Thoughts on the development of International Organization for Standardization standards for Traditional Chinese Medicine information models / 国际中医中药杂志

The development of the International Organization for Standardization (ISO) standard for Traditional Chinese Medicine (TCM) information model is needed to promote the coordinated development of TCM information research and application on a global scale, and it is of great significance to promote the use of TCM data. Based on the 13 years of experience in the development of the ISO standard for the TCM information model, we introduced and discussed the development background, development platform, internationality and classification of the standard development. We determined the necessity of the ISO standard of TCM information model to be independent of modern medical information model standard, the necessity of developing standards on a large scientific platform, and the necessity of health informatics experts participating in standard development. We summarized the main points of international and domestic coordination. We emphasized the balance between the overall layout and new areas development, and the importance of application and promotion.

In vitro hydrodynamic performance testing of heart valve prosthesis and its clinical application / 中国胸心血管外科临床杂志

@#The heart valve prosthesis must have excellent hydrodynamic performance which is usually tested in vitro, not in vivo. This paper comprehensively introduced the principles and methods of hydrodynamic performance in vitro testing, helping clinicians to understand valve performance parameters, evaluate valve applicability, and reduce clinical risk of the valve prosthesis. In vitro testing not only serves as the "gold standard" for valve prosthesis assessment, but also provides detailed data for design and optimization of the prosthesis. ISO 5840 defines the items and methods for valve in vitro testing, which consists of three parts: (1) pulsatile flow testing, which reproduces the pulsating flow of the valve prosthesis after implantation in the human body; (2) steady flow testing, which assesses valve forward flow resistance; (3) durability testing, which evaluates the durability of the valve prosthesis and determines the expected failure   mode. In addition, the paper presented the differences between atrioventricular and aortic valve testing, the method of mitral valve testing, the differences between transcatheter and surgical valve testing, and the method of valve flow visualization.

A contrastive analysis on the international standard terminologies of tongue manifestation between WHO version and ISO TC249 version / 国际中医中药杂志

The paper takes the shared terms of tongue manifestations in the book World Health Organization International Standard Terminologies on Traditional Medicine in the Western Pacific Region.2007 and ISO 23961-1:2021 Traditional Chinese medicine-Vocabulary for diagnostics-Part 1:Tongue,as the basic contrastive analysis corpus, and. makes Diagnostics of Traditional Chinese Medicine edited by Zhu Wenfeng and the eighth edition of Oxford Advanced English-Chinese Dictionary as reference books . Based on the translation theory of "Adaptation" and "Selection", the main characteristics of the terminology standards of tongue manifestation in the two versions are analyzed and summarized from the dimension of language, culture and communication. And then, problems such as selection of terms, difference of term property and structure, single choices of term-selection standard for compound tongue manifestations, different contexts for the same term and a lack of certain terminologies are found. Thus, this paper finds that to achieve different communicative effects in the context, the differences of the applicable objects of terms should be considered. These findings suggest that terms of WHO serve as the tool of education and training, targeting practitioner as main user, while terms of ISO serve as information objectivization, aiming to specify data exchange for diagnostic instrument.

Analysis of the results of international demand survey on / 中国针灸

The survey is conducted prior to the development of international standard,

Establishment of quality management system of Organ Procurement Organization with Chinese characteristics / 器官移植

Quality assurance is the responsibility of Organ Procurement Organization (OPO). The establishment of OPO quality management system is a novel task for implementing high-quality human organ donation. At present, the quality management of OPO still has certain problems, such as lack of comprehensive management organization, standardized management process, scientific evaluation index, qualified professionals and strong safety culture atmosphere, etc. It is necessary to deliver top-level design from three perspectives of ideological concept change, quality management system construction and process implementation management in combination with the actual situation of OPO and reference to the criteria of international general quality management system. More importantly, the managers of OPO should play a leading role in ensuring the efficient operation of OPO in the persistent improvement of quality management system.

Analysis on international demand investigation for technical specification of acupuncture- moxibustionthe and its general rules of drafting / 中国针灸

The electronic questionnaire was adopted to survey the international demand on

Cost minimization analysis of an in-house molecular test for cytomegalovirus in relation to a commercial molecular system

ABSTRACT Introduction: Cytomegalovirus may cause severe disease in immunocompromised patients. Nowadays, quantitative polymerase chain reaction is the gold-standard for both diagnosis and monitoring of cytomegalovirus infection. Most of these assays use cytomegalovirus automated molecular kits which are expensive and therefore not an option for small laboratories, particularly in the developing world. Objective: This study aimed to optimize and validate an in-house cytomegalovirus quantitative polymerase chain reaction test calibrated using the World Health Organization Standards, and to perform a cost-minimization analysis, in comparison to a commercial cytomegalovirus quantitative polymerase chain reaction test. Study design: The methodology consisted of determining: optimization, analytical sensitivity, analytical specificity, precision, curve variability analysis, and inter-laboratorial reproducibility. Patients (n = 30) with known results for cytomegalovirus tested with m2000 RealTime System (Abbott Laboratories, BR) were tested with the in-house assay, as well as patients infected with other human herpes virus, in addition to BK virus. A cost-minimization analysis was performed, from a perspective of the laboratory, assuming diagnostic equivalence of the methodologies applied in the study. Results: The in-house assay had a limit of detection and quantification of 60.3 IU/mL, with no cross-reactivity with the other viral agents tested. Moreover, the test was precise and had a R 2 of 0.954 when compared with the m2000 equipment. The cost analysis showed that the assay was economically advantageous costing a median value of 37.8% and 82.2% in comparison to the molecular test in use at the hospital and the m2000 equipment, respectively. Conclusions: These results demonstrated that in-house quantitative polymerase chain reaction testing is an attractive alternative in comparison to automated molecular platforms, being considerably less expensive and as efficacious as the commercial methods.

Transformation of the domestic standard ( / 中国针灸

Through analyzing the differences in the clinical questions of

Design and application of quality standard of Dao-di herbs / 中国中药杂志

Dao-di herbs, which are widely recognized as medicinal materials with a high quality and good efficacy in clinic, are now facing the dilemma of absence of standard. This study focused on a pivotal scientific problem of design and application of quality standard of Dao-di herbs, and systematically illustrated the general rules for the quality standard of Dao-di herbs involving "four rules, six core contents, and three key methods". The quality standard of Dao-di herbs shall be fully based on literatures as well as habitat, planting/breeding, processing, characters, chemical-pharmacological/toxic data. The common requirements for the quality standard of Dao-di herbs contain "clear source, explicit origin, rational indicator, gradable quality, and multiple detection methods". Notably, traditional experiences and modern techniques, quality tracing management system, "quality determination by distinguishing characters" method, rapid detection technology, effective/toxic substances control method, were comprehensively applied in this standard to purse the objectification, automation, and intellectualization of detection technology. Appearance characters, chemical components, and bioactive parameters, unified effective/toxic indicators, quality markers, and pharmacopeial control indicators and reasonable ranges were included in rigorous quality standards for Dao-di herbs. Besides, simple grading method shall be developed to guide the implementation of "high quality-high price" policy. Eventually, the new quality standards for Dao-di herbs will lead international standards and promote the high-quality development of Dao-di herbs.

New Process of International Standardization of Wheelchair / 中国康复理论与实践

This article introduced the history of International Organization for Standardization(ISO)and the procedure to formu-late international standard,especially the classification of wheelchair and ISO Wheelchair Technical Committee.There are 37 ISO standards on wheelchair published,and other seven ones are being modified.The implication for develop-ment of standards on wheelchair in our contry was also discussed.

Design of Rehabilitation Therapy Practice Base Using International Standards / 中国康复理论与实践

@#Objective To focus on how to bring the international teaching methods, assessment methods and indicators of the rehabilitation clinical practice on the basis of the local conditions.Methods By analyzing the problems found in the years of clinical teaching, and combining with research status home and abroad, the clinical teaching standards of WCPT were analyzed, and the design of establishing international standard rehabilitation practical base in local area was proposed. This paper discussed and shared our learning and suggestion in practice.Results This paper solved a series of issues of this clinical practical base, such as positioning, training methods and assess, and broke the traditional teaching mode of emphasizing pedagogical part.Conclusion It is very important to strengthen the skills training, improve the assessment system, and establish multiple assessment ways to clinical skills.

Interpretation of the International Standard 2017 Version of Implantable Neurostimulators / 中国医疗器械杂志

ISO 14708-3 "Implants for surgery-active implantable medical devices-Part 3:implantable neurostimulators" 2017 version and 2008 version are compared, and changes in the standard are interpreted combined with the characteristics of the neurostimulator. The new version of the standard for the first time in the introduction mentioned a new type of non-electrode or extension's neurostimulator. Key issues that have significant impact on safety concerns such as wireless charging temperature rise, MRI acceptance criteria, etc., are given for the first time in the new version. New requirements to the wireless communication section are added, and the electromagnetic compatibility part is greatly adjusted. With more miniature non-electrode or extension's neurostimulator entering the market, standards such as electromagnetic compatibility and MRI, there will be greater adjustments.

Comparative study on quality of scanned images from varying materials and surface conditions of standardized model for dental scanner evaluation

PURPOSE: The purpose of this study is to evaluate the image acquisition ability of intraoral scanners by analyzing the comprehensiveness of scanned images from standardized model, and to identify problems of the model. MATERIALS AND METHODS: Cast models and 3D-printed models were prepared according to international standards set by ISO12836 and ANSI/ADA no. 132, which were then scanned by model scanner and two different intraoral scanners (TRIOS3 and CS3500). The image acquisition performance of the scanners was classified into three grades, and the study was repeated with varying surface conditions of the models. RESULTS: Model scanner produced the most accurate images in all models. Meanwhile, CS3500 showed good image reproducibility for angled structures and TRIOS3 showed good image reproducibility for rounded structures. As for model ingredients, improved plaster model best reproduced scan images regardless of the type of scanner used. When limited to 3D-printed model, powdered surface condition resulted in higher image quality. CONCLUSION: When scanning structures beyond FOV (field of view) in standardized models (following ISO12836 and ANSI/ADA 132), lack of reference points to help distinguish different faces confuses the scanning and matching process, resulting in inaccurate display of images. These results imply the need to develop a new standard model not confined to simple pattern repetition and symmetric structure.

Variaciones de la Razón Normalizada Internacional en pacientes con prótesis valvulares complicados / Variations of the International Standard Ratio in complicated patients with valve prosthesis

Se llevó a cabo un estudio observacional, descriptivo y transversal de 51 pacientes portadores de prótesis valvulares, ingresados en el Cardiocentro del Hospital Provincial Docente Clinicoquirúrgico Saturnino Lora Torres de Santiago de Cuba por presentar trombosis valvular o episodios hemorrágicos, desde enero del 2012 hasta diciembre del 2014, a fin de estimar las variaciones en los valores de la Razón Normalizada Internacional y su asociación con estos eventos. Se aplicó la prueba de Ji al cuadrado. Preponderaron los afectados con trombosis valvular (60,4 por ciento) y Razón Normalizada Internacional menor de 2,5; mientras que esta última en las hemorragias fue superior a 3,5. Aquellos con más de un factor de riesgo asociado presentaron mayor cantidad de episodios trombóticos; eventos que tuvieron menor incidencia cuando se integraron warfarina y aspirina al tratamiento

An observational, descriptive and cross-sectional study of 51 patients with valve prosthesis was carried out. They were admitted to the Cardiology Center of Saturnino Lora Torres Teaching Clinical Surgical Provincial Hospital due to valve thrombosis or bleeding episodes, from January, 2012 to December, 2014, with the purpose of estimating the variations in the International Standard Ratio values and their association with these events. The chi-square test was carried out. Those patients affected with valve thrombosis (60.4 percent) and International Standard Ratio under 2.5 were predominant; while the latter in bleedings was over 3.5. The patients with more than one associated risk factor presented higher quantity of thrombosis episodes; events that had less incidence when warfarin and aspirin were included in the treatment

Differences and international standardization between acupuncture as therapy and as specialty / 中国针灸

The purpose of this study is to explore the differences of definition and clinical roles as well as international standardization between acupuncture as therapy and as specialty, which can provide reference evidence for specialization and internationalization of acupuncture. Owing to the clinical efficacy and safety, the credibility and controversy both exist in acupuncture; moreover, there is a lack of fair definition and international precedent regarding acupuncture specialty. Therefore, it is particularly essential to objectively compare the differences of definitions and clinical roles as well as criteria of international standardization for acupuncture as therapy and as specialty. It is believed acupuncture standardization can draw lessons from the international medical standards, evidence-based medicine and acupuncture theory from the following three major projects:acupuncture safety and contraindications; acupuncture indications and treatment guidelines; acupuncture indication classified into 3 levels of evidence-based acupuncture disease spectrum, as objective evidence of indication of acupuncture specialty.

Comparison of national standard GB/T 31774 and international standard ISO 18668 for Chinese medicines coding system / 中国中药杂志

Coding rules for Chinese medicines and their codes (GB/T 31774-2015) was issued by General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (AQSIQ) and Standardization Administration of the People's Republic of China (SAC) in 2015. Coding system for Chinese medicines (ISO 18668-1, 2, 3 and 4) series were issued one after another by International Organization for Standardization in 2016 and 2017. In this paper, the comparative study on the GB/T 31774 and ISO 18668-1, 2, 3 to 4 would be conducted to expound the similarities and differences among them. This essay aims at promoting the application of national and international standards of coding system in production and operation enterprises and the medical institutions of traditional Chinese medicine (TCM), reducing their repetitive investment to meet the Chinese medicine import and export trade requirement in future. Moreover, it provides the cornerstone and support for TCM standardization, and makes Chinese medicines standard gain dominance in field of international TCM standards, occupying the high ground of international market in the traditional medicine field of the world. It may promote the "Internet + TCM service" in our country, and let the Chinese medicine industry go out of the country and into the world to contribute to human health.

Discussion on International Standard of English Translation for TCM Pulse Condition Name Terms / 中国中医药信息杂志

By comparing WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region with International Standard Chinese-English Basic Nomenclature of Chinese Medicine from the aspects of word-formation methods, translation methods and specific noun terminology translation methods, this article analyzed the advantages and disadvantages in the translation of pulse condition name terms (floating pulse, deep pulse, rapid pulse, slow pulse, feeble pulse, replete pulse kinds of pluse condition, and intermittent pulse, large pulse, soft pulse) in the two International Standards, with a purpose to provide references for the work of the international standardization of TCM terms.

Performance Evaluation of the Real-Q Cytomegalovirus (CMV) Quantification Kit Using Two Real-Time PCR Systems for Quantifying CMV DNA in Whole Blood

Standardized cytomegalovirus (CMV) DNA quantification is important for managing CMV disease. We evaluated the performance of the Real-Q CMV Quantification Kit (Real-Q assay; BioSewoom, Korea) using whole blood (WB), with nucleic acid extraction using MagNA Pure 96 (Roche Diagnostics, Germany). Real-time PCR was performed on two platforms: the 7500 Fast real-time PCR (7500 Fast; Applied Biosystems, USA) and CFX96 real-time PCR detection (CFX96; Bio-Rad, USA) systems. The WHO international standard, diluted with CMV-negative WB, was used to validate the analytical performance. We used 90 WB clinical samples for comparison with the artus CMV RG PCR kit (artus assay; Qiagen, Germany). Limits of detections (LODs) in 7500 Fast and CFX96 were 367 and 479 IU/mL, respectively. The assay was linear from the LOD to 10(6) IU/mL (R2 ≥0.9886). The conversion factors from copies to IU in 7500 Fast and CFX96 were 0.95 and 1.06, respectively. Compared with the artus assay, for values 1,000 copies/mL, 73.3% and 80.6% of samples in 7500 Fast and CFX96, respectively, had <0.5 log10 copies/mL. The Real-Q assay is useful for quantifying CMV in WB with the two real-time PCR platforms.

Standardization development in ISO/TC 249 related to acupuncture and moxibustion / 全日本鍼灸学会雑誌

It has been five years since TC 249 was established as a new Technical Committee (TC) at the International Organization for Standardization (ISO), specializing in the field of Chinese traditional medicine. In the second Plenary Meeting held in Den Haag (2011), five working groups (WGs) were established within the TC, two of which specialize in standard development of acupuncture needles (WG3) and other medical devices used in traditional medicine (WG4). Japanese delegates have participated in the discussion within these WGs, paying close attention so as to keep the proposals under discussion consistent with existing Japanese standards and certification standards regulated by the Ministry of Health, Labour and Welfare. However, since most of the participants in TC 249 are clinicians or researchers engaged in medical practices, and not experts on domestic/international standards, discussions on harmonization of the submitted projects often become complicated. In this manuscript, four experts (two from academia and two from companies that manufacture acupuncture needles and moxibustion devices) who attended the fourth plenary meeting held in Durban, South Africa, in May 2013, report on the stage of progress of standardization development in WG3and WG4.

Evaluation of the Department of Neurosurgery of the Seoul National University Hospital

The Department of Neurosurgery (DNS) of the Seoul National University Hospital (SNUH), belongs to the largest and oldest such institutions in Korea. Because of its growing reputation it is hardly surprising that the DNS draws visitor and scholars for clinical education and academic exchange from far beyond Korea. I myself visited the SNUH in February and March 2013. During this time I composed this evaluation in which I compare the DNS to my home Department at the Johannes Gutenberg-University in Mainz/Germany, as well as the situation of Neurosurgery in Korea and Germany in general. In the first part this evaluation summarizes data concerning equipment, staff and organizational structure, as well as educational and scientific issues of the DNS. In the second part some issues of interest are discussed in special regard to the corresponding practices in Germany.