CN113128889A - Method for evaluating electromagnetic compatibility model of medical air pressurization oxygen chamber - Google Patents
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Abstract
The invention discloses a method for evaluating the electromagnetic compatibility model of a medical air pressurization oxygen chamber, which belongs to the technical field of medical instrument inspection and comprises the following steps: s1: typical screening is carried out, and representative models are screened; s2: carrying out representative model detection and outputting a representative model detection result; s3: comparing the results representing whether the model checking result meets the EMC standard requirement, if so, entering S4, and if not, returning to S2; s4: performing risk evaluation on other models except the representative model, and outputting risk items; s5: synthesizing the risk items to obtain a result of whether the risk is acceptable, if so, entering S6, and if not, returning to S4; s6: and outputting an evaluation report. The technical scheme of the invention can effectively solve the problems in inspection and registration, is beneficial to order production of production enterprises, and reduces the registration cost of manufacturers.
Description
Technical Field
The invention relates to the technical field of medical instrument inspection, in particular to a method for evaluating the electromagnetic compatibility model of a medical air pressurization oxygen chamber.
Background
A medical air pressurization oxygen cabin (hereinafter referred to as an oxygen cabin) is a special manned pressure container and is used for various treatment equipment for anoxia. According to the requirements of GB/T12130 medical air pressurization oxygen chamber, the medical air pressurization oxygen chamber is generally composed of a chamber body, an air supply and exhaust system, an oxygen supply system, an air conditioning system and an electrical system. According to the registration regulation of medical appliances, the medical hyperbaric oxygen chamber is generally divided into models according to the size, arrangement form and the number of accommodated treatment persons of the chamber body; the size of the chamber body ranges from 0.8m to 4.2m, the number of people ranges from 1 to 50, and the factors can be combined with each other, so that the specification and the model number of the medical hyperbaric oxygen chamber can reach more than 50 or even hundreds. As most of the medical hyperbaric oxygen chambers are large permanent installation equipment, the structure composition is complex, the manufacturing cost is high, and the production period is long, the order type production is usually adopted.
As can be seen from the above description, some models of medical air pressurized oxygen chambers are very large in volume and high in manufacturing cost, and the actual regulations cannot be registered for the medical air pressurized oxygen chambers which do not pass quality inspection, on one hand, such medical device products need to provide all models of samples to perform inspection of each model; on the other hand, order-type production of such products cannot meet these requirements. Therefore, the inspection and approval of such medical device products becomes a great problem in the related aspect.
Disclosure of Invention
In order to solve the defects in the prior art, the invention aims to provide the method for evaluating the electromagnetic compatibility model of the medical air pressurization oxygen chamber, the method is suitable for the inspection and approval before the registration of a large batch of models of the medical air pressurization oxygen chamber, the difficult problems in the inspection and registration can be effectively solved, the ordered production of a production enterprise is facilitated, and the registration cost of a manufacturer is reduced.
The technical scheme adopted by the invention for solving the technical problems is as follows:
the utility model provides a method for evaluating the electromagnetic compatibility model of a medical air pressurization oxygen chamber, which comprises the following steps:
s1: typical screening is carried out, and representative models are screened;
s2: carrying out representative model inspection on the screened representative models, and outputting representative model inspection results;
s3: comparing the representative model checking result with the EMC standard to obtain a result indicating whether the model checking result meets the EMC standard requirement, if so, entering S4, and if not, returning to S2;
s4: performing risk evaluation on other models except the representative model, and outputting risk items;
s5: synthesizing the risk items to obtain a result of whether the risk is acceptable, if so, entering S6, and if not, returning to S4;
s6: and outputting an evaluation report.
Further, in S1, a typical screening is performed, including:
s1.1: classifying the medical air pressurization oxygen chamber into a plurality of sub-categories;
s1.2: at least one typical model is selected from each subcategory as a representative model according to typical characteristics;
s1.3: and performing supplementary improvement on the representative model.
Further, in S1.1, the medical air pressurized oxygen chambers are classified according to one or more of the following parameters: the medical air pressurization oxygen chamber has the functions, the composition, the wiring, the chamber body layout, the auxiliary function, the control mode, the chamber body size, the composition and the distribution of a control console and core electrical components.
Further, in S2, the representative model check includes:
running a measuring program by using an electromagnetic disturbance measuring instrument, and measuring an emission index of the medical air pressurization oxygen cabin;
performing transient immunity test on the medical air pressurization oxygen cabin by using an electrostatic discharge test device, a pulse group test device, a surge test device, a power frequency test device and a voltage sag or interruption test device;
and running a conduction immunity and radiation immunity test program by using test equipment to test the conduction immunity and radiation immunity of the medical air pressurization oxygen chamber.
Further, in S3, comparing the representative model test result with the EMC standard to obtain a result indicating whether the model test result meets the EMC standard requirement, and the determining step is:
s3.1: judging whether the emission index meets the requirement or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.2: judging whether all the immunity tests meet the requirements or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.3: if the emission index and the immunity test of each representative model meet the requirements, the representative model meets the requirements of relevant standards of electromagnetic compatibility;
s3.4: all the emission indexes and the immunity tests of all the representative models meet the requirements, and the registration unit of the medical air pressurization oxygen chamber is regarded as meeting the requirements;
s3.5: and if the requirements are not met, performing relevant modification on the sample, repeating the step S2 and the steps S3.1-S3.4 until the requirements are met, and simultaneously recording representative models and projects which do not meet the requirements.
Further, in S4, the outputting the risk item includes:
s4.1: identifying a danger source: according to the configuration of the medical air pressurization oxygen chamber, the danger of each functional module related to electromagnetic compatibility is obtained, and therefore a danger source is identified;
s4.2: risk estimation: according to the EMC danger condition of the medical air pressurization oxygen chamber, estimating the risk severity and the risk probability grade qualitatively, and integrating the risk severity and the risk probability grade to obtain the risk grade;
s4.3: judging whether the risk needs to be reduced: according to the risk level, the following steps are carried out:
firstly, establishing an acceptable criterion of risk;
second, all the foreseeable event sequences are traversed and, based on the risk level and the acceptability criteria, unacceptable risks are screened, which are set as risks that need to be reduced.
S4.4: and (3) risk control:
firstly, taking corresponding risk control measures according to a specific event sequence;
secondly, verifying the effectiveness of the risk control measures;
finally, whether the risk control measures introduce new risks or influence is judged to be acceptable risks is checked, and if any one of the situations exists, the S4.2 is returned for the risk control measures, the introduced new risks or the influenced acceptable risks;
s4.5: determining whether the remaining risk is acceptable:
firstly, after a risk control measure is taken, the residual risk is evaluated again, and the residual risk is determined to accord with an acceptable criterion;
secondly, if the residual risk is not acceptable, supplementing the representative model and completing the inspection;
s4.6: the remaining risk is output as a risk item.
Further, in S5, synthesizing the risk items to obtain a result indicating whether the risk is acceptable includes:
s5.1: checking for remaining risk: the remaining risk that may remain is checked from the following five aspects: evaluating a drawing, evaluating a construction process, evaluating a key part list, and judging whether a new risk and an electrical relevance risk are caused by a rectification measure;
s5.2: determining whether it is acceptable: if the comprehensive residual risk meets the acceptable criterion, the comprehensive residual risk is regarded as acceptable risk, and an evaluation conclusion is output; otherwise, the models with the remaining risks should be subjected to risk evaluation of other models again until the comprehensive remaining risks of the remaining models are acceptable risks.
Further, the evaluation report includes a test report representing the model number and an evaluation instruction.
Further, the method for supplementing the representative model includes:
performing addition according to the inspection data and analysis; or, the modification measure application situation adopted by the representative model which is detected to be qualified is added.
Further, the test data is a typical model of test data or a random model of pretest data.
Compared with the prior art, the invention has the beneficial effects that:
the electromagnetic compatibility model evaluation method for the medical air pressurization oxygen cabin provided by the invention starts from an electromagnetic compatibility test project, analyzes the difference of the medical air pressurization oxygen cabin, and starts typical screening so as to carry out a model evaluation process. The method is used for guiding large-batch model pre-registration inspection and approval of the medical air pressurization oxygen chamber, can effectively solve the problems in inspection and registration, is beneficial to order production of manufacturers, and reduces the registration cost of manufacturers.
Drawings
Other features, objects and advantages of the present application will become more apparent upon reading of the following detailed description of non-limiting embodiments thereof, made with reference to the accompanying drawings in which:
FIG. 1 is an overall flow diagram of an embodiment of the present invention;
fig. 2 is a flowchart of the "risk assessment for other models" section in the embodiment of the present invention.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention.
The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention.
All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. It should be noted that, for convenience of description, only the portions related to the present invention are shown in the drawings.
In the present invention, EMC represents the meaning of electromagnetic compatibility, and as shown in fig. 1, an embodiment of the present invention provides a method for evaluating electromagnetic compatibility of a medical air pressurized oxygen chamber, including:
s1: typical screening is performed to screen representative models.
At S1, a typical screening is performed, including:
s1.1: classifying the medical air pressurization oxygen chamber into a plurality of sub-categories;
s1.2: at least one typical model is selected from each subcategory as a representative model according to typical characteristics;
s1.3: and performing supplementary improvement on the representative model.
Further, in S1.1, the medical air pressurized oxygen chambers are classified according to one or more of the following parameters: the medical air pressurization oxygen chamber has the functions, the composition, the wiring, the chamber body layout, the auxiliary function, the control mode, the chamber body size, the composition and the distribution of a control console and core electrical components.
In S1, classification and selection are carried out according to the functions, composition, wiring, cabin layout, auxiliary functions, control mode, cabin size, composition and distribution of a console, main electrical components and the like of the medical air pressurization oxygen cabin, and the specific operation steps are as follows:
firstly, according to the functional composition of a medical air pressurization oxygen cabin, the medical air pressurization oxygen cabin is divided into a single cabin and a multi-person cabin; the multi-person cabin can be further subdivided into two categories, a single cabin and a cabin group. And selecting the typical model as a representative model according to the typical characteristics in each category, wherein at least one model is selected from each category.
And secondly, dividing each category into a plurality of subcategories according to the size of the cabin body of the medical air pressurization oxygen cabin, the wiring, the composition and the distribution of a control console and the like. At least one typical model is selected from each sub-category as a representative model according to typical characteristics. When the number is large, more types can be selected.
Then according to the characteristics of auxiliary function, control mode and main components of the medical air pressurized oxygen chamber, the typical model is supplemented and perfected as a representative model.
S2: and performing representative model test on the screened representative models, and outputting test results of the representative models.
In S2, the representative model checking includes:
and running a measuring program by using an electromagnetic disturbance measuring instrument to measure the emission index of the medical air pressurization oxygen cabin. Specifically, the emission indexes of the medical air pressurizing oxygen chamber are measured by using electromagnetic disturbance measuring instruments such as a measuring receiver, a receiving antenna, a loop antenna, an artificial power supply network and the like and running measuring programs such as conduction emission, radiation emission and the like.
The transient immunity test is carried out on the medical air pressurization oxygen cabin by using an electrostatic discharge test device, a pulse group test device, a surge test device, a power frequency test device and a voltage sag or interruption test device.
And running a conduction immunity and radiation immunity test program by using test equipment to test the conduction immunity and radiation immunity of the medical air pressurization oxygen chamber. Specifically, a signal source, a power amplifier, a transmitting antenna, a coupling and decoupling network, a current injection clamp and other testing equipment are used for running a conduction immunity and radiation immunity testing program and testing the conduction immunity and the radiation immunity.
S3: and comparing the representative model test result with the EMC standard to obtain a result indicating whether the model test result meets the requirements of the EMC standard, if so, entering S4, and if not, returning to S2.
In S3, comparing the representative model test result with the EMC standard to obtain a result indicating whether the representative model test result meets the EMC standard requirement, the determining step is:
s3.1: judging whether the emission index meets the requirement or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.2: judging whether all the immunity tests meet the requirements or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.3: if the emission index and the immunity test of each representative model meet the requirements, the representative model meets the requirements of relevant standards of electromagnetic compatibility;
s3.4: all the emission indexes and the immunity tests of all the representative models meet the requirements, and the registration unit of the medical air pressurization oxygen chamber is regarded as meeting the requirements;
s3.5: and if the requirements are not met, performing relevant modification on the sample, repeating the step S2 and the steps S3.1-S3.4 until the requirements are met, and simultaneously recording representative models and projects which do not meet the requirements.
S4: and performing risk evaluation on other models except the representative model, and outputting risk items.
As shown in fig. 2, S4 specifically includes:
s4.1: identifying a danger source: according to the configuration of the medical air pressurization oxygen chamber, the danger related to electromagnetic compatibility of each functional module is obtained, and therefore the danger source is identified.
S4.2: risk estimation: according to the EMC danger condition of the medical air pressurization oxygen chamber, estimating the risk severity and the risk probability grade qualitatively, and integrating the risk severity and the risk probability grade to obtain the risk grade; the method comprises the following steps:
first, the risk severity is qualitatively estimated based on the EMC risk profile of the medical air pressurized oxygen chamber (including the risk category, the foreseeable sequence of events, and the possible occurrence of the risk profile);
secondly, qualitatively estimating the risk probability level according to the EMC risk condition (including risk category, foreseeable event sequence and possible occurrence risk condition) of the medical air pressurization oxygen chamber;
and finally, integrating the severity and probability level of the risk and comprehensively estimating the risk level.
S4.3: judging whether the risk needs to be reduced: according to the risk level, the following steps are carried out:
first, acceptable criteria for risk are established. For model evaluation, the objective is to control the systematic risk of electromagnetic compatibility before all models come to market within the registry unit, and therefore, both acceptable and unacceptable levels are used.
Second, all the foreseeable event sequences are traversed and, based on the risk level and the acceptability criteria, unacceptable risks are screened, which are set as risks that need to be reduced.
S4.4: and (3) risk control:
first, corresponding risk control measures are taken according to a specific event sequence. Common risk control measures are: the intrinsic safety is obtained in the medical air pressurization oxygen chamber by a design method, and corresponding protective measures and use safety information are taken in the manufacturing process of the medical air pressurization oxygen chamber. The safety information is only used for the case that the electrostatic discharge item has special regulation or the related case that can be involved in the electrical safety.
Second, the effectiveness of the risk control measures is verified.
Finally, it is checked whether the risk control measures introduce new risks or influence has been determined as an acceptable risk, and if any of the aforementioned situations exists, the return is made to S4.2 for these risk control measures, the introduced new risks or the influenced acceptable risk.
S4.5: determining whether the remaining risk is acceptable:
first, after taking risk control measures, the remaining risk is re-evaluated to determine that the remaining risk meets acceptable criteria.
Second, if the remaining risk is not acceptable, the representative model is replenished and the test is completed. Specifically, if the remaining risk is not acceptable, further risk control measures should be taken, i.e., supplementing the representative model and completing the test. The method for determining the supplementary representative model number includes: the method is characterized in that the method is added properly on the basis of test data and analysis, and the test data can be test data of a typical model or pretest data of a random model. And secondly, adding the application condition of the rectification measures adopted by the detected qualified representative model.
Finally, the supplementary representative model is checked.
S4.6: the remaining risk is output as a risk item.
S5: and integrating the risk items to obtain a result of whether the risk is acceptable, if so, entering S6, and if not, returning to S4.
In S5, synthesizing the risk items to obtain a result indicating whether the risk is acceptable or not, including:
s5.1: checking for remaining risk: the remaining risk that may remain is checked from the following five aspects: evaluating a drawing, evaluating a construction process, evaluating a key part list, and judging whether a new risk and an electrical relevance risk are caused by a rectification measure;
s5.2: determining whether it is acceptable: if the comprehensive residual risk meets the acceptable criterion, the comprehensive residual risk is regarded as acceptable risk, and an evaluation conclusion is output; otherwise, the models with the remaining risks should be subjected to risk evaluation of other models again until the comprehensive remaining risks of the remaining models are acceptable risks.
S6: and outputting an evaluation report. The evaluation report includes a test report representing the model number and an evaluation description.
In conclusion, the method starts from the test item of electromagnetic compatibility, and analyzes the difference of the medical air pressurization oxygen chamber; typical screening is thus initiated to perform the model evaluation process. The method is used for guiding large-batch model pre-registration inspection and approval of the medical air pressurization oxygen chamber, can effectively solve the problems in inspection and registration, is beneficial to order production of manufacturers, and reduces the registration cost of manufacturers.
The above description is only a preferred embodiment of the application and is illustrative of the principles of the technology employed. It will be appreciated by a person skilled in the art that the scope of the invention as referred to in the present application is not limited to the embodiments with a specific combination of the above-mentioned features, but also covers other embodiments with any combination of the above-mentioned features or their equivalents without departing from the inventive concept. For example, the above features may be replaced with (but not limited to) features having similar functions disclosed in the present application.
Other technical features than those described in the specification are known to those skilled in the art, and are not described herein in detail in order to highlight the innovative features of the present invention.
Claims (10)
1. A method for evaluating the electromagnetic compatibility model of a medical air pressurization oxygen chamber is characterized by comprising the following steps:
s1: typical screening is carried out, and representative models are screened;
s2: carrying out representative model inspection on the screened representative models, and outputting representative model inspection results;
s3: comparing the representative model checking result with the EMC standard to obtain a result indicating whether the model checking result meets the EMC standard requirement, if so, entering S4, and if not, returning to S2;
s4: performing risk evaluation on other models except the representative model, and outputting risk items;
s5: synthesizing the risk items to obtain a result of whether the risk is acceptable, if so, entering S6, and if not, returning to S4;
s6: and outputting an evaluation report.
2. The evaluation method for electromagnetic compatibility model of medical air pressurization oxygen chamber according to claim 1, wherein in S1, a typicality screening is performed, comprising:
s1.1: classifying the medical air pressurization oxygen chamber into a plurality of sub-categories;
s1.2: at least one typical model is selected from each subcategory as a representative model according to typical characteristics;
s1.3: and performing supplementary improvement on the representative model.
3. The evaluation method of electromagnetic compatibility type of medical air pressurized oxygen chamber according to claim 2,
in S1.1, the medical air pressurization oxygen chambers are classified according to one or more of the following parameters: the medical air pressurization oxygen chamber has the functions, the composition, the wiring, the chamber body layout, the auxiliary function, the control mode, the chamber body size, the composition and the distribution of a control console and core electrical components.
4. The method for evaluating the electromagnetic compatibility model of the medical air pressurization oxygen chamber according to claim 1, wherein in S2, the representative model test comprises:
running a measuring program by using an electromagnetic disturbance measuring instrument, and measuring an emission index of the medical air pressurization oxygen cabin;
performing transient immunity test on the medical air pressurization oxygen cabin by using an electrostatic discharge test device, a pulse group test device, a surge test device, a power frequency test device and a voltage sag or interruption test device;
and running a conduction immunity and radiation immunity test program by using test equipment to test the conduction immunity and radiation immunity of the medical air pressurization oxygen chamber.
5. The method for evaluating the electromagnetic compatibility model of the medical air pressurization oxygen chamber according to claim 4, wherein in the step S3, the representative model test result is compared with the EMC standard to obtain a result indicating whether the model test result meets the EMC standard, and the determination step is:
s3.1: judging whether the emission index meets the requirement or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.2: judging whether all the immunity tests meet the requirements or not according to relevant national standards or industrial standards of electromagnetic compatibility;
s3.3: if the emission index and the immunity test of each representative model meet the requirements, the representative model meets the requirements of relevant standards of electromagnetic compatibility;
s3.4: all the emission indexes and the immunity tests of all the representative models meet the requirements, and the registration unit of the medical air pressurization oxygen chamber is regarded as meeting the requirements;
s3.5: and if the requirements are not met, performing relevant modification on the sample, repeating the step S2 and the steps S3.1-S3.4 until the requirements are met, and simultaneously recording representative models and projects which do not meet the requirements.
6. The evaluation method for electromagnetic compatibility model of medical air pressurization oxygen chamber according to claim 1, wherein in S4, the outputting risk item includes:
s4.1: identifying a danger source: according to the configuration of the medical air pressurization oxygen chamber, the danger of each functional module related to electromagnetic compatibility is obtained, and therefore a danger source is identified;
s4.2: risk estimation: according to the EMC danger condition of the medical air pressurization oxygen chamber, estimating the risk severity and the risk probability grade qualitatively, and integrating the risk severity and the risk probability grade to obtain the risk grade;
s4.3: judging whether the risk needs to be reduced: according to the risk level, the following steps are carried out:
firstly, establishing an acceptable criterion of risk;
secondly, traversing all foreseeable event sequences, screening unacceptable risks according to the risk grade and the acceptable criterion, and setting the unacceptable risks as risks to be reduced;
s4.4: and (3) risk control:
firstly, taking corresponding risk control measures according to a specific event sequence;
secondly, verifying the effectiveness of the risk control measures;
finally, whether the risk control measures introduce new risks or influence is judged to be acceptable risks is checked, and if any one of the situations exists, the S4.2 is returned for the risk control measures, the introduced new risks or the influenced acceptable risks;
s4.5: determining whether the remaining risk is acceptable:
firstly, after a risk control measure is taken, the residual risk is evaluated again, and the residual risk is determined to accord with an acceptable criterion;
secondly, if the residual risk is not acceptable, supplementing the representative model and completing the inspection;
s4.6: the remaining risk is output as a risk item.
7. The method for evaluating the electromagnetic compatibility model of the medical air pressurization oxygen chamber according to claim 1 or 6, wherein in the step S5, the step of integrating the risk items to obtain the result of whether the risk is acceptable comprises the following steps:
s5.1: checking for remaining risk: the remaining risk that may remain is checked from the following five aspects: evaluating a drawing, evaluating a construction process, evaluating a key part list, and judging whether a new risk and an electrical relevance risk are caused by a rectification measure;
s5.2: determining whether it is acceptable: if the comprehensive residual risk meets the acceptable criterion, the comprehensive residual risk is regarded as acceptable risk, and an evaluation conclusion is output; otherwise, the models with the remaining risks should be subjected to risk evaluation of other models again until the comprehensive remaining risks of the remaining models are acceptable risks.
8. The method of claim 1, wherein the evaluation report includes a test report representative of the model and an evaluation instruction.
9. The evaluation method of electromagnetic compatibility model of medical air pressurized oxygen chamber according to claim 6, wherein the supplementary representative model is selected from the group consisting of:
performing addition according to the inspection data and analysis; or, the modification measure application situation adopted by the representative model which is detected to be qualified is added.
10. The method for evaluating the electromagnetic compatibility model of the medical air pressurization oxygen chamber according to claim 9, wherein the inspection data is inspection data of a typical model or pretest data of a random model.
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