The objective of inspection, testing and supervision of medical devices is to ensure the effectiveness and safety of medical devices in use. Leachables are substances that are leached from medical devices or materials during their clinical use. Leachables are important factors for the safety risks of medical devices. The analysis, detection, and safety evaluation of leachables are important parts of the safety evaluation of medical devices. The allowable limits for leachable substances which are established on the toxicological research provide a scientific basis for the judgment of qualitative and quantitative analysis results. Obtaining more detailed, rigorous and sufficient toxicological research data is of great significance to set highly enforceable product technical indicators. For the establishment of allowable limits for leachable substances, its role in the safety evaluation of medical devices is summarized, and the relevant standards and their implementation status in the testing of medical devices are introduced.
Equipment and Supplies/standards* ; Equipment Safety

Antimicrobial resistance (AMR) is increasingly becoming a threat to global public health, not least in low- and middle-income countries (LMICs) where it is contributing to longer treatment for illnesses, use of higher generation drugs, more expenditure on antimicrobials, and increased deaths attributed to what should be treatable diseases. Some of the known causes of AMR include misuse and overuse of antimicrobials in both humans and animals, unnecessary use of antimicrobials in animals as growth promoters, and lack of awareness among the public on how to protect antimicrobials. As a result, resistant organisms are circulating in the wider environment, and there is a need to consider the One Health approach to minimise the continuing development of AMR. Environmental Health, specifically water, sanitation and hygiene (WASH), waste management, and food hygiene and safety, are key components of One Health needed to prevent the spread of antimicrobial-resistant microorganisms particularly in LMICs and reduce the AMR threat to global public health. The key Environmental Health practices in the prevention of AMR include: (1) adequate WASH through access and consumption of safe water; suitable containment, treatment and disposal of human excreta and other wastewater including from health facilities; good personal hygiene practices such as washing hands with soap at critical times to prevent the spread of resistant microorganisms, and contraction of illnesses which may require antimicrobial treatment; (2) proper disposal of solid waste, including the disposal of unused and expired antimicrobials to prevent their unnecessary exposure to microorganisms in the environment; and (3) ensuring proper food hygiene and safety practices, such as sale and consumption of animal products in which adequate antimicrobial withdrawal periods have been observed, and growing vegetables on unpolluted soil. Environmental Health is therefore crucial in the prevention of infectious diseases that would require antimicrobials, reducing the spread of resistant organisms, and exposure to antimicrobial residues in LMICs. Working with other professionals in One Health, Environmental Health Practitioners have a key role in reducing the spread of AMR including health education and promotion, surveillance, enforcement of legislation, and research.
Developing Countries ; Disease Transmission, Infectious/prevention & control* ; Drug Resistance, Microbial ; Environmental Health/standards* ; Food Safety ; Health Personnel/standards* ; Humans ; Hygiene/standards* ; Role ; Sanitation/standards* ; Waste Management/standards*

Betacoronavirus ; Coronavirus ; Coronavirus Infections ; epidemiology ; prevention & control ; Disease Transmission, Infectious ; prevention & control ; Guidelines as Topic ; Humans ; Infection Control ; organization & administration ; Pandemics ; prevention & control ; Personal Protective Equipment ; standards ; Pneumonia, Viral ; epidemiology ; prevention & control ; Primary Prevention ; methods ; standards ; Safety ; standards ; Safety Management

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.
Disposable Equipment/standards* ; Equipment Safety ; Injections, Intradermal/instrumentation* ; Syringes

BACKGROUND: With increasing media coverage of food safety incidents, such as that of clenbuterol residues in pork, food safety has become a major public health concern in China. Rapidly developing online markets attract increasing numbers of Chinese consumers to purchase food on the Internet. However, the quality and safety of food sold online are uncertain and are less reported on. OBJECTIVE: This research aimed to systematically study the quality and safety of chilled pork from wet markets, supermarkets, and online markets in China. RESULTS: The chilled pork samples from online markets were fresher than those from wet markets and supermarkets based on the surface redness (a* value). Chilled pork contained high levels of nutritional elements, especially the magnesium and phosphorus levels in samples from online markets. The levels of heavy metal element residues and veterinary drug residues in all chilled pork samples were within the standards limits. In addition, huge differences existed in the quality and freshness of the chilled pork samples from online markets according to principal component analysis (PCA). CONCLUSIONS Most chilled pork sold in Chinese markets was qualified and safe. It is necessary to establish an effective online market supervision system for chilled pork.
Animals ; China ; Cold Temperature ; Drug Residues/analysis* ; Food Preservation/standards* ; Food Quality ; Food Safety ; Metals, Heavy/analysis* ; Principal Component Analysis ; Red Meat/standards* ; Sus scrofa ; Veterinary Drugs/analysis*

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.
Equipment Safety ; Equipment and Supplies ; Industry ; Reference Standards

Cosmetics containing botanic ingredients have been used from thousands of years up to now in China. Because of the consumers' demand for health and beauty,the number of products about " botanic" have been growing rapidly in the cosmetics market,which has played an important role in upgrading the industry and enhancing the international competitiveness nowadays. Therefore,to strengthen the management about used botanic raw materials in cosmetics products and revise the application regulation of new raw materials has become an important work to ensure product quality,promote the healthy and stable development of cosmetic business. The article summarizes the related mandatory regulations and standards about botanic ingredients which used as activity function in major cosmetic business countries or regions. Furthermore,the information of botanic ingredients commonly used in non-special cosmetics notification and special cosmetic registration system were described to expect the better application and development.
China ; Consumer Product Safety ; Cosmetics/standards* ; Government Regulation ; Plant Preparations/standards*

Cupping therapy (Hijama in Arabic) is a popular traditional treatment especially in Asia, the Middle East and Central Europe. Traditionally, cupping therapy has been one of the most used practices in Saudi Arabia. Standardization of the practice of cupping therapy is a very important step to eliminate or reduce any adverse events related to cupping. This article gives a brief illustration and highlights the important points of the first accredited Saudi Arabian standards for the safe use of cupping equipment and its applications.
Equipment Safety ; standards ; Government Regulation ; Humans ; Medicine, Traditional ; instrumentation ; methods ; standards ; Safety ; standards ; Saudi Arabia

Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.
Equipment Safety ; Equipment and Supplies ; standards ; Industry ; Reference Standards

Concern about the biological hazards involved in microbiological research, especially research involving laboratory animals, has increased in recent years. Working in an animal biosafety level 2 facility (ABSL-2), commonly used for research on infectious diseases, poses various biological hazards. Here, the regulations and standards related to laboratory biosafety in China are introduced, the potential biological hazards present in ABSL-2 facilities are analyzed, and a series of strategies to control the hazards are presented.
Animal Diseases ; epidemiology ; prevention & control ; Animals ; Biomedical Research ; legislation & jurisprudence ; China ; epidemiology ; Containment of Biohazards ; methods ; standards ; Government Regulation ; Laboratories ; legislation & jurisprudence ; standards ; Safety Management ; legislation & jurisprudence ; standards