List of basic requirements on safe and effective medical deviceRegulation numberRequirementsApplicableAdopted method for proving conformanceFile providing objective evidence to conformanceAGeneral principlesA1The design and manufacturing of medical device shall ensure to be used according to the expected using manner by the expected users (if applicable) with corresponding technology knowledge, experience, education, training, medical treatment and hardware condition under the expected conditions and purposes; it will not damage the medical environment, sufferer’s safety as well as safety and health of users and others; compared with the sufferer’s benefits, the potential risk can be accepted; and the high-level health and safety protection method is available.1.A2The design and manufacturing of medical device shall abide by the safety principles and consider the existing technology ability; the following principles shall be taken to ensure that the residual risk of each harm can be accepted: (1) Identify the known or expected danger and evaluate the risk under expected use and expected improper use; (2) Eliminate risk as far as possible in the design and manufacturing; (3) Reduce the residual risk as far as possible by complete protection measures, such as alarm, etc; (4) Inform the residual risk.A3Under the regulated using condition, the medical device shall reach the expected performance and meet the requirement of applicable range.A4Under the condition of normal use and maintenance, the degeneration degree of the features and performances of the medical device cannot affect the safety in the life cycle. A5The design, manufacturing and packing of the medical device can ensure that the transportation and storage conditions (such as temperature and humidity change) regulated in the specification will not affect the product features and performances. A6All risks and non-expected influences shall be minimized and accepted to ensure that the benefit is greater than the risk during the normal use.BBasic principles of safety performance of medical apparatus and instrumentB1Chemical. Physical and biological propertiesB1.1The materials shall ensure that the medical device conform to the requirements suggested in section A; pay special attention to: (1) The material selection shall consider the toxicity and inflammability (if applicable); (2) Consider the material, biological tissue and cell according to the applicable range;Consistency of liquid (3) The selection of material shall consider the hardness, abrasive resistance, fatigue strength and the like (if applicable).B1.2The design, manufacturing and packing of the medical device must reduce the risk on the transportation, storage and user persons and sufferers caused by the pollutant and residue as far as possible; and pay special attention to the time and frequency when contacting with the exposed parts of human body.B1.3The design and manufacturing of medical apparatus instrument shall ensure that the products can be used safety when contacting with other materials, substances and gas. If the medical apparatus instrument is used for administrating drug, the design and manufacturing of the product must conform to the relevant regulations of the drug management; and the product performance is not changed during the normal use.B1.4The design and manufacturing of the medical apparatus instrument shall reduce the risk caused by the filtering objects or leakage as far as possible; and pay special attention to the carcinogenicity, teratogenicity and reproduction toxicity.B1.5The design and manufacturing of the medical apparatus instrument shall consider the features of the products and the using environment under the expected using condition so as to reduce the risk caused by substances entering from the product accidently.B2Infection and microbial pollutionB2.1The design and manufacturing of the medical apparatus instrument shall reduce the infection risk of sufferers, users and others; and the design shall meet the following conditions: (1) Easy operation; (2) Reduce the microorganism leakage and/or microorganism exposure during usage from the product as far as possible; (3) Prevent the microorganism pollution of human to medical device and samples.B2.2The medical device marked with microorganism requirement shall ensure to conform to the microorganism requirement before using.B2.3Sterile medical device shall ensure to conform to the sterile requirement before using.B2.4The sterile medical device marked with microorganism requirement shall be processed, manufactured or sterilized by the proved method. B2.5The sterile medical device shall be manufactured under the corresponding control state (such as the environment with corresponding purifying grade);B2.。