Safety and effective basic requirements for medical equipment and interpretation
Date：2021-06-25 Views：
The terms required to apply the method that proves that conformity adoption is a document that provides objective evidence in conformity. A general principle The design and production of the A1 medical device should ensure that it is used by expected use of the expected use of the expected use of the expected technological knowledge, experience, educational background, training experience, experience, education background, training experience, medical and hardware conditions. Will not harm the safety and health of medical environment, patient safety, users and others; potential risks in use with patient benefits, and have high levels of health and safety methods. YY / T0316 YY / T 0287 ISO 14969 Eight, risk analysis materials "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination A2 medical device design and production should follow safety principles and take care of existing technical capabilities, the following principles should be adopted to ensure that the remaining risks of each hazard are acceptable: (1) Identify known or expected hazards and assess the risk of expected use and expected improper use. (2) Elimination of risks as much as possible in design and production. (3) Reduce the remaining risks as much as possible as much as possible. (4) Inform the remaining risks. YY / T0316 YY / T 0287 Eight, risk analysis information "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination A3 medical equipment should meet its expected performance under the conditions of use, meet the scope of application. YY / T0316 YY / T 0287 ISO 14969 Eight, risk analysis information "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination A4 In the life cycle, in normal use and maintenance, the degree of degradation of the characteristics and performance of the medical device does not affect its safety. YY / T0316 YY / T 0287 ISO 14969 Eight, risk analysis information "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination The design, production and packaging of the A5 medical device should ensure the transportation, storage conditions (such as temperature and humidity changes) specified by its specification, and no adverse effects on product characteristics and performance. YY / T0316 YY / T 0287 ISO 14969 8, risk analysis information "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination A6 All risks and non-expected influence should be minimized and acceptable to ensure that it benefits from risk in normal use. YY / T0316 Eight, risk analysis materials B Medical Device Safety Performance Basic Principles B1 chemical, physical and biological properties B1.1 Materials should be able to ensure that medical equipment meets the requirements of the section A, special attention: (1) The choice of material should be particularly considered to toxic, flammable (if applicable). (2) Consider material and biological tissue, cells, Compatibility of body fluids. (3) The choice of material should consider attributes such as hardness, abrasion resistance, and fatigue strength (if applicable). Yes Compliance YY / T0316 YY / T 0287 ISO 14969 GB / T16886.7 Risk Analysis Information "Medical Equipment Production Quality Management Specification" Aseptic Medical Device Inspection Self-examination Medical instrument registration inspection report (ethylene oxide residue) B1.2 Medical equipment design, production and packaging should reduce pollutants and residues to engage in the risk of transportation, storage, personnel and patients, especially paying attention to the time and frequency of the tissue contact with the human body. Comply with GB / T16886.7 YY / T 0681.1 Medical instrument registration inspection report (ethylene oxide residue) Medical equipment packaging confirmation report B1.3 Medical instruments are designed and produced, and it is possible to ensure that the product is still safe to use when contacting other materials, substances, and gases in normal use. If the medical device is used for administration, the design and production of the product requires the relevant provisions of drug management, and the performance does not change its product performance. No medical device design and production, the product does not come into contact with other materials, substances and gases in normal use. B1.4 Medical equipment design and production should minimize the risk of filter or leaks, pay special attention to carcinogenic, teratogenic and reproductive toxicity. No filter or leakage property when the design and production of medical devices B1.5 Design and Production of Medical Devices should consider the characteristics of the product and its use environment under expected use, and minimize the risk of substances from the product. No medical device does not require the environment B2 infection and microbial contamination B2.1 The design and production of medical devices should reduce the risk of patients, users and others infection. Design should: (1) Easy to operate. (2) minimize microbial leakage from the product and / or use medium microbial exposure. (3) Prevention of people from microbial contamination of medical devices and samples. YY / T0316 Eight, risk analysis materials B2.2 Surrounded by microbial requirements should ensure that microbial requirements are met before use. YY / T0316 GB / T18279 GB / T18280 Eight, risk analysis information 5.4.1 Irradiation sterilization confirmation report 5.4.2 Ethylene oxide sterilization confirmation report B2.3 Sterile medical devices should be ensured before use. GB / T18279 GB / T18280 Eight, risk analysis information 5.4.1 radiation
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