1. What are the differences between GB9706.1-2020 and GB9706.1-2007?
The Medical Device Standard Management Center of the National Medical Products Administration organized the National Technical Committee for Standardization of Medical Appliances to carry out the research. The "GB9706.1-2007, GB 9706.15-2008, YY/T 0708-2009 and GB 9706.1-2020" and "GB 9706.1-2020 and GB9706.1-2007" have been formed in the order of the old and new standard clauses.
2. If the manufacturer has carried out risk management according to YY/T0316 "Application of Medical Device Risk Management to Medical Devices", can its risk management documents directly meet the requirements of GB9706.1-2020 on risk management?
YY/T0316 provides a process for identifying hazards (sources) associated with medical devices, estimating and evaluating associated risks, controlling those risks, and monitoring the effectiveness of controls. YY/T0316 provides a framework for manufacturers to manage risks associated with medical devices without specifying a specific hazard (source) or hazard situation or an acceptable level of risk.
GB9706.1-2020 not only stipulates that the risk management process shall meet the relevant requirements of YY/T0316, but also requires the risk management process to determine whether the standard requirements take into account all hazards (sources) of ME equipment or system; How particular tests are applied to particular ME devices or systems; Establish an acceptable level of risk and assess residual risk when there are no specific acceptable criteria for a particular hazard (source) or hazardous situation; Evaluate the acceptability of alternative risk control strategies.
Therefore, if the manufacturer carries out risk management in accordance with YY/T0316 "Application of Medical Device Risk Management to Medical Devices", it does not mean that its risk management documents directly meet the requirements of GB9706.1-2020 on risk management, and further inspection should be carried out according to the requirements of GB9706.1-2020.
3. How does the manufacturer determine the basic performance of the equipment?
First, the manufacturer needs to confirm whether the equipment has applicable special safety standards, if there are applicable special safety standards, the manufacturer needs to check whether the special safety standards for the basic performance specified in the basic safety standards, if the special safety standards for this type of equipment specified in the basic performance, the manufacturer determines that the basic performance should include at least the basic performance specified in the special safety standards. In addition to the basic performance specified in the specific safety standard, the manufacturer can identify more basic performance through the risk management process.
If there is no applicable special safety standard for the equipment or the basic performance is not specified in the special safety standard, the manufacturer determines through the risk management process which performance is the basic performance or determines that the equipment does not have the basic performance. (Baseline performance: The performance of a clinical function not related to baseline safety, the loss or reduction of which would result in unacceptable risk in excess of manufacturer-specified limits.)
4. Under what circumstances does it not need to provide key components and materials?
If the failure of any component in the device does not lead to a dangerous situation, it is considered that there is no key component in the device, and therefore, it is not necessary to provide key component information.
5. When is it not necessary to provide documents related to programmable Medical Electrical system (PEMS)?
The requirements of Chapter 14 of GB9706.1-2020 do not apply if the programmable Medical electrical system (PEMS) is not expected to be connected to the IT-network and the programmable electronic subsystem (PESS) does not provide the functions or risk management necessary for basic safety or basic performance, indicating that the failure of any PESS would not result in unacceptable risk. In this case, the manufacturer does not need to provide documentation for programmable medical electrical systems (PEMS) during testing.
6. If the certification certificate and specification of the switching power supply have been provided, do you need to provide the test report of the switching power supply?
Sometimes the certificate and specification of switching power supply cannot provide the information needed in the testing process, while the testing report of switching power supply can supplement the information not reflected in the certificate and specification. If the manufacturer can provide the testing report of switching power supply, the communication time between the equipment manufacturer and the switching power supplier in the testing process can be effectively reduced. Speed up the process of detection work.
7, if the lithium battery meets the requirements of GB31241, is it also required to meet the requirements of GB/T 28164?
The lithium battery must meet the requirements of GB/T 28164, which is the minimum requirement of GB9706.1-2020. Therefore, the lithium battery must meet the requirements of GB9706.1-2020 no matter whether the lithium battery meets the requirements of GB31241 or other lithium battery standards (such as the UL standard).
In addition, lithium battery pack is often used in the equipment now, lithium battery pack is usually composed of a number of single cell and protection circuit board, for this case, the whole lithium battery pack should meet the requirements of GB/T28164, only the single cell in line with GB/T28164 is not enough, this point should be noted.
