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Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Work Procedures for the Inspection of the Quality Management System for the Registration of Class III Medical Devices in China

Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Work Procedures for the Inspection of the Quality Management System for the Registration of Class III Medical Devices in China

2022-02-14

In order to do a good job in the verification of the quality management system of medical device registration, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Medical Device Registration and Filing", "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" and other relevant laws and regulations, the National Bureau organized the revision of " The Work Procedures for the Verification of the Quality Management System for the Registration of the Domestic Class III Medical Devices" is hereby issued and shall come into force on the date of promulgation. The original State Food and Drug Administration's "Notice on Printing and Distributing the Work Procedures for the Inspection of the Quality Management System for the Registration of Class III Medical Devices in China (Interim)" (Food and Drug Administration [2015] No. 63) shall be repealed at the same time.

Water quality testing

Water quality testing

2022-01-18

Water is the source of life and it is closely related to our health. In all walks of life, the role of water should not be underestimated. Because of this, whether it is drinking water, secondary water supply, medical wastewater, etc., there are strict specifications and requirements for water quality. Such as "GB-3838 Environmental Quality Standard for Surface Water", "GB/T5750 Standard Test Method for Drinking Water", "GB/T14848 Groundwater Quality Standard", "GB17051 Hygienic Specification for Secondary Water Supply Facilities", "GB/T17218 Drinking Water Chemistry Hygienic Safety Evaluation of Treatment Agents, etc.

Water quality testing and testing indicators

Water quality testing and testing indicators

2022-01-18

1. Chromaticity: When the chromaticity of drinking water is greater than 15 degrees, most people can perceive it, and when it is greater than 30 degrees, people feel disgusted. The standard stipulates that the chromaticity of drinking water should not exceed 15 degrees. 2. Turbidity: It is an expression of the optical properties of water samples. It is used to express the degree of clarity and turbidity of water. It is one of the most important indicators to measure the goodness of water quality. An important basis for the state of technology. The reduction of turbidity means that the content of organic matter, bacteria, viruses and other microorganisms in the water body is reduced, which can not only improve the disinfection and sterilization effect, but also help reduce the generation of halogenated organic matter.

Current status and development of medical device testing

Current status and development of medical device testing

2022-01-18

The development of international medical equipment testing In the 1970s, the measurement work of international laboratory medicine had already started. In 1976, the United States issued the "Medical Device Amendment", and the Food and Drug Administration (FDA) was responsible for the safety management of medical devices. In 1990, the United States promulgated the "Medical Device Safety Act" to supervise the safety of medical devices according to law. On this basis, hospitals have successively incorporated the quality of medical equipment use into medical quality management, and established relevant systems, qualifications and quality control standards. In 2003, the International Bureau of Weights and Measures established the "Medical Metrology Technical Advisory Committee". According to the objectives and principles of the WTO/TBT agreement, the government is required to pay attention to medical measurement and the safety of medical equipment.

Quality Control Measures of Medium in Microbiological Testing

Quality Control Measures of Medium in Microbiological Testing

2022-01-18

Culture medium is a substance in liquid, semi-solid or solid form, containing natural or synthetic components, intended to ensure the reproduction of microorganisms or to maintain their viability. The preparation and use of the culture medium is an important link in the testing work of the microbiological laboratory. The quality of the culture medium itself, whether it is properly stored, and whether it is prepared and used will directly affect the accuracy of the test results. This article discusses the quality control measures that microbiology laboratories should take in the purchase, storage, preparation, and use of culture media, and talks about some opinions and opinions. Hope to help colleagues in microbiological testing work better.

Clean room testing methods and procedures

Clean room testing methods and procedures

2022-01-18

Clean area is a limited space where the concentration of suspended particles in the air is controlled. The construction and use should reduce the introduction, generation and retention of particles in the space, and other relevant parameters in the space, such as temperature, humidity, and pressure, should be controlled. Air cleanliness refers to the degree of dust particles in the air in a clean environment. If the dust concentration is high, the cleanliness is low. If the dust concentration is low, the cleanliness is high.

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