医疗器械安全有效基本要求清单译文.doc

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, sufferers safety as well as safety and health of users and others; compared with the sufferers 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);B2.6The package of the non-sterile medical device shall keep the integrity and cleanliness of the product. As far as the product sterilized before using, the package shall reduce the risk caused by the microorganism pollution as far as possible and be suitable for the corresponding sterilization method.B2.7If the medical device can appear on the market in sterile and non-sterile states, and the package or label of the products shall be distinguished.B3B3.1The safety, quality and performance of the drug and medical device combined product shall be proved.B4B4.1As far as the medical device including the animal origin free tissues, cell and other matters, the animal origin free tissues, cell and other matters shall conform to the relevant laws and regulations and the applicable range. The source data of animal shall be properly kept for reference. The processing, storing, detection and treatment of the tissues, cell and other matters shall provide the best safety protection to sufferers, users and other persons (if applicable). The virus and other infection agent shall be processed by the proved removing or inactivation method.B4.2The medical device including the human tissues, cell and other matters shall select the suitable source and donator to reduce the infection risk. The processing, storing, detection and treatment of the tissues, cell and other matters shall provide the best safety protection to sufferers, users and other persons (if applicable). The virus and other infection agent shall be processed by the proved removing or inactivation method.B4.3As far as the medical device including the microorganism cell and other matters, the processing, storing, detection and treatment of cell and other matters shall provide the best safety protection to sufferers, users and other persons (if applicable). The virus and other infection agent shall be processed by the proved removing or inactivation method.B5Environmental characteristicsB5.1If the medical device is expected to be combined with other medical device or equipment, it must ensure the safety of the whole system after the combination; and the performance of each device or equipment is not weakened. The limiting of any combination use shall be indicated on the label and (or) specification. The connection system, such as liquid, gas transmission or mechanical coupling and the like shall reduce the safety risk to the users cased by the error connection on the design and structure as far as possible.B5.2 B5.2.1The design and manufacturing of the medical device shall reduce and remove the following risks as far as possible:Risk to sufferers, users or other persons due to physical or man-machine effect reason.B5.2.2Risk of error operation caused by man-machine effect, human factor and using environment.B5.2.3Risk related to reasonably expected external factors or environment conditions, such as radiation, pressure, humidity, temperature, pressure and acceleration change caused by magnetic field, external electromagnetic effect, electrostatic discharge, diagnosis and treatment.B5.2.4Risk caused by contacting with materials, liquid and gas during normal use.B5.2.5Risk caused by the compatibility of software and operation environment.B5.2.6Risk caused accidently entered substances.B5.2.7Risk caused by the mutual interference of the product combined with other medical device during clinic use.B5.2.8Risk caused by the aging material, reduced measurement and control precision of the medical device capable of being maintained or corrected (such as implanting product).B5.3The design and manufacturing of the medical device shall reduce the combustion and explosion risk under the normal use and single fault state as far as possible, specifically the medical device exposed in combustible and burning object or combined with the combustible and burning object during expected use.B5.4The design and manufacturing of the medical device capable of being adjusted, corrected and maintained shall ensure the safe corresponding process.B5.5The design and manufacturing of the medical device shall be good for the safe disposal of the wastes.B6Medical device product with diagnosis or measuring functionB6.1The design and manufacturing of the medical device with diagnosis or measuring function shall consider the accuracy, precision and stability. The accuracy shall regulate the limiting value.B6.2The design of any measuring, monitoring or displaying value shall conform to the principle of man-machine effect.B6.3The expressed variable shall be the standard unit in China and understood by the users.B7Radiation protectionB7.1General requirements: the design, manufacturing and package of the medical device shall reduce the exposure of the sufferers, users and other persons in the radiation without affecting the functions.B7.2Expected radiation: the radiological dose of the medical device carrying out treatment by radiation shall be controlled. The design and manufacturing shall ensure that the repeatability and error of the relevant adjustable parameter are in the allowable range. If the expected radiation of the medical device has harm, it shall have corresponding sound alarm function.B7.3Non-expected radiation: the design and manufacturing the medical device shall reduce the risk of sufferers, users and other persons exposed in non-expected, stray or scattered radiation as far as possible.B7.4Ionizing radiation: the design and manufacturing of the medical device radiating the ionizing radiation shall ensure that the dose, geometric distribution and energy distribution (quality) of the radiation can be controlled.The design and manufacturing of the medical device radiating the ionizing radiation (used for radiologic diagnosis) shall ensure the minimum radiation dose suffered by the sufferers and users when the products realize the imaging quality needed by clinic. The dose, beam type, energy and energy distribution (when applicable) of the radiation beam can be reliably monitored and controlled.B8Medical device comprising software and independent medical device softwareB8.1The design of the medical device comprising software and independent medical device software shall ensure the repeatability, reliability and performance. When taking place the single fault, proper measures shall be taken to reduce and remove the risk as far as possible.B8.2As far as the medical device comprising software and independent medical device software, the design must be confirmed (considering the research cycle), risk management requirement, test and confirming requirements) according to the latest technical level.B9Active medical device and device connected with the active medical deviceB9.1As far as the active medical device, when taking place single fault, proper measures shall be taken to reduce and remove the risk as far as possible.B9.2The sufferer safety is ensured by the medical device supplied with power by the internal power; and the medical device shall have the function of detecting the power supply state.B9.3The sufferer safety is ensured by the medical device supplied with power by the external power; and the medical device shall comprise the alarm system capable of displaying the power fault.B9.4The medical device expected to monitor one or multiple clinic parameters of the sufferer shall be provided with proper alarm system which can alarm when the sufferers health is seriously worsened or in danger.B9.5The design and manufacturing of the medical device shall have the method of reducing the electromagnetic interference.B9.6The design and manufacturing of the medical device shall ensure that the product has enough ability of anti-electromagnetic interference so as to run the product expectedly.B9.7The design and manufacturing of the medical device shall ensure that the sufferers, users and other person are free from the accident electrical shock after being installed and maintained according to the requirements and during the normal use and the single fault.B10Protection of mechanical riskB10.1The design and manufacturing of the medical device shall protect the sufferers and users from the mechanical risk caused by the resistance, unstable parts and moving parts because of movement.B10.2Unless the vibration is the special performance requirements of the medical device, the design and manufacturing of the medical device shall minimize the risk caused by the vibration. If it is possible, the method for limiting the vibration (especially for the vibration source) shall be taken.B10.3Unless the noise is s the special performance requirements of the medical device, the design and manufacturing of the medical device shall minimize the risk caused by the noise. If it is possible, the method for limiting the vibration (especially for the vibration source) shall be taken.B10.4As far as the terminal and connector operated by users and connected with the electricity, gas or providing liquid pressure and gas pressure, the design and structure shall reduce the operation risk as far as possible.B10.5If some parts of the medical device are connected or connected again before the use or during the use, the design and manufacturing shall minimize the risk of the error connection.B10.6The touchable medical device part (including the part and area providing the heat or reaching the given temperature expectedly) shall not reach the temperature capable of causing risk during the normal use.B11Protection of risk generated when providing sufferer energy or substancesB11.1The design and structure of the medical device for providing energy or substances to the sufferer shall be set accurately and keep the output quantity to ensure the safety of the sufferers and users.B11.2The insufficient output quantity can result in risk; and the medical device shall have the functions preventing and/or indicating insufficient output quantity. It shall have proper prevention manner to prevent the energy or substance of which the accident output reaches the danger level.B11.3The function of the controller and the indicator shall be clearly marked on the medical device. The using specification, running state or adjusting parameter of the device are indicated by the display system, the information shall be understood.B12Protection of using risk of non-professional usersB12.1The design and manufacturing of the medical device shall consider the knowledge, skill and using environment mastered by non-professional users; and enough specification shall be provided for convenient understanding and using.B12.2The design and manufacturing of the medical device shall reduce the risk caused by the error operation and understanding of non-professional users as far as possible.B12.3The medical device shall be set to check whether the product is the program of normal operation or not during the using process.B13Label and specificationB13.1In view of the training and knowledge of the user, the label and specification shall provide enough information to the users to identify the enterpr