Characterization and Comparison Analysis of WHO Monographs on Selected Medicinal Plants and ISO Standards of Chinese Materia Medica / 中国结合医学杂志

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.

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.

Current situation of International Organization for Standardization/Technical Committee 249 international standards of traditional Chinese medicine / 中国结合医学杂志

<p><b>OBJECTIVE</b>To review the current situation and progress of traditional Chinese medicine (TCM) international standards, standard projects and proposals in International Organization for Standardization (ISO)/ technical committee (TC) 249.</p><p><b>METHODS</b>ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group (WG), current stage and classifification.</p><p><b>RESULTS</b>In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fifields, 7 groups and sub-groups based on International Classifification Standards.</p><p><b>CONCLUSION</b>A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.</p>

Discussion on Standardization ISO 15189 quality management system as the teaching content for laboratory medicine / 中华医学教育探索杂志

ISO 15189 standard quality management system developed by the International Organi-zation for Standardization (ISO) embodies the international medical laboratory's latest quality management concept, and puts forward the quality improvement method of the standard. In this research, ISO 15189, as an important content in practice teaching for laboratory medicine, was designed according to the elements of this system. Students were requested to participate in every linkage of laboratory quality management by writing system document, taking part in quality activity, and practicing the key and difficult points of tech-nique in quality system in order not only to cultivate their basic idea of ISO 15189 standard, but also to make them familiar with the basic patterns of laboratory accreditation system and process, which could make them become the backbone of the laboratory quality management quickly in their vocational positions in the future.

Comparison and Investigation of the National Standards for Tinted Contact Lenses between Various Countries

PURPOSE: In this study we investigated the safety level of the national standard for tinted soft contact lenses by comparing the standards in various countries. METHODS: To evaluate the current guidelines for tinted soft contact lenses such as form and appearance, diameter, curvature radius, vertex power, cylindrical refractivity and cylindrical axis, luminous/ultraviolet ray (UV) transmittance, moisture content, oxygen permeability coefficient, extractables, elution test, cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity, genotoxicity and biocompatibility safety test using rabbit eyes and sterility test. We compared the standards of International Organization for Standardization (ISO), Food and Drug Administration (FDA) of the United States, Ministry of Health, Labor and Welfare (MHLW) of Japan and Ministry of Food and Drug Safety (MFDS) of Korea. RESULTS: The guidelines for tinted soft contact lenses of ISO, FDA and MFDS are similar to soft contact lenses but MHLW of Japan classifies these lenses and sets specific guidelines. First, the oxygen permeability coefficient measured at 6mm from the center should be maintained over 80%. Also, coloring should not affect the oxygen permeability coefficient significantly. Regarding the physical (form and appearance, diameter, curvature radius, moisture content) and optical (vertex power, cylindrical refractivity and cylindrical axis, luminous/UV transmittance, oxygen permeability coefficient) characteristics, no differences were found between ISO and MFDS. However, several differences were found in chemical characteristics (extractables, elution test) and biological stability (cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity test, genotoxicity, biocompatibility safety test using rabbit eyes, sterility test). For example, the elution test is required only by MFDS. CONCLUSIONS: The reinvestigation into the effectiveness of the elution test is needed and new evaluation measures including scanning electron microscopy and atomic force microscopy designed for tinted soft contact lenses to evaluate the size of the optical area, the location and roughness of the pigmented layer are required.

Diversity, Utility, Analytical Methods and Use Implications of Aroma-active Compounds from Select Angiosperm Familie.

Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods.

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.

Discussion of GMP Certification in Pharmaceutical Enterprise after 2004 in China / 中国药房

OBJECTIVE:To predict the trend of Good Manufacturing Practice(G MP)certification in China after2004.METHODS:The development and the current situation of GMP certification were summarized,the problems as well as the suggestions were put forward.RESULTS&CONCLUSIONS:GMP certification after2004should be integrated with Inter?national Organization for Standardization(ISO),the domain correlated drug and"Good Agricultural Practices"(GAP),it should be design rational project of GMP certification on the basis of specificity of enterprises in China.