CN113984963A - Method for detecting conventional performance of medical protective equipment finished product for preventing new coronary pneumonia - Google Patents
Method for detecting conventional performance of medical protective equipment finished product for preventing new coronary pneumonia Download PDFInfo
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Abstract
The invention belongs to the technical field of medical protector detection, and discloses a method for detecting the conventional performance of a finished medical protector product for preventing new coronary pneumonia, which comprises the following steps of research on the influence of production process quality control on the medical protection performance and the new technical research on the detection and evaluation of medical protectors, wherein A, the research on the influence of the production process quality control on the medical protection performance comprises the following steps: the method comprises the following steps: the research on the influence of the production process quality control on the medical protective performance comprises the research on the relation between the sterilization and analysis time and the residual quantity of the ethylene oxide. The invention introduces an international new detection and evaluation method based on human body simulation, real environment simulation and modern instrument analysis technology through re-innovation after absorption, establishes a key index detection technology and a standardization method of the medical protective product to enable international and domestic standards to be met, enables the new crown pneumonia defense inspection to have a standard which can be relied on, and is beneficial to the high-quality development of the medical protective product in China and establishes a comprehensive guarantee system of the medical protective product for the new crown virus pneumonia emergency.
Description
Technical Field
The invention belongs to the technical field of medical protector detection, and particularly relates to a method for detecting the conventional performance of a medical protector finished product for defending new coronary pneumonia.
Background
The novel coronavirus pneumonia mainly shows fever, dry cough, hypodynamia and the like, a few patients are accompanied with upper respiratory tract and digestive tract symptoms such as nasal obstruction, rhinorrhoea, diarrhea and the like, the medical protective clothing is an indispensable defense device in defending the new coronavirus pneumonia, and the medical protective clothing needs to be subjected to routine performance detection before being put into use.
The medical protective clothing mainly comprises medical protective clothing, a medical mask, medical gloves, isolation clothes, alcohol cotton sheets and the like, and the current domestic standard and the European Union standard have more differences in indexes and detection methods, such as: the water impermeability and the surface moisture resistance are inconsistent in the selection of target objects, and the international and domestic standards are not in line, so that the defense inspection of the new coronary pneumonia is 'free from the standard and can not be relied on', and the high-quality development of medical protective products in China is not facilitated, and a comprehensive guarantee system of the medical protective products for the new coronary pneumonia emergency is established.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a method for detecting the conventional performance of a medical protective equipment finished product for defending new coronary pneumonia, which has the advantages that the international and domestic standards are met, the 'standard and the proof test of the new coronary pneumonia can be met', the high-quality development of medical protective products in China is facilitated, and a comprehensive guarantee system of the medical protective products for the new coronary pneumonia virus emergency is established.
In order to achieve the purpose, the invention provides the following technical scheme: a method for detecting the conventional performance of a medical protective tool finished product for defending new coronary pneumonia comprises the research on the influence of production process quality control on the medical protective performance and the new technical research on the detection and evaluation of medical protective articles, and is characterized in that:
A. the research on the influence of the production process quality control on the medical protective performance comprises the following steps:
the method comprises the following steps: the research on the influence of the production process quality control on the medical protective performance comprises the research on the relation between the sterilization and analysis time of the ethylene oxide and the residual quantity;
step two: research on influence of cobalt 60 or electron beam irradiation and material mechanics;
step three: research on influence of cobalt 60 or electron beam irradiation on the shelf life of a finished product;
step four: researching the influence of the drill 60 or electron beam irradiation and the irradiation residual quantity;
step five: researching the influence of the appearance design and the fitting degree of the medical protective mask;
step six: research on influence of material processing on filtering efficiency and research on use comfort and environmental compatibility of medical protective products;
B. the novel technical research on the detection and evaluation of the medical protective product comprises the following steps:
the method comprises the following steps: the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the following steps:
step two: the medical protective product sterility test method based on rapid detection of biological indicators comprises the following steps:
step three: researching a medical protective product virus filtration efficiency detection method based on phage evaluation;
step four: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step five: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step six: researching the feasibility of the medical protective product in detection indexes such as exhalation/inhalation resistance, formaldehyde, pH value, decoloration and the like;
the seventh step: establishing a comfort evaluation and detection method based on a medical protective product comfort detection technology of human body simulation;
the step of researching the relation between the ethylene oxide sterilization analysis time and the residual quantity in the step A is as follows;
the method comprises the following steps: continuously observing residual quantity conditions within 3 to 14 days by adopting different ethylene oxide sterilization dosage;
step two: recording the observed residual quantity, carrying out curve simulation, and establishing a release equation;
step three: evaluating the release condition in a short term according to a release equation;
the research on the influence of drilling 60 or electron beam irradiation and material mechanics in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: recording indexes of the detection material, such as elongation at break, tensile strength, antistatic property, surface moisture resistance, filtering efficiency, liquid splashing and the like;
step three: analyzing the obtained data;
the research on the influence of drilling 60 or electron beam irradiation and the shelf life of the finished product in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: storing the detection materials irradiated by the drills 60 with different dosages or the electron beams;
step three: sterility testing was performed for 20 days, 30 days, 50 days, 80 days, 100 days, 150 days and 200 days, respectively, under normal storage conditions;
step four: after all the detection, the obtained detection data is evaluated for reasonable shelf life;
a link of research on appearance design and tightness influence of the traditional Chinese medicine protective mask comprises the following steps;
the method comprises the following steps: selecting a nose clip, a mask body, materials and the like;
step two: adopting human body models with different specifications to wear the medical protective mask;
step three: carrying out conformity detection on the worn human body model, and judging whether the human body model is qualified or not by more than 8 of 10 persons;
in the B link, the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the detection of wear resistance, flexibility fastness, puncture performance, trapezoidal tear strength, seam strength, connection and assembly tension and the like, and the detection steps are as follows:
the method comprises the following steps: sampling the medical protective product to be detected;
step two: preventing the sampled material from being fixed on a detection mechanism;
step three: carrying out operations such as friction, stretching, puncturing, tearing and the like on the material;
step four: detecting whether the material detected in the third step is damaged or not;
step five: obtaining and recording a detection result;
the research on the medical protective product sterile detection method based on rapid detection of the biological indicator in the B link comprises the following steps:
the method comprises the following steps: incubating the biological indicator sample;
step two: detecting whether the biological indicator sample is qualified or not;
step three: contacting a biological indicator sample with the sample having undergone the detection result;
step four: storing for 2 days;
step five: analyzing the stored sample, detecting the quantity of the biological indicators on the sample, and recording;
in the step B, the research of the detection method for the liquid splashing, the moisture resistance and the permeability of the medical protective product based on the multi-component polymorphic test medium comprises the following steps;
step one, sampling a medical protective product;
step two: contacting one surface of a sample with acidic, alkaline, synthetic blood, o-xylene, n-butanol, water and other liquids and aerosols;
step three: taking down the sample, and turning over the sample;
step four: and observing the quantity of acid, alkali, synthetic blood, o-xylene, n-butanol, water and other liquid and aerosol existing on the other surface of the sample, and drawing a conclusion, wherein the achievement conversion application research promotes the detection and evaluation technical achievement in a standardized method form and is used for inspection, control, supervision and inspection of national new coronavirus prevention and control medical materials.
Preferably, in the research on the influence of the production process quality control on the medical protective performance, the influence of different sterilization modes (ethylene oxide, diamond 60, electron beams and the like), different material combinations (SMS, SS and SSS), different process parameters (appearance design, conformity design and filterability design) on the protective performance of the medical protective product, the conformity of international national standard requirements, particularly the capability of defending high-risk pollutants such as new crown viruses and the like, are intensively researched, the detection and judgment on the protective performance of the medical protective product are realized by researching the influence of different sterilization modes, different material combinations and different process parameters on the protective performance of the medical protective product, and unqualified medical protective products are screened and eliminated.
Preferably, after the research on the new technology for detecting and evaluating the medical protective product, the technology for detecting the indexes such as mechanical indexes such as abrasion resistance, flexibility resistance and puncture resistance, filtering performance such as viruses and aerosol, liquid splashing resistance, inward permeation and biological indicators of the medical protective product in the achievement transformation application research is also needed to be researched, a scientific system for evaluating the quality and safety of the medical protective product is established, the international orbit is realized, a standardized detection method is developed, and the intuitive judgment on whether the medical protective product meets the national standard and the European Union standard or not is realized by performing mechanical test and index detection technology on the medical protective product.
Preferably, the residual quantity observed in the research on the relationship between the ethylene oxide sterilization analysis time and the residual quantity in the A link is recorded and is required in curve simulation, the mask sterilized by ethylene oxide, the residual quantity of ethylene oxide is not more than 10ug/g, the selection of nose clip, mask body and material in the research of appearance design and tightness influence of the traditional Chinese medicine protective mask in the A link requires that the surface of the medical protective mask is not provided with broken holes and stains, an expiratory valve is not required, the medical protective mask is provided with the nose clip and the nose clip is adjustable, the inspection requires that 3 masks are taken, under the illumination of 3001x to 7001x, the eye force examination meets the requirements, the length of the nose clip is not less than 8.5cm, the standard and standardized management is carried out on the selected medical protective mask, unqualified medical protective masks are directly discharged from the aspects of appearance, strength and structure, and the inspection efficiency is greatly improved.
Preferably, in the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation in the B link, the stretching force required to the sample material in the operations of rubbing, stretching, puncturing, tearing and the like on the material is between 12N and 15N, and the deformation quantity before and after stretching is not more than one centimeter, in the research of the medical protective product sterile detection method based on rapid detection of the biological indicator in the B link, the filtering efficiency of the medical protective product is required to be not less than 95% under the condition of air flow (85 +/-5) L/min when liquid such as acidity, alkalinity, synthetic blood, o-xylene, N-butanol, water and the like and aerosol are contacted with one surface of the sample, namely, the filtering efficiency of the medical protective product is required to be not less than 95% under the condition of air flow (85 +/-5) L/min, namely, the medical protective product meets the grade of N95 (or FFP2) and the suction resistance is not more than 343.2Pa (35mmH2O), by means of re-innovation after absorption, based on human body simulation, real environment simulation and modern instrument analysis technology, an international new detection and evaluation method is introduced, and a key index detection technology and a standardization method of the medical protective product are established to enable international and domestic standards to be met, so that the new crown pneumonia defense inspection has a standard which can be relied on, and the comprehensive guarantee system of the medical protective product for the new crown virus pneumonia emergency event is favorable for high-quality development of the medical protective product in China.
Preferably, in the B link, a human simulation and environment simulation method is adopted for researching a multi-parameter mechanical index detection method based on human simulation and environment real simulation, a full set of detection technologies of human simulation, environment use simulation, constant temperature and humidity processing index detection and performance evaluation are established, systematic detection of the medical protective product is obtained by establishing a full set of detection technical scheme of the system, and domestic detection of the medical protective product has certain reference indication performance.
Preferably, in the B link, a modern instrument analysis method is adopted in the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation, aiming at phage filtration efficiency, multidirectional mechanical properties, biological indicators, formaldehyde and the like, a filtration efficiency tester, a large-scale tensile testing machine, microorganism culture, a chromatographic mass spectrum and other modern instruments are adopted for analysis technology, a high-sensitivity and high-precision detection method is established, the detection precision of the medical protective product is ensured by establishing the high-sensitivity and high-precision detection method, and the detection stability is ensured.
Compared with the prior art, the invention has the following beneficial effects:
the invention introduces an international new detection and evaluation method based on human body simulation, real environment simulation and modern instrument analysis technology through re-innovation after absorption, establishes a key index detection technology and a standardization method of the medical protective product to enable international and domestic standards to be met, enables the new crown pneumonia defense inspection to have a standard which can be relied on, and is beneficial to the high-quality development of the medical protective product in China and establishes a comprehensive guarantee system of the medical protective product for the new crown virus pneumonia emergency.
Drawings
FIG. 1 is a schematic view of the structure inspection process of the present invention.
Detailed Description
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.
The invention provides a technical scheme that: a method for detecting the conventional performance of a medical protective tool finished product for defending new coronary pneumonia comprises the research on the influence of production process quality control on the medical protective performance and the new technical research on the detection and evaluation of medical protective articles, and is characterized in that:
A. the research on the influence of the production process quality control on the medical protective performance comprises the following steps:
the method comprises the following steps: the research on the influence of the production process quality control on the medical protective performance comprises the research on the relation between the sterilization and analysis time of the ethylene oxide and the residual quantity;
step two: research on influence of cobalt 60 or electron beam irradiation and material mechanics;
step three: research on influence of cobalt 60 or electron beam irradiation on the shelf life of a finished product;
step four: researching the influence of the drill 60 or electron beam irradiation and the irradiation residual quantity;
step five: researching the influence of the appearance design and the fitting degree of the medical protective mask;
step six: research on influence of material processing on filtering efficiency and research on use comfort and environmental compatibility of medical protective products;
B. the novel technical research on the detection and evaluation of the medical protective product comprises the following steps:
the method comprises the following steps: the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the following steps:
step two: the medical protective product sterility test method based on rapid detection of biological indicators comprises the following steps:
step three: researching a medical protective product virus filtration efficiency detection method based on phage evaluation;
step four: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step five: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step six: researching the feasibility of the medical protective product in detection indexes such as exhalation/inhalation resistance, formaldehyde, pH value, decoloration and the like;
the seventh step: establishing a comfort evaluation and detection method based on a medical protective product comfort detection technology of human body simulation;
the step of researching the relation between the ethylene oxide sterilization analysis time and the residual quantity in the step A is as follows;
the method comprises the following steps: continuously observing residual quantity conditions within 3 to 14 days by adopting different ethylene oxide sterilization dosage;
step two: recording the observed residual quantity, carrying out curve simulation, and establishing a release equation;
step three: evaluating the release condition in a short term according to a release equation;
the research on the influence of drilling 60 or electron beam irradiation and material mechanics in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: recording indexes of the detection material, such as elongation at break, tensile strength, antistatic property, surface moisture resistance, filtering efficiency, liquid splashing and the like;
step three: analyzing the obtained data;
the research on the influence of drilling 60 or electron beam irradiation and the shelf life of the finished product in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: storing the detection materials irradiated by the drills 60 with different dosages or the electron beams;
step three: sterility testing was performed for 20 days, 30 days, 50 days, 80 days, 100 days, 150 days and 200 days, respectively, under normal storage conditions;
step four: after all the detection, the obtained detection data is evaluated for reasonable shelf life;
a link of research on appearance design and tightness influence of the traditional Chinese medicine protective mask comprises the following steps;
the method comprises the following steps: selecting a nose clip, a mask body, materials and the like;
step two: adopting human body models with different specifications to wear the medical protective mask;
step three: carrying out conformity detection on the worn human body model, and judging whether the human body model is qualified or not by more than 8 of 10 persons;
in the B link, the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the detection of wear resistance, flexibility fastness, puncture performance, trapezoidal tear strength, seam strength, connection and assembly tension and the like, and the detection steps are as follows:
the method comprises the following steps: sampling the medical protective product to be detected;
step two: preventing the sampled material from being fixed on a detection mechanism;
step three: carrying out operations such as friction, stretching, puncturing, tearing and the like on the material;
step four: detecting whether the material detected in the third step is damaged or not;
step five: obtaining and recording a detection result;
the research on the medical protective product sterile detection method based on rapid detection of the biological indicator in the B link comprises the following steps:
the method comprises the following steps: incubating the biological indicator sample;
step two: detecting whether the biological indicator sample is qualified or not;
step three: contacting a biological indicator sample with the sample having undergone the detection result;
step four: storing for 2 days;
step five: analyzing the stored sample, detecting the quantity of the biological indicators on the sample, and recording;
in the step B, the research of the detection method for the liquid splashing, the moisture resistance and the permeability of the medical protective product based on the multi-component polymorphic test medium comprises the following steps;
step one, sampling a medical protective product;
step two: contacting one surface of a sample with acidic, alkaline, synthetic blood, o-xylene, n-butanol, water and other liquids and aerosols;
step three: taking down the sample, and turning over the sample;
step four: and observing the quantity of acid, alkali, synthetic blood, o-xylene, n-butanol, water and other liquid and aerosol existing on the other surface of the sample, and drawing a conclusion, wherein the achievement conversion application research promotes the detection and evaluation technical achievement in a standardized method form and is used for inspection, control, supervision and inspection of national new coronavirus prevention and control medical materials.
Wherein, the influence of the quality control of the production process on the medical protective performance is mainly researched on the influence of different sterilization modes (ethylene oxide, diamond 60, electron beams and the like), different material combinations (SMS, SS and SSS), different process parameters (appearance design, conformity design and filterability design) on the protective performance of the medical protective product, the conformity of international national standard requirements, particularly the capability of defending high-risk pollutants such as new crown viruses and the like, the detection and judgment on the protective performance of the medical protective product are realized by researching the influence of different sterilization modes, different material combinations and different process parameters on the protective performance of the medical protective product, and unqualified medical protective products are screened and eliminated.
After the research of the new technology for detecting and evaluating the medical protective product, the detection technology for mainly researching mechanical indexes such as abrasion resistance, flexibility resistance and puncture resistance of the medical protective product, filtering performances such as viruses and aerosol, liquid splashing resistance, inward permeation, biological indicators and other indexes in the application research of achievements conversion is needed, a scientific system for evaluating the quality and safety of the medical protective product is established, international orbit is realized, a standardized detection method is developed, and whether the medical protective product meets the national standard and the European Union standard or not is intuitively judged by performing mechanical test and index detection technology on the medical protective product.
Wherein, the residual quantity observed in the research on the relationship between the ethylene oxide sterilization analysis time and the residual quantity in the A link is recorded and is required in curve simulation, the mask sterilized by ethylene oxide, the residual quantity of ethylene oxide is not more than 10ug/g, the selection of nose clip, mask body and material in the research of appearance design and tightness influence of the traditional Chinese medicine protective mask in the A link requires that the surface of the medical protective mask is not provided with broken holes and stains, an expiratory valve is not required, the medical protective mask is provided with the nose clip and the nose clip is adjustable, the inspection requires that 3 masks are taken, under the illumination of 3001x to 7001x, the eye force examination meets the requirements, the length of the nose clip is not less than 8.5cm, the standard and standardized management is carried out on the selected medical protective mask, unqualified medical protective masks are directly discharged from the aspects of appearance, strength and structure, and the inspection efficiency is greatly improved.
Wherein, in the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation in the B link, the stretching force required to the sample material in the operations of rubbing, stretching, puncturing, tearing and the like to the material is between 12N and 15N, and the deformation quantity before and after stretching is not more than one centimeter, in the research of the medical protective product aseptic detection method based on rapid detection of the biological indicator in the B link, the filtering efficiency of the medical protective product is required to be not less than 95 percent to the diameter value (0.24 +/-0.06) um sodium chloride aerosol in the aerodynamic under the condition of air flow (85 +/-5) L/min by using liquid such as acid, alkali, synthetic blood, o-xylene, N-butanol, water and the like and aerosol to be contacted with one surface of the sample, namely, the filtering efficiency accords with the N95 (or FFP2) and above grade, and the air suction resistance is not more than 343.2Pa (35mmH2O), by means of re-innovation after absorption, based on human body simulation, real environment simulation and modern instrument analysis technology, an international new detection and evaluation method is introduced, and a key index detection technology and a standardization method of the medical protective product are established to enable international and domestic standards to be met, so that the new crown pneumonia defense inspection has a standard which can be relied on, and the comprehensive guarantee system of the medical protective product for the new crown virus pneumonia emergency event is favorable for high-quality development of the medical protective product in China.
In the step B, human simulation and environment simulation methods are adopted for researching the multi-parameter mechanical index detection method based on human simulation and environment real simulation, a full set of detection technologies of human simulation, environment use simulation, constant temperature and humidity processing index detection and performance evaluation are established, systematic detection of the medical protective product is obtained by establishing a full set of detection technical scheme of the system, and domestic detection of the medical protective product has certain reference indication performance.
In the B link, a modern instrument analysis method is adopted in the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation, aiming at phage filtration efficiency, multidirectional mechanical properties, biological indicators, formaldehyde and the like, a filtration efficiency tester, a large-scale tensile testing machine, microorganism culture, a chromatographic mass spectrum and other modern instruments are adopted for analysis technology, and a high-sensitivity and high-precision detection method is established.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (7)
1. A method for detecting the conventional performance of a medical protective tool finished product for defending new coronary pneumonia comprises the research on the influence of production process quality control on the medical protective performance and the new technical research on the detection and evaluation of medical protective articles, and is characterized in that:
A. the research on the influence of the production process quality control on the medical protective performance comprises the following steps:
the method comprises the following steps: the research on the influence of the production process quality control on the medical protective performance comprises the research on the relation between the sterilization and analysis time of the ethylene oxide and the residual quantity;
step two: research on influence of cobalt 60 or electron beam irradiation and material mechanics;
step three: research on influence of cobalt 60 or electron beam irradiation on the shelf life of a finished product;
step four: researching the influence of the drill 60 or electron beam irradiation and the irradiation residual quantity;
step five: researching the influence of the appearance design and the fitting degree of the medical protective mask;
step six: research on influence of material processing on filtering efficiency and research on use comfort and environmental compatibility of medical protective products;
B. the novel technical research on the detection and evaluation of the medical protective product comprises the following steps:
the method comprises the following steps: the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the following steps:
step two: the medical protective product sterility test method based on rapid detection of biological indicators comprises the following steps:
step three: researching a medical protective product virus filtration efficiency detection method based on phage evaluation;
step four: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step five: the method is based on the detection method research of the liquid splashing, the moisture resistance and the permeability of the medical protective product of the multi-component polymorphic test medium;
step six: researching the feasibility of the medical protective product in detection indexes such as exhalation/inhalation resistance, formaldehyde, pH value, decoloration and the like;
the seventh step: establishing a comfort evaluation and detection method based on a medical protective product comfort detection technology of human body simulation;
the step of researching the relation between the ethylene oxide sterilization analysis time and the residual quantity in the step A is as follows;
the method comprises the following steps: continuously observing residual quantity conditions within 3 to 14 days by adopting different ethylene oxide sterilization dosage;
step two: recording the observed residual quantity, carrying out curve simulation, and establishing a release equation;
step three: evaluating the release condition in a short term according to a release equation;
the research on the influence of drilling 60 or electron beam irradiation and material mechanics in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: recording indexes of the detection material, such as elongation at break, tensile strength, antistatic property, surface moisture resistance, filtering efficiency, liquid splashing and the like;
step three: analyzing the obtained data;
the research on the influence of drilling 60 or electron beam irradiation and the shelf life of the finished product in the A link comprises the following steps:
the method comprises the following steps: setting different doses of drills 60 or electron beam irradiation;
step two: storing the detection materials irradiated by the drills 60 with different dosages or the electron beams;
step three: sterility testing was performed for 20 days, 30 days, 50 days, 80 days, 100 days, 150 days and 200 days, respectively, under normal storage conditions;
step four: after all the detection, the obtained detection data is evaluated for reasonable shelf life;
a link of research on appearance design and tightness influence of the traditional Chinese medicine protective mask comprises the following steps;
the method comprises the following steps: selecting a nose clip, a mask body, materials and the like;
step two: adopting human body models with different specifications to wear the medical protective mask;
step three: carrying out conformity detection on the worn human body model, and judging whether the human body model is qualified or not by more than 8 of 10 persons;
in the B link, the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation comprises the detection of wear resistance, flexibility fastness, puncture performance, trapezoidal tear strength, seam strength, connection and assembly tension and the like, and the detection steps are as follows:
the method comprises the following steps: sampling the medical protective product to be detected;
step two: preventing the sampled material from being fixed on a detection mechanism;
step three: carrying out operations such as friction, stretching, puncturing, tearing and the like on the material;
step four: detecting whether the material detected in the third step is damaged or not;
step five: obtaining and recording a detection result;
the research on the medical protective product sterile detection method based on rapid detection of the biological indicator in the B link comprises the following steps:
the method comprises the following steps: incubating the biological indicator sample;
step two: detecting whether the biological indicator sample is qualified or not;
step three: contacting a biological indicator sample with the sample having undergone the detection result;
step four: storing for 2 days;
step five: analyzing the stored sample, detecting the quantity of the biological indicators on the sample, and recording;
in the step B, the research of the detection method for the liquid splashing, the moisture resistance and the permeability of the medical protective product based on the multi-component polymorphic test medium comprises the following steps;
step one, sampling a medical protective product;
step two: contacting one surface of a sample with acidic, alkaline, synthetic blood, o-xylene, n-butanol, water and other liquids and aerosols;
step three: taking down the sample, and turning over the sample;
step four: and observing the amounts of acid, alkali, synthetic blood, o-xylene, n-butanol, water and other liquid and aerosol existing on the other surface of the sample, and drawing a conclusion.
2. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: in the research on the influence of the production process quality control on the medical protective performance, the influence of different sterilization modes (ethylene oxide, diamond 60, electron beams and the like), different material combinations (SMS, SS and SSS) and different process parameters (appearance design, conformity design and filterability design) on the protective performance of the medical protective product, the conformity of the international national standard requirements and particularly the capability of defending high-risk pollutants such as new coronavirus and the like are mainly researched.
3. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: after the research of the new technology for detecting and evaluating the medical protective product, the detection technology for mainly researching mechanical indexes of the medical protective product, such as abrasion resistance, flexibility and puncture resistance, filtering performances of viruses, aerosol and the like, liquid splashing resistance, inward permeation, biological indicators and the like in the research of conversion and application of achievements is needed, and a scientific system for evaluating the quality and safety of the medical protective product is established.
4. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: recording the observed residual quantity in the research on the relation between the ethylene oxide sterilization analysis time and the residual quantity in the A link, and carrying out the requirement in curve simulation, wherein the residual quantity of ethylene oxide of the mask sterilized by ethylene oxide is not more than 10ug/g, the mask body, materials and the like in the research on the appearance design and the tightness influence of the protective mask used in the A link in the traditional Chinese medicine requires that the surface of the medical protective mask is not provided with broken holes and stains, an exhalation valve is not required, a nose clip is required to be arranged and has adjustability, the inspection requirement is that 3 masks are taken, visual inspection is carried out under the illumination of 3001 x-7001 x, the requirements are met, and the length of the nose clip is not less than 8.5 cm.
5. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: in the B link, in the research of a multi-parameter mechanical index detection method based on human body simulation and environment real simulation, the stretching force of a sample material is required to be between 12N and 15N in the operations of rubbing, stretching, puncturing, tearing and the like on the material, and the deformation quantity before and after stretching is not more than one centimeter, in the research of a medical protective product sterile detection method based on rapid detection of a biological indicator, the filtering efficiency of a medical protective product is required to be not less than 95% under the condition of air flow (85 +/-5) L/min by using liquid such as acidity, alkalinity, synthetic blood, o-xylene, N-butanol, water and the like and aerosol, and the filtering effect of the medical protective product is required to be in contact with one surface of the sample, namely, the filtering efficiency is in accordance with N95 (or FFP2) and above, and the air suction resistance is not more than 343.2Pa (35mmH 2O).
6. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: in the step B, a human simulation and environment simulation method is adopted for researching a multi-parameter mechanical index detection method based on human simulation and environment real simulation, and a complete set of detection technology of human simulation, environment use simulation, constant temperature and humidity processing index detection and performance evaluation is established.
7. The method for detecting the conventional performance of the finished medical protector for defending against the new coronary pneumonia, which is disclosed by claim 1, is characterized in that: in the B link, a modern instrument analysis method is adopted in the research of the multi-parameter mechanical index detection method based on human body simulation and environment real simulation, and aiming at the phage filtration efficiency, multidirectional mechanical properties, biological indicators, formaldehyde and the like, a filtration efficiency tester, a large-scale tensile testing machine, microorganism culture, a chromatographic mass spectrum and other modern instruments are adopted to carry out analysis technology and establish a high-sensitivity and high-precision detection method.
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| CN116793901A (en) * | 2023-08-23 | 2023-09-22 | 江苏蓝格卫生护理用品有限公司 | Protective performance analysis method and system for medical protective clothing |
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