xing-Bin YIN ; Meng-Ru CAI ; Rong-Yue ZHU ; Hua-Ting HUANG ; Shi-Lang LIAO ; Chang-Hai QU ; Xiao-Xu DONG ; Yue-Hua ZHOU ; Jian NI
China Journal of Chinese Materia Medica 2023;48(10):2699-2712
Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.
Medicine, Chinese Traditional
;
Reference Standards
;
Quality Control
;
Fermentation
3.Analysis and Reflection on Drafting Units of Medical Device Industry Standards in China.
Yun MENG ; Qian DONG ; Shankui RONG ; Shushu SHAO ; Huiwen XU
Chinese Journal of Medical Instrumentation 2023;47(4):433-436
Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
Reference Standards
;
China
;
Industry
4.Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica.
Jing-Yi YANG ; Zhen SANG ; Rui WANG ; Yan-Hong SHI ; Yi-Ran HUANG
Chinese journal of integrative medicine 2023;29(6):540-548
Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
Materia Medica/therapeutic use*
;
Plants, Medicinal
;
Commerce
;
Internationality
;
Medicine, Chinese Traditional
;
Reference Standards
;
Drugs, Chinese Herbal/therapeutic use*
;
China
6.Revision and prospect of the "Standards for Drinking Water Quality (GB5749-2022)" in China.
Chinese Journal of Preventive Medicine 2023;57(6):801-805
The revision of the national standards for drinking water quality is an important, rigorous and delicate endeavor. The paper introduced the revision of this standard, emphasizing the revision principle, overall technical considerations, and revision contents. Recommendations were also proposed for the implementation of this standard.
Humans
;
Drinking Water
;
Water Quality
;
Reference Standards
;
China
;
Water Pollutants, Chemical/analysis*
;
Water Supply
7.Methodological study on the establishment of limit values in the Standards of Drinking Water Quality.
Lan ZHANG ; Xiao Yuan YAO ; Bi Xiong YE ; Jia Yi HAN ; Sheng Hua GAO
Chinese Journal of Preventive Medicine 2023;57(6):839-843
The establishment of limit values for standards of drinking water quality is an important and complex process. This study systematically introduced the methodology of the establishment of standard limit values for drinking water quality and elaborated on the workflow of setting limit values of water quality indicators, principles and methods of selecting water quality indicators, derivation of safety reference values, and establishment of limit values. It also aimed to provide reference and support for the future revision of relevant standards.
Humans
;
Water Supply
;
Drinking Water
;
Reference Standards
;
Water Quality
;
Water Pollutants, Chemical/analysis*
8.Interpretation of Consolidated Health Economic Evaluation Reporting Standards 2022.
Li Yuan TAO ; Ge GAN ; Jue LIU
Chinese Journal of Epidemiology 2023;44(4):667-672
The number of studies related to health economics evaluation is increasing. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) contains 28 items. Based on CHEERS 2013, CHEERS 2022 adds a health economic analysis plan, model sharing, and community, patient, public, and other relevant stakeholders' participation in the statement, taking into account the future development direction of health economics evaluation. It provides a useful review tool for peer reviewers, editors, and readers and supports health technology assessment agencies in establishing standard reporting standards for health economics evaluations. In this study, we briefly introduced and interpreted the CHEERS 2022 statement and analyzed an example of health economics evaluation in infectious disease epidemiology to provide a reference for researchers to report studies regarding health economics evaluation standardly.
Humans
;
Cost-Benefit Analysis
;
Checklist
;
Economics, Medical
;
Reference Standards
;
Research Report
9.Current practices in the harmonisation of autoantibodies test.
Ren Fang ZHOU ; Min HE ; Bin YANG ; Xi LI ; Chao Jun HU
Chinese Journal of Internal Medicine 2023;62(4):356-362
Standardisation and harmonisation of the detection of autoantibodies is important for the clinical application of autoantibodies. However, achieving complete standardisation is difficult and involves several challenges due to the complexity and particularity of autoantibody detection. Harmonisation is feasible and valued, but it involves all aspects and processes of autoantibody detection. Based on the consensus and practice of the clinical application of autoantibody detection in recent years, we discuss harmonisation in this review.
Humans
;
Autoantibodies
;
Reference Standards
10.Analysis of noise reduction measures in a noise workshop handover control room.
Rui Feng DONG ; Qing Dong WU ; Dong Liang CHAI ; Xiang Ming XUE ; Jing Ming ZHAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(5):379-382
Objective: To explore the sound insulation, sound absorption and other noise reduction transformation methods in a noise workshop handover control room. Methods: In December 2021, through the occupational health investigation and on-site testing of the handover control room of a noise workshop, the causes of excessive noise were analyzed, and the transformation design scheme to reduce noise was proposed and the effect was analyzed. Results: Before the transformation, the peak frequency band noise intensity of the noise workshop handover control room was 112.8 dB (A), and the peak frequency was 1000 Hz. After noise reduction, the theoretical calculated control value was 61.0 dB (A), and the measured noise intensity was 59.8 dB (A) . Conclusion: The noise intensity of the handover control room is reduced after noise reduction, which is in line with the contact limit requirements of the control room in GBZ 1-2010 "Hygienic Standards for the Design of Industrial Enterprises", and has reference significance for noise control engineering.
Noise/prevention & control*
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Occupational Health
;
Industry
;
Reference Standards
;
Hygiene
;
Noise, Occupational/prevention & control*


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